Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial.

Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW

Lancet (London, England)22 Apr 2021Cited by 241 (Europe PMC)

PMID33894838DOI10.1016/s0140-6736(21)00845-xPepBankPUB-33894838

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study29

20 results from studies that gave the peptide. 20 results from people.

01HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, adverse events occurred in 97% of participants given cagrilintide plus semaglutide and 96% given placebo plus semaglutide; the proportion was similar across groups and most events were mild to moderate.
In plain wordsIn adults with overweight, nearly everyone had some side effect, with similar rates on cagrilintide and placebo; most were mild or moderate.
Peptide
Cagrilintide
Outcome
No significant changeTreatment-emergent adverse events
Study
n = 95
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
0.16-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Participants with adverse events
97%
cagrilintide 0.16-4.5 mg
Participants with adverse events
96%
placebo
Source sentences
Summary
Of 566 adverse events reported in 92 participants (69 [97%] of 71 participants assigned to 0·16-4·5 mg cagrilintide and 23 [96%] of 24 assigned to placebo), 207 (37%) were gastrointestinal disorders. Most adverse events were mild to moderate in severity and the proportion of participants with one or…
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483801
02HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, 23 (96%) of 24 participants on semaglutide 2.4 mg with placebo reported adverse events.
In plain wordsIn adults with overweight or obesity, nearly all people taking semaglutide with placebo reported at least one side effect.
Peptide
Semaglutide
Outcome
Not applicableAdverse events (placebo plus semaglutide arm)
Study
n = 24
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Participants with adverse events
96%
placebo plus semaglutide 2.4 mg
Source sentences
Summary
Of 566 adverse events reported in 92 participants (69 [97%] of 71 participants assigned to 0·16-4·5 mg cagrilintide and 23 [96%] of 24 assigned to placebo)
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483813
03HumanRandomized controlled trialPharmacokinetics
In adults with overweight or obesity, cagrilintide did not affect semaglutide 2.4 mg exposure or elimination.
In plain wordsIn adults with overweight or obesity, adding cagrilintide did not change how much semaglutide stayed in the body or how fast it cleared.
Peptide
Semaglutide
Outcome
No significant changeEffect of cagrilintide on semaglutide exposure and elimination
Study
n = 95
Analysis
Secondary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Source sentences
Summary
did not affect semaglutide exposure or elimination.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483817
04HumanRandomized controlled trialPharmacokinetics
In adults with overweight or obesity, semaglutide 2.4 mg given with cagrilintide or placebo had an AUC0-168h of 12 757 to 15 305 nmol x h/L across cohorts.
In plain wordsIn adults with obesity, weekly semaglutide blood exposure, given with cagrilintide or placebo, ranged from 12 757 to 15 305 nmol x h/L.
Peptide
Semaglutide
Outcome
Not applicableSemaglutide AUC0-168h
Study
n = 95
Analysis
Secondary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
AUC0-168h
12,757 to 15,305 nmol × h/L
semaglutide 2.4 mg
Source sentences
Summary
AUC_{0-168 h} ranged from 12 757 nmol × h/L to 15 305 nmol × h/L, and C_max ranged from 96·4 nmol/L to 120 nmol/L with semaglutide 2·4 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483818
05HumanRandomized controlled trialPharmacokinetics
In adults with overweight or obesity, semaglutide 2.4 mg given with cagrilintide or placebo had a Cmax of 96.4 to 120 nmol/L across cohorts.
In plain wordsIn adults with overweight or obesity, peak semaglutide blood levels, given with cagrilintide or placebo, ranged from 96.4 to 120 nmol/L across cohorts.
Peptide
Semaglutide
Outcome
Not applicableSemaglutide Cmax
Study
n = 95
Analysis
Secondary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Cmax
96.4 to 120 nmol/L
semaglutide 2.4 mg
Source sentences
Summary
C_max ranged from 96·4 nmol/L to 120 nmol/L with semaglutide 2·4 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483819
06HumanRandomized controlled trialPharmacokinetics
Cagrilintide exposure was proportional to dose, with AUC0-168 h of 926 to 24 271 nmol x h/L and Cmax of 6.14 to 170 nmol/L across 0.16-4.5 mg.
In plain wordsIn adults with overweight, the amount of cagrilintide in the blood rose in proportion to the dose.
Peptide
Cagrilintide
Outcome
Not applicableCagrilintide exposure (AUC and Cmax)
Study
n: not reported in source
Analysis
Secondary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.16-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Cmax
6.14 to 170 nmol/L
cagrilintide 0.16-4.5 mg
Source sentences
Summary
Exposure was proportional to cagrilintide dose and did not affect semaglutide exposure or elimination. AUC_{0-168 h} ranged from 926 nmol × h/L to 24 271 nmol × h/L, and C_max ranged from 6·14 nmol/L to 170 nmol/L with cagrilintide 0·16-4·5 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483803
07HumanRandomized controlled trialPharmacokinetics
Cagrilintide did not affect semaglutide exposure or elimination.
In plain wordsIn adults with overweight, adding cagrilintide did not change how much semaglutide was in the blood or how fast it cleared.
Peptide
Cagrilintide
Outcome
No significant changeEffect of cagrilintide on semaglutide exposure and elimination
Study
n: not reported in source
Analysis
Secondary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.16-4.5 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
and did not affect semaglutide exposure or elimination.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483804
08HumanRandomized controlled trialPharmacokinetics
In adults with overweight or obesity, semaglutide 2.4 mg given with cagrilintide or placebo had a half-life of 145-165 h.
In plain wordsIn adults with overweight or obesity, semaglutide given with cagrilintide or placebo stayed in the body with a half-life of 145 to 165 hours.
Peptide
Semaglutide
Outcome
Not applicableSemaglutide half-life
Study
n = 95
Analysis
Exploratory
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Half-life
145 to 165 h
semaglutide 2.4 mg
Source sentences
Summary
Semaglutide 2·4 mg had a half-life of 145-165 h, with a median t_max of 12-24 h.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483820
09HumanRandomized controlled trialPharmacokinetics
In adults with overweight or obesity, semaglutide 2.4 mg given with cagrilintide or placebo had a median tmax of 12-24 h.
In plain wordsIn adults with overweight or obesity, semaglutide given with cagrilintide or placebo reached its peak blood level after a median of 12 to 24 hours.
Peptide
Semaglutide
Outcome
Not applicableSemaglutide time to Cmax
Study
n = 95
Analysis
Exploratory
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Median tmax
12 to 24 h
semaglutide 2.4 mg
Source sentences
Summary
with a median t_max of 12-24 h.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483821
10HumanRandomized controlled trialPharmacokinetics
Cagrilintide 0.16-4.5 mg had a half-life of 159-195 h.
In plain wordsIn adults with overweight, cagrilintide stayed in the body for a long time, with a half-life of 159 to 195 hours.
Peptide
Cagrilintide
Outcome
Not applicableCagrilintide half-life
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.16-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Half-life
159 to 195 h
cagrilintide 0.16-4.5 mg
Source sentences
Summary
Cagrilintide 0·16-4·5 mg had a half-life of 159-195 h, with a median t_max of 24-72 h.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483805
11HumanRandomized controlled trialPharmacokinetics
Cagrilintide 0.16-4.5 mg had a median tmax of 24-72 h.
In plain wordsIn adults with overweight, cagrilintide reached its highest blood level 24 to 72 hours after the dose.
Peptide
Cagrilintide
Outcome
Not applicableCagrilintide median tmax
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.16-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Median tmax
24 to 72 h
cagrilintide 0.16-4.5 mg
Source sentences
Summary
Cagrilintide 0·16-4·5 mg had a half-life of 159-195 h, with a median t_max of 24-72 h.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483806
12HumanRandomized controlled trialPharmacokinetics
Plasma clearance and volume of distribution of cagrilintide were similar across treatment groups.
In plain wordsIn adults with overweight, how fast cagrilintide cleared from the blood and spread in the body was similar across dose groups.
Peptide
Cagrilintide
Outcome
No significant changePlasma clearance and volume of distribution
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.16-4.5 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
Plasma clearance and volume of distribution for both cagrilintide and semaglutide were similar across treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483807
13HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity also given semaglutide 2.4 mg, cagrilintide 1.2 mg reduced bodyweight more than placebo at week 20 (15.7% vs 9.8%).
In plain wordsIn adults with overweight, cagrilintide 1.2 mg plus semaglutide led to more weight loss than placebo plus semaglutide after 20 weeks.
Peptide
Cagrilintide
Outcome
DecreasePercentage bodyweight change at week 20, cagrilintide 1.2 mg
Study
n: not reported in source
Comparator
Pooled placebo (cohorts 1-5)
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
1.2 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Bodyweight change
15.7%
cagrilintide 1.2 mg
Bodyweight change
9.8%
pooled placebo
Source sentences
Summary
15·7% [SE 1·6] for cagrilintide 1·2 mg and 17·1% [1·5] for cagrilintide 2·4 mg vs 9·8% [1·2] for pooled placebo cohorts 1-5; estimated treatment difference of -6·0% [95% CI -9·9 to -2·0]
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483808
14HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity also given semaglutide 2.4 mg, cagrilintide 2.4 mg reduced bodyweight more than placebo at week 20 (17.1% vs 9.8%).
In plain wordsIn adults with overweight, cagrilintide 2.4 mg plus semaglutide led to more weight loss than placebo plus semaglutide after 20 weeks.
Peptide
Cagrilintide
Outcome
DecreasePercentage bodyweight change at week 20, cagrilintide 2.4 mg
Study
n: not reported in source
Comparator
Pooled placebo (cohorts 1-5)
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Bodyweight change
17.1%
cagrilintide 2.4 mg
Bodyweight change
9.8%
pooled placebo
Source sentences
Summary
17·1% [1·5] for cagrilintide 2·4 mg vs 9·8% [1·2] for pooled placebo cohorts 1-5; estimated treatment difference of -6·0% [95% CI -9·9 to -2·0] for cagrilintide 1·2 mg and -7·4% [-11·2 to -3·5]
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483809
15HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity also given semaglutide 2.4 mg, cagrilintide 4.5 mg reduced bodyweight more than matched placebo at week 20 (15.4% vs 8.0%).
In plain wordsIn adults with overweight, cagrilintide 4.5 mg plus semaglutide led to more weight loss than matched placebo plus semaglutide after 20 weeks.
Peptide
Cagrilintide
Outcome
DecreasePercentage bodyweight change at week 20, cagrilintide 4.5 mg
Study
n: not reported in source
Comparator
Matched placebo
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
4.5 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Bodyweight change
15.4%
cagrilintide 4.5 mg
Bodyweight change
8%
matched placebo
Source sentences
Summary
and with cagrilintide 4·5 mg than with matched placebo (15·4% [1·3] vs 8·0% [2·2]; estimated treatment difference -7·4% [-12·8 to -2·1]
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483810
16HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity also given semaglutide 2.4 mg, glycaemic parameters improved in all treatment groups, including placebo, independently of cagrilintide dose.
In plain wordsIn adults with overweight, blood sugar measures improved in every group, including placebo, whatever the cagrilintide dose.
Peptide
Cagrilintide
Outcome
No significant changeGlycaemic parameters
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Glycaemic parameters improved in all treatment groups, independently of cagrilintide dose.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483811
17HumanRandomized controlled trialEfficacy outcome
Changes in hormones were similar across treatment groups.
In plain wordsIn adults with overweight, hormone changes were similar in the cagrilintide and placebo groups.
Peptide
Cagrilintide
Outcome
No significant changeHormone changes
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Hormone levels · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Changes in hormones were similar across treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483812
18HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, bodyweight fell by 9.8% at week 20 in the semaglutide 2.4 mg and placebo group, pooled cohorts 1-5.
In plain wordsIn adults with overweight or obesity, people taking semaglutide alone lost body weight by week 20.
Peptide
Semaglutide
Outcome
DecreaseBodyweight reduction at week 20 (placebo plus semaglutide, pooled cohorts 1-5)
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Bodyweight reduction
9.8%
pooled placebo cohorts 1-5 with semaglutide
Source sentences
Summary
9·8% [1·2] for pooled placebo cohorts 1-5; estimated treatment difference of -6·0% [95% CI -9·9 to -2·0] for cagrilintide 1·2 mg and -7·4% [-11·2 to -3·5] for cagrilintide 2·4 mg vs pooled placebo), and with cagrilintide 4·5 mg than with matched placebo (15·4% [1·3] vs 8·0% [2·2]; estimated treatmen…
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483823
19HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, bodyweight fell by 8.0% at week 20 in the semaglutide 2.4 mg and matched placebo group of the 4.5 mg cohort.
In plain wordsIn adults with overweight or obesity, people taking semaglutide alone lost about 8% of body weight by week 20 in one cohort.
Peptide
Semaglutide
Outcome
DecreaseBodyweight reduction at week 20 (placebo plus semaglutide, cohort 6)
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Bodyweight reduction
8%
matched placebo with semaglutide
Source sentences
Summary
(15·4% [1·3] vs 8·0% [2·2]; estimated treatment difference -7·4% [-12·8 to -2·1]), all in combination with semaglutide 2·4 mg.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483824
20HumanRandomized controlled trialSafety outcome
Of 566 adverse events reported in 92 participants, 207 (37%) were gastrointestinal disorders.
In plain wordsIn adults with overweight, about 37% of all reported side effects were stomach and gut problems.
Peptide
Cagrilintide
Outcome
Not applicableGastrointestinal adverse events share
Study
n = 92
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.16-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Gastrointestinal adverse events
207 events
of 566 events
Source sentences
Summary
Of 566 adverse events reported in 92 participants (69 [97%] of 71 participants assigned to 0·16-4·5 mg cagrilintide and 23 [96%] of 24 assigned to placebo), 207 (37%) were gastrointestinal disorders.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
Report a problemFND-3389483802

Studies that did not test the peptide alone9

In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Semaglutide.

21HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with overweight or obesity, 69 (97%) of 71 participants on cagrilintide 0.16-4.5 mg plus semaglutide 2.4 mg reported adverse events.
In plain wordsIn adults with overweight or obesity, nearly all people taking cagrilintide with semaglutide reported at least one side effect.
Peptide
Semaglutide
Outcome
Not applicableAdverse events (cagrilintide plus semaglutide arms)
Study
n = 71
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Participants with adverse events
97%
cagrilintide plus semaglutide
Source sentences
Summary
Of 566 adverse events reported in 92 participants (69 [97%] of 71 participants assigned to 0·16-4·5 mg cagrilintide
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483814
22HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with overweight or obesity, the share of participants with one or more adverse event was similar across cagrilintide plus semaglutide and placebo plus semaglutide groups, and most events were mild to moderate.
In plain wordsIn adults with overweight or obesity, side effects were mostly mild to moderate and about equally common across groups.
Peptide
Semaglutide
Outcome
No significant changeAdverse event proportion across groups
Study
n = 95
Analysis
Secondary
Outcome group
Adverse events · Whole body
Source sentences
Summary
Most adverse events were mild to moderate in severity and the proportion of participants with one or more adverse event was similar across treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483816
23HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with overweight or obesity, 207 (37%) of 566 adverse events in the cagrilintide plus semaglutide and placebo plus semaglutide groups were gastrointestinal disorders.
In plain wordsIn adults with overweight or obesity, about a third of side effects were stomach or gut problems.
Peptide
Semaglutide
Outcome
Not applicableGastrointestinal adverse events
Study
n = 92
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Gastrointestinal share of adverse events
37%
all participants
Source sentences
Summary
207 (37%) were gastrointestinal disorders.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483815
24HumanNot a test of Semaglutide aloneRandomized controlled trialPharmacokinetics
In adults with overweight or obesity, plasma clearance and volume of distribution for cagrilintide and semaglutide were similar across treatment groups.
In plain wordsIn adults with overweight or obesity, how fast the two drugs cleared and spread in the body was similar across groups.
Peptide
Semaglutide
Outcome
No significant changePlasma clearance and volume of distribution across groups
Study
n = 95
Analysis
Exploratory
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
Plasma clearance and volume of distribution for both cagrilintide and semaglutide were similar across treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483822
25HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, glycaemic parameters improved in all treatment groups, including placebo plus semaglutide, independent of cagrilintide dose.
In plain wordsIn adults with overweight or obesity, blood sugar measures improved in every group, whatever the cagrilintide dose.
Peptide
Semaglutide
Outcome
Direction not reportedGlycaemic parameters
Study
n = 95
Analysis
Exploratory
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
Glycaemic parameters improved in all treatment groups, independently of cagrilintide dose.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483828
26HumanNot a test of Semaglutide aloneRandomized controlled trialMechanism
In adults with overweight or obesity, changes in hormones were similar across cagrilintide plus semaglutide and placebo plus semaglutide groups.
In plain wordsIn adults with overweight or obesity, hormone changes were similar across treatment groups.
Peptide
Semaglutide
Outcome
No significant changeHormone changes across groups
Study
n = 95
Analysis
Exploratory
Outcome group
Receptor activity and mechanism · Endocrine and hormones
Source sentences
Summary
Changes in hormones were similar across treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483829
27HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, cagrilintide 1.2 mg plus semaglutide 2.4 mg reduced bodyweight by 15.7% at week 20, more than placebo plus semaglutide.
In plain wordsIn adults with overweight or obesity, cagrilintide plus semaglutide gave more weight loss than semaglutide alone at week 20.
Peptide
Semaglutide
Outcome
DecreaseBodyweight reduction at week 20 with cagrilintide 1.2 mg plus semaglutide
Study
n: not reported in source
Comparator
Pooled placebo plus semaglutide
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Measurements
Bodyweight reduction
15.7%
cagrilintide 1.2 mg plus semaglutide
Estimated treatment difference
−6%
vs pooled placebo
Source sentences
Summary
mean percentage bodyweight reductions were greater with cagrilintide 1·2 and 2·4 mg than with placebo (15·7% [SE 1·6] for cagrilintide 1·2 mg and 17·1% [1·5] for cagrilintide 2·4 mg vs 9·8% [1·2] for pooled placebo cohorts 1-5; estimated treatment difference of -6·0% [95% CI -9·9 to -2·0] for cagrilintide 1·2 mg
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483825
28HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, cagrilintide 2.4 mg plus semaglutide 2.4 mg reduced bodyweight by 17.1% at week 20, more than placebo plus semaglutide.
In plain wordsIn adults with overweight or obesity, cagrilintide plus semaglutide gave more weight loss than semaglutide alone at week 20.
Peptide
Semaglutide
Outcome
DecreaseBodyweight reduction at week 20 with cagrilintide 2.4 mg plus semaglutide
Study
n: not reported in source
Comparator
Pooled placebo plus semaglutide
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Measurements
Bodyweight reduction
17.1%
cagrilintide 2.4 mg plus semaglutide
Estimated treatment difference
−7.4%
vs pooled placebo
Source sentences
Summary
17·1% [1·5] for cagrilintide 2·4 mg vs 9·8% [1·2] for pooled placebo cohorts 1-5; estimated treatment difference of -6·0% [95% CI -9·9 to -2·0] for cagrilintide 1·2 mg and -7·4% [-11·2 to -3·5] for cagrilintide 2·4 mg vs pooled placebo
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483826
29HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, cagrilintide 4.5 mg plus semaglutide 2.4 mg reduced bodyweight by 15.4% at week 20, more than matched placebo plus semaglutide.
In plain wordsIn adults with overweight or obesity, cagrilintide plus semaglutide gave more weight loss than semaglutide alone at week 20.
Peptide
Semaglutide
Outcome
DecreaseBodyweight reduction at week 20 with cagrilintide 4.5 mg plus semaglutide
Study
n: not reported in source
Comparator
Matched placebo plus semaglutide
Analysis
Exploratory
Outcome group
Body weight · Metabolic and weight
Measurements
Bodyweight reduction
15.4%
cagrilintide 4.5 mg plus semaglutide
Estimated treatment difference
−7.4%
vs matched placebo
Source sentences
Summary
and with cagrilintide 4·5 mg than with matched placebo (15·4% [1·3] vs 8·0% [2·2]; estimated treatment difference -7·4% [-12·8 to -2·1])
2 context sentences(design, population, supporting numbers)
Summary · context
In this randomised, placebo-controlled, multiple-ascending dose, phase 1b trial, individuals aged 18-55 years with a body-mass index 27·0-39·9 kg/m² and who were otherwise healthy were recruited from a single centre in the USA.
Summary · context
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without l…
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3389483827

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT03600480

A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

Novo Nordisk A/Sn = 9625 Jul 2018 to 12 Jun 2020

Obesity · Overweight

Trial page ClinicalTrials.govUpdated 17 Nov 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Versions 3 to 38Current
28 Oct 2026, 02:04 UTC
The same notice was added 36 times, first on 9 Oct 2026, 18:17 UTC. The status did not change between them.
Study results updated
Version 2
9 Oct 2026, 03:06 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC