Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.

Frias JP, Deenadayalan S, Erichsen L, Knop FK, Lingvay I, Macura S, Mathieu C, Pedersen SD, Davies M

Lancet (London, England)23 Jun 2023Cited by 248 (Europe PMC)

PMID37364590DOI10.1016/s0140-6736(23)01163-7PepBankPUB-37364590

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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 study35

19 results from studies that gave the peptide. 19 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adding semaglutide to cagrilintide (CagriSema) lowered HbA1c more than cagrilintide alone at week 32.
In plain wordsIn adults with type 2 diabetes, cagrilintide plus semaglutide lowered HbA1c more than cagrilintide alone.
Peptide
Semaglutide
Outcome
DecreaseHbA1c: CagriSema versus cagrilintide alone
Study
n = 61
Comparator
Cagrilintide 2.4 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Estimated treatment difference in HbA1c
−1.3 percentage points
CagriSema vs cagrilintide
Source sentences
Summary
was greater with CagriSema versus cagrilintide (estimated treatment difference -1·3 percentage points [95% CI -1·7 to -0·8]; p<0·0001)
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459021
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, semaglutide 2.4 mg lowered HbA1c by 1.8 percentage points from baseline to week 32.
In plain wordsIn adults with type 2 diabetes, semaglutide lowered HbA1c, a measure of blood sugar control, over 32 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change from baseline to week 32 (semaglutide arm)
Study
n = 31
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
HbA1c change
−1.8 percentage points
semaglutide 2.4 mg
Source sentences
Summary
The mean change in HbA_1c from baseline to week 32 (CagriSema: -2·2 percentage points [SE 0·15]; semaglutide: -1·8 percentage points [0·16]; cagrilintide: -0·9 percentage points [0·15])
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459020
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, HbA1c fell by 0.9 percentage points from baseline to week 32 with cagrilintide alone.
In plain wordsIn adults with type 2 diabetes, HbA1c fell by 0.9 percentage points over 32 weeks of cagrilintide alone.
Peptide
Cagrilintide
Outcome
DecreaseHbA1c change from baseline, cagrilintide
Study
n = 30
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Measurements
HbA1c change from baseline
−0.9 percentage points
cagrilintide
Source sentences
Summary
The mean change in HbA_1c from baseline to week 32 (CagriSema: -2·2 percentage points [SE 0·15]; semaglutide: -1·8 percentage points [0·16]; cagrilintide: -0·9 percentage points [0·15])
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459004
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the HbA1c change at week 32 with CagriSema was not significantly different from semaglutide alone.
In plain wordsIn adults with type 2 diabetes, CagriSema did not lower HbA1c significantly more than semaglutide alone.
Peptide
Cagrilintide
Outcome
No significant changeHbA1c change, CagriSema vs semaglutide
Study
n: not reported in source
Comparator
Semaglutide 2.4 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Measurements
HbA1c treatment difference
−0.4 percentage points
CagriSema vs semaglutide
Source sentences
Summary
but not versus semaglutide (-0·4 percentage points [-0·8 to 0·0]; p=0·075).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459002
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adding semaglutide to cagrilintide (CagriSema) reduced bodyweight more than cagrilintide alone at week 32.
In plain wordsIn adults with type 2 diabetes, cagrilintide plus semaglutide caused more weight loss than cagrilintide alone.
Peptide
Semaglutide
Outcome
DecreaseBodyweight: CagriSema versus cagrilintide alone
Study
n = 61
Comparator
Cagrilintide 2.4 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
was greater with CagriSema versus both semaglutide (p<0·0001) and cagrilintide (p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459025
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adding semaglutide to cagrilintide (CagriSema) lowered fasting plasma glucose more than cagrilintide alone.
In plain wordsIn adults with type 2 diabetes, cagrilintide plus semaglutide lowered fasting blood glucose more than cagrilintide alone.
Peptide
Semaglutide
Outcome
DecreaseFasting plasma glucose: CagriSema versus cagrilintide alone
Study
n = 61
Comparator
Cagrilintide 2.4 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
was greater with CagriSema versus cagrilintide (p=0·0010)
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459027
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide 2.4 mg reduced bodyweight by 5.1% from baseline to week 32.
In plain wordsIn adults with type 2 diabetes, semaglutide lowered body weight over 32 weeks.
Peptide
Semaglutide
Outcome
DecreaseBodyweight change from baseline to week 32 (semaglutide arm)
Study
n = 31
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Bodyweight change
−5.1%
semaglutide 2.4 mg
Source sentences
Summary
The mean change in bodyweight from baseline to week 32 (CagriSema: -15·6% [SE 1·26]; semaglutide: -5·1% [1·26]; cagrilintide: -8·1% [1·23])
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459023
08HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, semaglutide 2.4 mg lowered fasting plasma glucose by 2.5 mmol/L from baseline to week 32.
In plain wordsIn adults with type 2 diabetes, semaglutide lowered fasting blood glucose over 32 weeks.
Peptide
Semaglutide
Outcome
DecreaseFasting plasma glucose change from baseline to week 32 (semaglutide arm)
Study
n = 31
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Fasting plasma glucose change
−2.5 mmol/L
semaglutide 2.4 mg
Source sentences
Summary
The mean change in fasting plasma glucose from baseline to week 32 (CagriSema: -3·3 mmol/L [SE 0·3]; semaglutide: -2·5 mmol/L [0·4]; cagrilintide: -1·7 mmol/L [0·3])
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459026
09HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, time in glucose range (3.9-10.0 mmol/L) rose from 32.6% at baseline to 76.2% at week 32 with semaglutide 2.4 mg.
In plain wordsIn adults with type 2 diabetes, semaglutide increased the share of time with blood glucose in the target range.
Peptide
Semaglutide
Outcome
IncreaseTime in glucose range at week 32 (semaglutide arm)
Study
n = 31
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Time in range
32.6%
semaglutide baseline
Time in range
76.2%
semaglutide week 32
Source sentences
Summary
Time in range (3·9-10·0 mmol/L) was 45·9%, 32·6%, and 56·9% at baseline and 88·9%, 76·2%, and 71·7% at week 32 with CagriSema, semaglutide, and cagrilintide, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459029
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 22 (71%) participants on semaglutide 2.4 mg reported adverse events.
In plain wordsIn adults with type 2 diabetes, about seven in ten people taking semaglutide reported a side effect.
Peptide
Semaglutide
Outcome
Not applicableAny adverse event (semaglutide arm)
Study
n = 31
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Participants with adverse events
71%
semaglutide 2.4 mg
Source sentences
Summary
Adverse events were reported by 21 (68%) participants in the CagriSema group, 22 (71%) in the semaglutide group
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459031
11HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, body weight fell by 8.1% from baseline to week 32 with cagrilintide alone.
In plain wordsIn adults with type 2 diabetes, body weight fell by 8.1% over 32 weeks of cagrilintide alone.
Peptide
Cagrilintide
Outcome
DecreaseBodyweight change from baseline, cagrilintide
Study
n = 30
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Bodyweight change from baseline
−8.1%
cagrilintide
Source sentences
Summary
The mean change in bodyweight from baseline to week 32 (CagriSema: -15·6% [SE 1·26]; semaglutide: -5·1% [1·26]; cagrilintide: -8·1% [1·23]) was greater with CagriSema versus both semaglutide (p<0·0001) and cagrilintide (p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459008
12HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 24 participants (80%) in the cagrilintide group reported adverse events.
In plain wordsIn adults with type 2 diabetes, 80% of people taking cagrilintide alone reported side effects.
Peptide
Cagrilintide
Outcome
Not applicableAdverse events, cagrilintide group
Study
n = 30
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Participants with adverse events
80%
cagrilintide
Source sentences
Summary
24 (80%) in the cagrilintide group.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459014
13HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, fasting plasma glucose fell by 1.7 mmol/L from baseline to week 32 with cagrilintide alone.
In plain wordsIn adults with type 2 diabetes, fasting blood glucose fell by 1.7 mmol/L over 32 weeks of cagrilintide alone.
Peptide
Cagrilintide
Outcome
DecreaseFasting plasma glucose change from baseline, cagrilintide
Study
n = 30
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Fasting plasma glucose change from baseline
−1.7 mmol/L
cagrilintide, week 32
Source sentences
Summary
The mean change in fasting plasma glucose from baseline to week 32 (CagriSema: -3·3 mmol/L [SE 0·3]; semaglutide: -2·5 mmol/L [0·4]; cagrilintide: -1·7 mmol/L [0·3]) was greater with CagriSema versus cagrilintide (p=0·0010) but not versus semaglutide (p=0·10).
Report a problemFND-3736459019
14HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, weight loss at week 32 was greater with CagriSema than with semaglutide alone.
In plain wordsIn adults with type 2 diabetes, CagriSema led to more weight loss than semaglutide alone.
Peptide
Cagrilintide
Outcome
DecreaseBodyweight change, CagriSema vs semaglutide
Study
n: not reported in source
Comparator
Semaglutide 2.4 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
The mean change in bodyweight from baseline to week 32 (CagriSema: -15·6% [SE 1·26]; semaglutide: -5·1% [1·26]; cagrilintide: -8·1% [1·23]) was greater with CagriSema versus both semaglutide (p<0·0001) and cagrilintide (p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459005
15HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the fasting plasma glucose change at week 32 with CagriSema was not significantly different from semaglutide alone (p=0.10).
In plain wordsIn adults with type 2 diabetes, CagriSema did not lower fasting blood glucose significantly more than semaglutide alone.
Peptide
Cagrilintide
Outcome
No significant changeFasting plasma glucose change, CagriSema vs semaglutide
Study
n: not reported in source
Comparator
Semaglutide 2.4 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
The mean change in fasting plasma glucose from baseline to week 32 (CagriSema: -3·3 mmol/L [SE 0·3]; semaglutide: -2·5 mmol/L [0·4]; cagrilintide: -1·7 mmol/L [0·3]) was greater with CagriSema versus cagrilintide (p=0·0010) but not versus semaglutide (p=0·10).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459010
16HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, time in range (3.9-10.0 mmol/L) rose from 56.9% at baseline to 71.7% at week 32 with cagrilintide alone.
In plain wordsIn adults with type 2 diabetes, time with glucose in the target range rose from 56.9% to 71.7% with cagrilintide alone.
Peptide
Cagrilintide
Outcome
IncreaseCGM time in range, cagrilintide
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Measurements
Time in range
71.7%
cagrilintide, week 32
Time in range
56.9%
cagrilintide, baseline
Source sentences
Summary
Time in range (3·9-10·0 mmol/L) was 45·9%, 32·6%, and 56·9% at baseline and 88·9%, 76·2%, and 71·7% at week 32 with CagriSema, semaglutide, and cagrilintide, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459012
17HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, mild or moderate gastrointestinal adverse events were the most common adverse events across the treatment arms.
In plain wordsIn adults with type 2 diabetes, mild or moderate stomach and gut side effects were the most common side effects.
Peptide
Cagrilintide
Outcome
Not applicableGastrointestinal adverse events
Study
n: not reported in source
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
Mild or moderate gastrointestinal adverse events were most common
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459015
18HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no level 2 or 3 hypoglycaemia was reported.
In plain wordsIn adults with type 2 diabetes, no serious low blood sugar events were reported.
Peptide
Cagrilintide
Outcome
No significant changeLevel 2 or 3 hypoglycaemia
Study
n: not reported in source
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
no level 2 or 3 hypoglycaemia was reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459016
19HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no fatal adverse events were reported.
In plain wordsIn adults with type 2 diabetes, no deaths from side effects were reported.
Peptide
Cagrilintide
Outcome
No significant changeFatal adverse events
Study
n: not reported in source
Analysis
Secondary
Outcome group
Mortality · Whole body
Studied dose
2.4 mg once weekly (escalated) · subcutaneous · 32 weeksAs given in this study (human).
Source sentences
Summary
No fatal adverse events were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Report a problemFND-3736459017

Studies that did not test the peptide alone16

In this study, the peptide 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 the peptide.

20HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the CagriSema combination did not lower HbA1c significantly more than semaglutide alone at week 32.
In plain wordsIn adults with type 2 diabetes, the combination product did not lower HbA1c significantly more than semaglutide alone.
Peptide
Semaglutide
Outcome
No significant changeHbA1c: CagriSema versus semaglutide alone
Study
n = 62
Comparator
Semaglutide 2.4 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Estimated treatment difference in HbA1c
−0.4 percentage points
CagriSema vs semaglutide
Source sentences
Summary
but not versus semaglutide (-0·4 percentage points [-0·8 to 0·0]; p=0·075).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459022
21HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, HbA1c fell by 2.2 percentage points from baseline to week 32 with CagriSema.
In plain wordsIn adults with type 2 diabetes, HbA1c fell by 2.2 percentage points over 32 weeks of CagriSema.
Peptide
Cagrilintide
Outcome
DecreaseHbA1c change from baseline, CagriSema
Study
n = 31
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change from baseline
−2.2 percentage points
CagriSema
Source sentences
Summary
The mean change in HbA_1c from baseline to week 32 (CagriSema: -2·2 percentage points [SE 0·15]; semaglutide: -1·8 percentage points [0·16]; cagrilintide: -0·9 percentage points [0·15])
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459003
22HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the HbA1c reduction at week 32 was greater with CagriSema than with cagrilintide alone.
In plain wordsIn adults with type 2 diabetes, CagriSema lowered HbA1c more than cagrilintide alone.
Peptide
Cagrilintide
Outcome
DecreaseHbA1c change, CagriSema vs cagrilintide
Study
n: not reported in source
Comparator
Cagrilintide 2.4 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c treatment difference
−1.3 percentage points
CagriSema vs cagrilintide
Source sentences
Summary
was greater with CagriSema versus cagrilintide (estimated treatment difference -1·3 percentage points [95% CI -1·7 to -0·8]; p<0·0001)
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459001
23HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, mild or moderate gastrointestinal adverse events were the most common events across the CagriSema, semaglutide and cagrilintide groups.
In plain wordsIn adults with type 2 diabetes, mild or moderate stomach and gut side effects were most common across the three treatment groups.
Peptide
Semaglutide
Outcome
Not applicableGastrointestinal adverse events
Study
n = 92
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
Mild or moderate gastrointestinal adverse events were most common
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459033
24HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no level 2 or 3 hypoglycaemia was reported in any treatment group.
In plain wordsIn adults with type 2 diabetes, no serious low blood sugar events were reported in any group.
Peptide
Semaglutide
Outcome
No significant changeLevel 2 or 3 hypoglycaemia
Study
n = 92
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
no level 2 or 3 hypoglycaemia was reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459034
25HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no fatal adverse events were reported in any treatment group.
In plain wordsIn adults with type 2 diabetes, no deaths from side effects were reported in any group.
Peptide
Semaglutide
Outcome
No significant changeFatal adverse events
Study
n = 92
Analysis
Secondary
Outcome group
Mortality · Whole body
Source sentences
Summary
No fatal adverse events were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459035
26HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the CagriSema combination reduced bodyweight more than semaglutide alone at week 32.
In plain wordsIn adults with type 2 diabetes, the combination product caused more weight loss than semaglutide alone.
Peptide
Semaglutide
Outcome
DecreaseBodyweight: CagriSema versus semaglutide alone
Study
n = 62
Comparator
Semaglutide 2.4 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Source sentences
Summary
was greater with CagriSema versus both semaglutide (p<0·0001) and cagrilintide (p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459024
27HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the CagriSema combination did not lower fasting plasma glucose significantly more than semaglutide alone.
In plain wordsIn adults with type 2 diabetes, the combination product did not lower fasting blood glucose significantly more than semaglutide alone.
Peptide
Semaglutide
Outcome
No significant changeFasting plasma glucose: CagriSema versus semaglutide alone
Study
n = 62
Comparator
Semaglutide 2.4 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
but not versus semaglutide (p=0·10).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459028
28HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, body weight fell by 15.6% from baseline to week 32 with CagriSema.
In plain wordsIn adults with type 2 diabetes, body weight fell by 15.6% over 32 weeks of CagriSema.
Peptide
Cagrilintide
Outcome
DecreaseBodyweight change from baseline, CagriSema
Study
n = 31
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Bodyweight change from baseline
−15.6%
CagriSema
Source sentences
Summary
The mean change in bodyweight from baseline to week 32 (CagriSema: -15·6% [SE 1·26]; semaglutide: -5·1% [1·26]; cagrilintide: -8·1% [1·23]) was greater with CagriSema versus both semaglutide (p<0·0001) and cagrilintide (p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459007
29HumanNot a test of Cagrilintide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 21 participants (68%) in the CagriSema group reported adverse events.
In plain wordsIn adults with type 2 diabetes, 68% of people taking CagriSema reported side effects.
Peptide
Cagrilintide
Outcome
Not applicableAdverse events, CagriSema group
Study
n = 31
Analysis
Secondary
Outcome group
Adverse events · Whole body
Measurements
Participants with adverse events
68%
CagriSema
Source sentences
Summary
Adverse events were reported by 21 (68%) participants in the CagriSema group
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459013
30HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, fasting plasma glucose fell by 3.3 mmol/L from baseline to week 32 with CagriSema.
In plain wordsIn adults with type 2 diabetes, fasting blood glucose fell by 3.3 mmol/L over 32 weeks of CagriSema.
Peptide
Cagrilintide
Outcome
DecreaseFasting plasma glucose change from baseline, CagriSema
Study
n = 31
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Fasting plasma glucose change from baseline
−3.3 mmol/L
CagriSema, week 32
Source sentences
Summary
The mean change in fasting plasma glucose from baseline to week 32 (CagriSema: -3·3 mmol/L [SE 0·3]; semaglutide: -2·5 mmol/L [0·4]; cagrilintide: -1·7 mmol/L [0·3]) was greater with CagriSema versus cagrilintide (p=0·0010) but not versus semaglutide (p=0·10).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459018
31HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, time in glucose range rose from 45.9% at baseline to 88.9% at week 32 with the CagriSema combination.
In plain wordsIn adults with type 2 diabetes, the combination product increased the share of time with blood glucose in the target range.
Peptide
Semaglutide
Outcome
IncreaseTime in glucose range at week 32 (CagriSema arm)
Study
n = 31
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Time in range
45.9%
CagriSema baseline
Time in range
88.9%
CagriSema week 32
Source sentences
Summary
Time in range (3·9-10·0 mmol/L) was 45·9%, 32·6%, and 56·9% at baseline and 88·9%, 76·2%, and 71·7% at week 32 with CagriSema, semaglutide, and cagrilintide, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459030
32HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 21 (68%) participants on the CagriSema combination reported adverse events.
In plain wordsIn adults with type 2 diabetes, about two in three people taking the combination product reported a side effect.
Peptide
Semaglutide
Outcome
Not applicableAny adverse event (CagriSema arm)
Study
n = 31
Analysis
Secondary
Outcome group
Adverse events · Whole body
Measurements
Participants with adverse events
68%
CagriSema
Source sentences
Summary
Adverse events were reported by 21 (68%) participants in the CagriSema group
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
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-3736459032
33HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, weight loss at week 32 was greater with CagriSema than with cagrilintide alone.
In plain wordsIn adults with type 2 diabetes, CagriSema led to more weight loss than cagrilintide alone.
Peptide
Cagrilintide
Outcome
DecreaseBodyweight change, CagriSema vs cagrilintide
Study
n: not reported in source
Comparator
Cagrilintide 2.4 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Source sentences
Summary
The mean change in bodyweight from baseline to week 32 (CagriSema: -15·6% [SE 1·26]; semaglutide: -5·1% [1·26]; cagrilintide: -8·1% [1·23]) was greater with CagriSema versus both semaglutide (p<0·0001) and cagrilintide (p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459006
34HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the fasting plasma glucose reduction at week 32 was greater with CagriSema than with cagrilintide alone (p=0.0010).
In plain wordsIn adults with type 2 diabetes, CagriSema lowered fasting blood glucose more than cagrilintide alone.
Peptide
Cagrilintide
Outcome
DecreaseFasting plasma glucose change, CagriSema vs cagrilintide
Study
n: not reported in source
Comparator
Cagrilintide 2.4 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Source sentences
Summary
The mean change in fasting plasma glucose from baseline to week 32 (CagriSema: -3·3 mmol/L [SE 0·3]; semaglutide: -2·5 mmol/L [0·4]; cagrilintide: -1·7 mmol/L [0·3]) was greater with CagriSema versus cagrilintide (p=0·0010) but not versus semaglutide (p=0·10).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459009
35HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, time in range (3.9-10.0 mmol/L) rose from 45.9% at baseline to 88.9% at week 32 with CagriSema.
In plain wordsIn adults with type 2 diabetes, time with glucose in the target range rose from 45.9% to 88.9% with CagriSema.
Peptide
Cagrilintide
Outcome
IncreaseCGM time in range, CagriSema
Study
n: not reported in source
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Time in range
88.9%
CagriSema, week 32
Time in range
45.9%
CagriSema, baseline
Source sentences
Summary
Time in range (3·9-10·0 mmol/L) was 45·9%, 32·6%, and 56·9% at baseline and 88·9%, 76·2%, and 71·7% at week 32 with CagriSema, semaglutide, and cagrilintide, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes and a BMI of 27 kg/m² or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
In this study, Cagrilintide 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 Cagrilintide.
Report a problemFND-3736459011

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT04982575

Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

Novo Nordisk A/Sn = 922 Aug 2021 to 7 Jul 2022

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 23 Dec 2025

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