Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial.

Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietiläinen KH, Rubino D, Batterham RL

Lancet (London, England)16 Nov 2021Cited by 208 (Europe PMC)

PMID34798060DOI10.1016/s0140-6736(21)01751-7PepBankPUB-34798060

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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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, all doses of cagrilintide (0.3-4.5 mg) reduced bodyweight more than placebo at week 26 (6.0%-10.8% vs 3.0%; p<0.001).
In plain wordsIn adults with overweight or obesity, every cagrilintide dose led to more weight loss than placebo after 26 weeks.
Peptide
Cagrilintide
Outcome
DecreasePercentage bodyweight change at week 26 (trial product estimand)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.3-4.5 mg · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Bodyweight change
6 to 10.8%
cagrilintide 0.3-4.5 mg
Bodyweight change
3%
placebo
p
< 0.001
vs placebo
Source sentences
Summary
According to the trial product estimand, mean percentage weight reductions from baseline were greater with all doses of cagrilintide (0·3-4·5 mg, 6·0%-10·8% [6·4-11·5 kg]) versus placebo (3·0% [3·3 kg]; estimated treatment difference range 3·0%-7·8%; p<0·001).
4 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the percentage change in bodyweight from baseline to week 26, assessed in all randomly assigned participants according to the trial product estimand (assuming all participants were adherent to treatment) and to the treatment policy estimand (regardless of adherence to treatment).
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806001
02HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, similar weight reductions with cagrilintide were seen under the treatment policy estimand.
In plain wordsIn adults with overweight or obesity, weight loss with cagrilintide was similar when all participants were counted, whether or not they stayed on treatment.
Peptide
Cagrilintide
Outcome
DecreasePercentage bodyweight change at week 26 (treatment policy estimand)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.3-4.5 mg · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
Similar weight loss reductions were observed with the treatment policy estimand.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806002
03HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, once-daily liraglutide 3.0 mg reduced body weight by 9.0% at week 26, less than cagrilintide 4.5 mg (10.8%).
In plain wordsIn adults with overweight or obesity, liraglutide reduced body weight by 9.0%, less than the 10.8% loss with cagrilintide 4.5 mg.
Peptide
Liraglutide
Outcome
DecreaseBody weight change at week 26 (trial product estimand)
Study
n = 99
Comparator
Cagrilintide 4.5 mg
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg once daily · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Weight reduction from baseline
9%
liraglutide 3.0 mg, trial product estimand
Source sentences
Summary
Weight reductions were also greater with cagrilintide 4·5 mg versus liraglutide 3·0 mg (10·8% [11·5 kg] vs 9·0% [9·6 kg]; estimated treatment difference 1·8%, p=0·03).
2 context sentences(design, population, supporting numbers)
Summary · context
once-daily liraglutide 3·0 mg
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Report a problemFND-3479806009
04HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, cagrilintide 4.5 mg reduced bodyweight more than liraglutide 3.0 mg at week 26 (10.8% vs 9.0%; p=0.03).
In plain wordsIn adults with overweight or obesity, cagrilintide 4.5 mg led to more weight loss than liraglutide 3.0 mg after 26 weeks.
Peptide
Cagrilintide
Outcome
DecreasePercentage bodyweight change at week 26, cagrilintide 4.5 mg vs liraglutide
Study
n: not reported in source
Comparator
Liraglutide 3.0 mg
Outcome group
Body weight · Metabolic and weight
Studied dose
4.5 mg · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Bodyweight change
10.8%
cagrilintide 4.5 mg
Bodyweight change
9%
liraglutide 3.0 mg
p
0.03
vs liraglutide
Source sentences
Summary
Weight reductions were also greater with cagrilintide 4·5 mg versus liraglutide 3·0 mg (10·8% [11·5 kg] vs 9·0% [9·6 kg]; estimated treatment difference 1·8%, p=0·03).
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806003
05HumanRandomized controlled trialSafety outcome
Permanent treatment discontinuation (10%) occurred similarly across treatment groups, mostly due to adverse events (4%).
In plain wordsIn adults with overweight or obesity, about 1 in 10 stopped treatment for good, at similar rates in all groups, mostly because of side effects.
Peptide
Cagrilintide
Outcome
No significant changePermanent treatment discontinuation
Study
n: not reported in source
Comparator
Placebo and liraglutide
Outcome group
Adverse events · Whole body
Studied dose
0.3-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Permanent discontinuation
10%
all groups
Discontinuation due to adverse events
4%
all groups
Source sentences
Summary
Permanent treatment discontinuation (n=73 [10%]) occurred similarly across treatment groups, mostly due to adverse events (n=30 [4%]).
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806004
06HumanRandomized controlled trialSafety outcome
In total, 29 participants (4%) withdrew from the trial.
In plain wordsIn adults with overweight or obesity, 29 participants (4%) left the trial before the end.
Peptide
Cagrilintide
Outcome
Not applicableWithdrawal from the trial
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Participants who withdrew
29 participants
all groups
Source sentences
Summary
In total, 29 participants (4%) withdrew from the trial.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806005
07HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, more participants receiving cagrilintide 0.3-4.5 mg had gastrointestinal adverse events than with placebo (41%-63% vs 32%).
In plain wordsIn adults with overweight or obesity, more people on cagrilintide had stomach and gut side effects than on placebo.
Peptide
Cagrilintide
Outcome
IncreaseGastrointestinal adverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.3-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Gastrointestinal adverse events
41 to 63%
cagrilintide 0.3-4.5 mg
Gastrointestinal adverse events
32%
placebo
Source sentences
Summary
More participants receiving cagrilintide 0·3-4·5 mg had gastrointestinal adverse events compared with placebo (41%-63% vs 32%), primarily nausea (20%-47% vs 18%).
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806006
08HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, nausea was more frequent with cagrilintide 0.3-4.5 mg than with placebo (20%-47% vs 18%).
In plain wordsIn adults with overweight or obesity, nausea was more common on cagrilintide than on placebo.
Peptide
Cagrilintide
Outcome
IncreaseNausea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.3-4.5 mg · subcutaneousAs given in this study (human).
Measurements
Nausea
20 to 47%
cagrilintide 0.3-4.5 mg
Nausea
18%
placebo
Source sentences
Summary
primarily nausea (20%-47% vs 18%).
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806007
09HumanRandomized controlled trialSafety outcome
The most frequent adverse events were gastrointestinal disorders (for example nausea, constipation and diarrhoea) and administration-site reactions.
In plain wordsIn adults with overweight or obesity, the most common side effects were stomach and gut problems and reactions where the injection was given.
Peptide
Cagrilintide
Outcome
Not applicableConstipation, diarrhoea and administration-site reactions
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.3-4.5 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
The most frequent adverse events were gastrointestinal disorders (eg, nausea, constipation, and diarrhoea) and administration-site reactions.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible participants were adults aged at least 18 years without diabetes, with a body-mass index of at least 30 kg/m² or at least 27 kg/m² with hypertension or dyslipidaemia.
Summary · context
Participants were randomly assigned (6:1) to subcutaneous self-injections of once-weekly cagrilintide (0·3, 0·6, 1·2, 2·4, or 4·5 mg), once-daily liraglutide 3·0 mg, or volume-matched placebo (for six placebo groups).
Summary · context
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Report a problemFND-3479806008

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 postedNCT03856047

Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

Novo Nordisk A/Sn = 7061 Mar 2019 to 25 Mar 2021

Overweight · Obesity

Trial page ClinicalTrials.govUpdated 5 Jul 2024

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, 03:05 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC