Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial.

Yamauchi T, Becker NP, Hagemann CA, Huang KC, Kiyosue A, Lim S, Onishi Y, Kosuvaripalli A, Takano T, Ishigaki Y

The lancet. Diabetes & endocrinology17 Apr 2026Cited by 1 (Europe PMC)

PMID42009015DOI10.1016/s2213-8587(25)00402-4PepBankPUB-42009015

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 study13

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

01HumanRandomized controlled trialEfficacy outcome
In east Asian adults with overweight or obesity, cagrilintide-semaglutide reduced bodyweight more than semaglutide alone at week 68.
In plain wordsIn east Asian adults with overweight or obesity, the combination led to more weight loss than semaglutide alone.
Peptide
Cagrilintide
Outcome
DecreaseRelative change in bodyweight from baseline to week 68
Study
n = 331
Comparator
Semaglutide 2·4 mg
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
cagrilintide 2·4 mg plus semaglutide 2·4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Relative bodyweight change
−18.4%
cagrilintide-semaglutide
Relative bodyweight change
−11.9%
semaglutide
Estimated treatment difference
−6.5 percentage points
cagrilintide-semaglutide vs semaglutide
Source sentences
Summary
The estimated mean change in bodyweight from baseline to week 68 was -18·4% (SE 0·7) in the cagrilintide-semaglutide group versus -11·9% (0·7) in the semaglutide group (estimated treatment difference [ETD] -6·5 percentage points [95% CI -8·4 to -4·6]; p<0·0001).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was relative change in bodyweight from baseline to week 68.
Summary · context
We assessed the efficacy and safety of a fixed-dose combination of cagrilintide 2·4 mg and semaglutide 2·4 mg versus semaglutide 2·4 mg for weight management in an east Asian population.
Report a problemFND-4200901501
02HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity in Japan and Taiwan, semaglutide 2.4 mg lowered bodyweight by a mean of 11.9% at week 68.
In plain wordsIn adults with overweight or obesity in Japan and Taiwan, semaglutide 2.4 mg led to a mean weight loss of 11.9% over 68 weeks.
Peptide
Semaglutide
Outcome
DecreaseRelative change in bodyweight from baseline to week 68
Study
n = 167
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Mean weight change
−11.9%
semaglutide 2.4 mg
Source sentences
Summary
The estimated mean change in bodyweight from baseline to week 68 was -18·4% (SE 0·7) in the cagrilintide-semaglutide group versus -11·9% (0·7) in the semaglutide group (estimated treatment difference [ETD] -6·5 percentage points [95% CI -8·4 to -4·6]; p<0·0001).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was relative change in bodyweight from baseline to week 68.
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
Report a problemFND-4200901506
03HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, adverse events were reported by 84% of participants given semaglutide 2.4 mg.
In plain wordsIn adults with overweight or obesity, 84% of people on semaglutide 2.4 mg reported side effects.
Peptide
Semaglutide
Outcome
Not applicableAdverse events
Study
n = 167
Comparator
Cagrilintide-semaglutide
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Participants with adverse events
141 participants
semaglutide
Proportion
84%
semaglutide
Source sentences
Summary
Adverse events were reported by 143 (87%) of 164 participants in the cagrilintide-semaglutide group and 141 (84%) of 167 in the semaglutide group, the most common of which were gastrointestinal disorders (87 [53%] of 164 participants in the cagrilintide-semaglutide group vs 85 [51%] of 167 in the semaglutide group).
2 context sentences(design, population, supporting numbers)
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
Report a problemFND-4200901508
04HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, gastrointestinal disorders were reported by 51% of participants given semaglutide 2.4 mg.
In plain wordsIn adults with overweight or obesity, 51% of people on semaglutide 2.4 mg had stomach or gut side effects.
Peptide
Semaglutide
Outcome
Not applicableGastrointestinal disorders
Study
n = 167
Comparator
Cagrilintide-semaglutide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Participants with GI disorders
85 participants
semaglutide
Proportion
51%
semaglutide
Source sentences
Summary
Adverse events were reported by 143 (87%) of 164 participants in the cagrilintide-semaglutide group and 141 (84%) of 167 in the semaglutide group, the most common of which were gastrointestinal disorders (87 [53%] of 164 participants in the cagrilintide-semaglutide group vs 85 [51%] of 167 in the semaglutide group).
2 context sentences(design, population, supporting numbers)
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
Report a problemFND-4200901510
05HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, 6% of participants discontinued semaglutide 2.4 mg.
In plain wordsIn adults with overweight or obesity, 6% of people stopped semaglutide 2.4 mg.
Peptide
Semaglutide
Outcome
Not applicableTreatment discontinuation
Study
n = 167
Comparator
Cagrilintide-semaglutide
Outcome group
Adverse events · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Participants who discontinued
10 participants
semaglutide
Proportion
6%
semaglutide
Source sentences
Summary
17 (10%) participants discontinued cagrilintide-semaglutide and ten (6%) discontinued semaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
Report a problemFND-4200901512
06HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, one death occurred in the semaglutide 2.4 mg group; the investigator judged it not treatment related.
In plain wordsIn adults with overweight or obesity, one person died in the semaglutide 2.4 mg group; the investigator judged the death unrelated to treatment.
Peptide
Semaglutide
Outcome
Not applicableDeaths
Study
n = 167
Comparator
Cagrilintide-semaglutide
Outcome group
Mortality · Whole body
Studied dose
2.4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Deaths
1 participant
semaglutide 2.4 mg
Source sentences
Summary
One death was reported in the semaglutide 2·4 mg group, which was not judged to be treatment related by the investigator.
2 context sentences(design, population, supporting numbers)
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
Report a problemFND-4200901513
07HumanRandomized controlled trialSafety outcome
In east Asian adults with overweight or obesity, 17 participants (10%) discontinued cagrilintide-semaglutide and ten (6%) discontinued semaglutide.
In plain wordsIn east Asian adults with overweight or obesity, 10% stopped the combination and 6% stopped semaglutide alone.
Peptide
Cagrilintide
Outcome
Direction not reportedTreatment discontinuation
Study
n: not reported in source
Comparator
Semaglutide 2·4 mg
Outcome group
Adverse events · Whole body
Studied dose
cagrilintide 2·4 mg plus semaglutide 2·4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Participants discontinuing
10%
cagrilintide-semaglutide
Participants discontinuing
6%
semaglutide
Source sentences
Summary
17 (10%) participants discontinued cagrilintide-semaglutide and ten (6%) discontinued semaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of a fixed-dose combination of cagrilintide 2·4 mg and semaglutide 2·4 mg versus semaglutide 2·4 mg for weight management in an east Asian population.
Report a problemFND-4200901502
08HumanRandomized controlled trialSafety outcome
In east Asian adults with overweight or obesity, adverse events were reported by 143 of 164 participants on cagrilintide-semaglutide and 141 of 167 on semaglutide.
In plain wordsIn east Asian adults with overweight or obesity, 87% on the combination and 84% on semaglutide alone had side effects.
Peptide
Cagrilintide
Outcome
Direction not reportedAdverse events
Study
n: not reported in source
Comparator
Semaglutide 2·4 mg
Outcome group
Adverse events · Whole body
Studied dose
cagrilintide 2·4 mg plus semaglutide 2·4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Participants with adverse events
87%
cagrilintide-semaglutide
Participants with adverse events
84%
semaglutide
Source sentences
Summary
Adverse events were reported by 143 (87%) of 164 participants in the cagrilintide-semaglutide group and 141 (84%) of 167 in the semaglutide group,
1 context sentence(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of a fixed-dose combination of cagrilintide 2·4 mg and semaglutide 2·4 mg versus semaglutide 2·4 mg for weight management in an east Asian population.
Report a problemFND-4200901503
09HumanRandomized controlled trialSafety outcome
In east Asian adults with overweight or obesity, gastrointestinal disorders were the most common adverse events: 87 of 164 participants on cagrilintide-semaglutide and 85 of 167 on semaglutide.
In plain wordsIn east Asian adults with overweight or obesity, stomach and bowel problems affected 53% on the combination and 51% on semaglutide alone.
Peptide
Cagrilintide
Outcome
Direction not reportedGastrointestinal disorders
Study
n: not reported in source
Comparator
Semaglutide 2·4 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
cagrilintide 2·4 mg plus semaglutide 2·4 mg once weekly · subcutaneous · 68 weeksAs given in this study (human).
Measurements
Participants with gastrointestinal disorders
53%
cagrilintide-semaglutide
Participants with gastrointestinal disorders
51%
semaglutide
Source sentences
Summary
the most common of which were gastrointestinal disorders (87 [53%] of 164 participants in the cagrilintide-semaglutide group vs 85 [51%] of 167 in the semaglutide group).
1 context sentence(design, population, supporting numbers)
Summary · context
We assessed the efficacy and safety of a fixed-dose combination of cagrilintide 2·4 mg and semaglutide 2·4 mg versus semaglutide 2·4 mg for weight management in an east Asian population.
Report a problemFND-4200901504

Studies that did not test the peptide alone4

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.

10HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with overweight or obesity in Japan and Taiwan, fixed-dose cagrilintide-semaglutide reduced bodyweight more than semaglutide alone at week 68.
In plain wordsIn adults with overweight or obesity in Japan and Taiwan, the cagrilintide-semaglutide combination led to more weight loss than semaglutide alone.
Peptide
Semaglutide
Outcome
DecreaseRelative change in bodyweight from baseline to week 68
Study
n = 331
Comparator
Semaglutide 2.4 mg
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Measurements
Mean weight change
−18.4%
cagrilintide-semaglutide
Estimated treatment difference
−6.5 percentage points
vs semaglutide
Source sentences
Summary
The estimated mean change in bodyweight from baseline to week 68 was -18·4% (SE 0·7) in the cagrilintide-semaglutide group versus -11·9% (0·7) in the semaglutide group (estimated treatment difference [ETD] -6·5 percentage points [95% CI -8·4 to -4·6]; p<0·0001).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was relative change in bodyweight from baseline to week 68.
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
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-4200901505
11HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with overweight or obesity, adverse events were reported by 87% of participants given cagrilintide-semaglutide.
In plain wordsIn adults with overweight or obesity, 87% of people on the cagrilintide-semaglutide combination reported side effects, against 84% on semaglutide alone.
Peptide
Semaglutide
Outcome
Not applicableAdverse events
Study
n = 164
Comparator
Semaglutide 2.4 mg
Outcome group
Adverse events · Whole body
Measurements
Participants with adverse events
143 participants
cagrilintide-semaglutide
Proportion
87%
cagrilintide-semaglutide
Source sentences
Summary
Adverse events were reported by 143 (87%) of 164 participants in the cagrilintide-semaglutide group and 141 (84%) of 167 in the semaglutide group, the most common of which were gastrointestinal disorders (87 [53%] of 164 participants in the cagrilintide-semaglutide group vs 85 [51%] of 167 in the semaglutide group).
2 context sentences(design, population, supporting numbers)
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
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-4200901507
12HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with overweight or obesity, gastrointestinal disorders were reported by 53% of participants given cagrilintide-semaglutide.
In plain wordsIn adults with overweight or obesity, 53% of people on the cagrilintide-semaglutide combination had stomach or gut side effects, against 51% on semaglutide alone.
Peptide
Semaglutide
Outcome
Not applicableGastrointestinal disorders
Study
n = 164
Comparator
Semaglutide 2.4 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Participants with GI disorders
87 participants
cagrilintide-semaglutide
Proportion
53%
cagrilintide-semaglutide
Source sentences
Summary
Adverse events were reported by 143 (87%) of 164 participants in the cagrilintide-semaglutide group and 141 (84%) of 167 in the semaglutide group, the most common of which were gastrointestinal disorders (87 [53%] of 164 participants in the cagrilintide-semaglutide group vs 85 [51%] of 167 in the semaglutide group).
2 context sentences(design, population, supporting numbers)
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
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-4200901509
13HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with overweight or obesity, 10% of participants discontinued cagrilintide-semaglutide.
In plain wordsIn adults with overweight or obesity, 10% of people stopped the cagrilintide-semaglutide combination, against 6% on semaglutide alone.
Peptide
Semaglutide
Outcome
Not applicableTreatment discontinuation
Study
n = 164
Comparator
Semaglutide 2.4 mg
Outcome group
Adverse events · Whole body
Measurements
Participants who discontinued
17 participants
cagrilintide-semaglutide
Proportion
10%
cagrilintide-semaglutide
Source sentences
Summary
17 (10%) participants discontinued cagrilintide-semaglutide and ten (6%) discontinued semaglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
We included participants aged at least 18 years with a BMI of at least 27 kg/m² and at least two obesity-related complications, or with a BMI of at least 35 kg/m² and at least one obesity-related complication (per the Japan Society for the Study of Obesity guidelines), with or…
Summary · context
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
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-4200901511

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 3NCT05813925

A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

Novo Nordisk A/Sn = 3313 Apr 2023 to 7 Mar 2025

Obesity or Overweight

Trial page ClinicalTrials.govUpdated 22 Jan 2026

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