Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study.

Aroda VR, Buzzetti R, Dalskov SM, Jain AB, Larsen JH, Mathieu C, Pratley RE, Videmark A, Watt T, Buse JB

The lancet. Diabetes & endocrinology7 Jun 2026Cited by 2 (Europe PMC)

PMID42251860DOI10.1016/s2213-8587(26)00126-9PepBankPUB-42251860

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

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone13

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.

01HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on diet and exercise, CagriSema (cagrilintide-semaglutide 1·0 mg each) lowered HbA1c by 1·3 percentage points more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes on diet and exercise, the lower-dose CagriSema combination lowered HbA1c more than placebo. Semaglutide was not tested alone.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 40 (1·0 mg each)
Study
n = 63
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c treatment difference
−1.3 percentage points
1.0 mg each vs placebo
Source sentences
Summary
-1·3 percentage points (-1·8 to -0·9; p<0·0001) for cagrilintide-semaglutide (1·0 mg each) versus placebo
1 context sentence(design, population, supporting numbers)
Summary · context
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise
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-4225186008
02HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on diet and exercise, CagriSema (cagrilintide-semaglutide 2·4 mg each) lowered HbA1c by 1·7 percentage points more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes on diet and exercise, the CagriSema combination lowered HbA1c more than placebo. Semaglutide was not tested alone.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 40 (2·4 mg each)
Study
n = 62
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c treatment difference
−1.7 percentage points
2.4 mg each vs placebo
Source sentences
Summary
-1·7 percentage points (95% CI -2·0 to -1·3; p<0·0001) for cagrilintide-semaglutide (2·4 mg each) versus placebo
1 context sentence(design, population, supporting numbers)
Summary · context
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise
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-4225186007
03HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes inadequately controlled on diet and exercise, cagrilintide-semaglutide 2·4 mg each lowered HbA1c more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, the 2·4 mg combination lowered HbA1c more than placebo.
Peptide
Cagrilintide
Outcome
DecreaseHbA1c change from baseline to week 40, 2·4 mg each
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change
−1.8 percentage points
2·4 mg each
HbA1c change
−0.1 percentage points
placebo
Estimated treatment difference
−1.7 percentage points
2·4 mg each vs placebo
Source sentences
Summary
Using the efficacy estimand, the estimated mean change in HbA_1c after 40 weeks was -1·8 percentage points (SE 0·1) with cagrilintide-semaglutide (2·4 mg each), -1·5 percentage points (0·1) with cagrilintide-semaglutide (1·0 mg each), and -0·1 percentage points (0·2) with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This corresponded to an estimated treatment difference of -1·7 percentage points (95% CI -2·0 to -1·3; p<0·0001) for cagrilintide-semaglutide (2·4 mg each) versus placebo and
Summary · context
We aimed to assess the efficacy and safety of cagrilintide-semaglutide for people with type 2 diabetes inadequately controlled with diet and exercise.
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-4225186001
04HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes inadequately controlled on diet and exercise, cagrilintide-semaglutide 1·0 mg each lowered HbA1c more than placebo at week 40.
In plain wordsIn adults with type 2 diabetes, the 1·0 mg combination lowered HbA1c more than placebo.
Peptide
Cagrilintide
Outcome
DecreaseHbA1c change from baseline to week 40, 1·0 mg each
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change
−1.5 percentage points
1·0 mg each
HbA1c change
−0.1 percentage points
placebo
Estimated treatment difference
−1.3 percentage points
1·0 mg each vs placebo
Source sentences
Summary
Using the efficacy estimand, the estimated mean change in HbA_1c after 40 weeks was -1·8 percentage points (SE 0·1) with cagrilintide-semaglutide (2·4 mg each), -1·5 percentage points (0·1) with cagrilintide-semaglutide (1·0 mg each), and -0·1 percentage points (0·2) with placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
and -1·3 percentage points (-1·8 to -0·9; p<0·0001) for cagrilintide-semaglutide (1·0 mg each) versus placebo.
Summary · context
We aimed to assess the efficacy and safety of cagrilintide-semaglutide for people with type 2 diabetes inadequately controlled with diet and exercise.
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-4225186002
05HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on diet and exercise, CagriSema (1·0 mg each) reduced bodyweight by 11·8% versus 1·4% with placebo at week 40 (difference -10·4 percentage points).
In plain wordsIn adults with type 2 diabetes on diet and exercise, the lower-dose CagriSema combination cut body weight more than placebo over 40 weeks.
Peptide
Semaglutide
Outcome
DecreaseRelative bodyweight change at week 40 (1·0 mg each)
Study
n = 63
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Relative bodyweight change
−11.8%
1.0 mg each
Treatment difference
−10.4 percentage points
1.0 mg each vs placebo
Source sentences
Summary
cagrilintide-semaglutide (1·0 mg each; -11·8% [1·0]) versus placebo (-1·4% [0·7]; estimated treatment difference -10·4 percentage points [-12·9 to -8·0]; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise
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-4225186010
06HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on diet and exercise, CagriSema (2·4 mg each) reduced bodyweight by 13·8% versus 1·4% with placebo at week 40 (difference -12·4 percentage points).
In plain wordsIn adults with type 2 diabetes on diet and exercise, the CagriSema combination cut body weight more than placebo over 40 weeks.
Peptide
Semaglutide
Outcome
DecreaseRelative bodyweight change at week 40 (2·4 mg each)
Study
n = 62
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Relative bodyweight change
−13.8%
2.4 mg each
Treatment difference
−12.4 percentage points
2.4 mg each vs placebo
Source sentences
Summary
cagrilintide-semaglutide (2·4 mg each; -13·8% [SE 1·0]) versus placebo (-1·4% [0·7]; estimated treatment difference -12·4 percentage points [95% CI -14·7 to -10·1]; p<0·0001)
1 context sentence(design, population, supporting numbers)
Summary · context
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise
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-4225186009
07HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, cagrilintide-semaglutide 2·4 mg each reduced bodyweight more than placebo from baseline to week 40.
In plain wordsIn adults with type 2 diabetes, the 2·4 mg combination reduced body weight more than placebo (-13·8% versus -1·4%).
Peptide
Cagrilintide
Outcome
DecreaseRelative change in bodyweight at week 40, 2·4 mg each
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Relative bodyweight change
−13.8%
2·4 mg each
Relative bodyweight change
−1.4%
placebo
Estimated treatment difference
−12.4 percentage points
2·4 mg each vs placebo
Source sentences
Summary
Cagrilintide-semaglutide was superior to placebo with respect to estimated mean relative change in bodyweight from baseline to week 40 for cagrilintide-semaglutide (2·4 mg each; -13·8% [SE 1·0]) versus placebo (-1·4% [0·7]; estimated treatment difference -12·4 percentage points [95% CI -14·7 to -10·1]; p<0·0001)
2 context sentences(design, population, supporting numbers)
Summary · context
Change in bodyweight from baseline to week 40 was a prespecified secondary endpoint.
Summary · context
We aimed to assess the efficacy and safety of cagrilintide-semaglutide for people with type 2 diabetes inadequately controlled with diet and exercise.
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-4225186003
08HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, cagrilintide-semaglutide 1·0 mg each reduced bodyweight more than placebo from baseline to week 40.
In plain wordsIn adults with type 2 diabetes, the 1·0 mg combination reduced body weight more than placebo (-11·8% versus -1·4%).
Peptide
Cagrilintide
Outcome
DecreaseRelative change in bodyweight at week 40, 1·0 mg each
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Relative bodyweight change
−11.8%
1·0 mg each
Relative bodyweight change
−1.4%
placebo
Estimated treatment difference
−10.4 percentage points
1·0 mg each vs placebo
Source sentences
Summary
and cagrilintide-semaglutide (1·0 mg each; -11·8% [1·0]) versus placebo (-1·4% [0·7]; estimated treatment difference -10·4 percentage points [-12·9 to -8·0]; p<0·0001).
2 context sentences(design, population, supporting numbers)
Summary · context
Change in bodyweight from baseline to week 40 was a prespecified secondary endpoint.
Summary · context
We aimed to assess the efficacy and safety of cagrilintide-semaglutide for people with type 2 diabetes inadequately controlled with diet and exercise.
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-4225186004
09HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on diet and exercise, most adverse events with CagriSema were mild or moderate and gastrointestinal related.
In plain wordsIn adults with type 2 diabetes on diet and exercise, most CagriSema side effects were mild or moderate and affected the stomach and gut.
Peptide
Semaglutide
Outcome
Not applicableSeverity and type of adverse events
Study
n = 125
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
Most adverse events were mild or moderate and gastrointestinal related.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise
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-4225186013
10HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on diet and exercise, 75% of participants on CagriSema (1·0 mg each) reported adverse events, versus 66% on placebo.
In plain wordsIn adults with type 2 diabetes on diet and exercise, 75% on the lower-dose CagriSema combination had side effects, against 66% on placebo.
Peptide
Semaglutide
Outcome
Direction not reportedAdverse events (1·0 mg each)
Study
n = 63
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Measurements
Participants with adverse events
75%
1.0 mg each
Source sentences
Summary
Adverse events were reported by 49 (79%) of 62 participants in the cagrilintide-semaglutide (2·4 mg each) group, 47 (75%) of 63 in the cagrilintide-semaglutide (1·0 mg each) group, and 42 (66%) of 64 in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise
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-4225186012
11HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on diet and exercise, 79% of participants on CagriSema (2·4 mg each) reported adverse events, versus 66% on placebo.
In plain wordsIn adults with type 2 diabetes on diet and exercise, 79% on the CagriSema combination had side effects, against 66% on placebo.
Peptide
Semaglutide
Outcome
Direction not reportedAdverse events (2·4 mg each)
Study
n = 62
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Measurements
Participants with adverse events
79%
2.4 mg each
Source sentences
Summary
Adverse events were reported by 49 (79%) of 62 participants in the cagrilintide-semaglutide (2·4 mg each) group, 47 (75%) of 63 in the cagrilintide-semaglutide (1·0 mg each) group, and 42 (66%) of 64 in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise
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-4225186011
12HumanNot a test of Cagrilintide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, adverse events were reported by 49 of 62 participants on cagrilintide-semaglutide 2·4 mg each and 42 of 64 on placebo; most were mild or moderate and gastrointestinal.
In plain wordsIn adults with type 2 diabetes, 79% on the 2·4 mg combination and 66% on placebo had side effects, mostly mild.
Peptide
Cagrilintide
Outcome
Direction not reportedAdverse events, 2·4 mg each
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Measurements
Participants with adverse events
79%
2·4 mg each
Participants with adverse events
66%
placebo
Source sentences
Summary
Adverse events were reported by 49 (79%) of 62 participants in the cagrilintide-semaglutide (2·4 mg each) group, 47 (75%) of 63 in the cagrilintide-semaglutide (1·0 mg each) group, and 42 (66%) of 64 in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
Most adverse events were mild or moderate and gastrointestinal related.
Summary · context
We aimed to assess the efficacy and safety of cagrilintide-semaglutide for people with type 2 diabetes inadequately controlled with diet and exercise.
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-4225186005
13HumanNot a test of Cagrilintide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, adverse events were reported by 47 of 63 participants on cagrilintide-semaglutide 1·0 mg each and 42 of 64 on placebo; most were mild or moderate and gastrointestinal.
In plain wordsIn adults with type 2 diabetes, 75% on the 1·0 mg combination and 66% on placebo had side effects, mostly mild.
Peptide
Cagrilintide
Outcome
Direction not reportedAdverse events, 1·0 mg each
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Measurements
Participants with adverse events
75%
1·0 mg each
Participants with adverse events
66%
placebo
Source sentences
Summary
Adverse events were reported by 49 (79%) of 62 participants in the cagrilintide-semaglutide (2·4 mg each) group, 47 (75%) of 63 in the cagrilintide-semaglutide (1·0 mg each) group, and 42 (66%) of 64 in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
Most adverse events were mild or moderate and gastrointestinal related.
Summary · context
We aimed to assess the efficacy and safety of cagrilintide-semaglutide for people with type 2 diabetes inadequately controlled with diet and exercise.
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-4225186006

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 3NCT06323174

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

Novo Nordisk A/Sn = 18919 Mar 2024 to 22 Dec 2025

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 30 Sept 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