Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study.

Rosenstock J, Billings LK, Gajria R, Giorgino F, Johansen NB, Klein KR, Thamattoor UK, Buse JB, Jain AB

Lancet (London, England)7 Jun 2026Cited by 5 (Europe PMC)

PMID42251856DOI10.1016/s0140-6736(26)01022-6PepBankPUB-42251856

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 study14

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

Studies that did not test the peptide alone14

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 basal insulin, CagriSema (cagrilintide-semaglutide 1·0 mg each) lowered HbA1c more than placebo at week 40 (difference -1·44 percentage points).
In plain wordsIn adults with type 2 diabetes on basal insulin, 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 = 93
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c treatment difference
−1.44 percentage points
1.0 mg each vs placebo
Source sentences
Summary
for cagrilintide-semaglutide [1·0 mg each] vs placebo -1·44 percentage points [95% CI -1·71 to -1·17], p<0·0001
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes (glycated haemoglobin [HbA_1c] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin
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-4225185609
02HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, CagriSema (cagrilintide-semaglutide 2·4 mg each) lowered HbA1c more than placebo at week 40 (difference -1·68 percentage points).
In plain wordsIn adults with type 2 diabetes on basal insulin, 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 = 90
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c treatment difference
−1.68 percentage points
2.4 mg each vs placebo
Source sentences
Summary
estimated treatment difference for cagrilintide-semaglutide [2·4 mg each] vs placebo -1·68 percentage points [95% CI -1·95 to -1·41], p<0·0001
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes (glycated haemoglobin [HbA_1c] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin
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-4225185608
03HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, cagrilintide-semaglutide 2·4 mg each lowered HbA1c more than placebo at week 40 (estimated difference -1·68 percentage points).
In plain wordsIn adults with type 2 diabetes on basal insulin, 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
−2.33%
2·4 mg each
Estimated treatment difference vs placebo
−1.68 percentage points
2·4 mg each
Source sentences
Summary
Mean HbA_1c reductions were significantly greater with cagrilintide-semaglutide (2·4 mg each -2·33% [SE 0·08] and 1·0 mg each -2·10% [0·08]) versus placebo (-0·66% [0·11]) at week 40, using the efficacy estimand (estimated treatment difference for cagrilintide-semaglutide [2·4 mg each] vs…
1 context sentence(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
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-4225185601
04HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, cagrilintide-semaglutide 1·0 mg each lowered HbA1c more than placebo at week 40 (estimated difference -1·44 percentage points).
In plain wordsIn adults with type 2 diabetes on basal insulin, 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
−2.1%
1·0 mg each
Estimated treatment difference vs placebo
−1.44 percentage points
1·0 mg each
Source sentences
Summary
Mean HbA_1c reductions were significantly greater with cagrilintide-semaglutide (2·4 mg each -2·33% [SE 0·08] and 1·0 mg each -2·10% [0·08]) versus placebo (-0·66% [0·11]) at week 40
2 context sentences(design, population, supporting numbers)
Summary · context
for cagrilintide-semaglutide [1·0 mg each] vs placebo -1·44 percentage points [95% CI -1·71 to -1·17], p<0·0001).
Summary · context
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
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-4225185602
05HumanNot a test of Cagrilintide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, cagrilintide-semaglutide provided bodyweight reductions of 10-12%.
In plain wordsIn adults with type 2 diabetes on basal insulin, cagrilintide-semaglutide was linked to body weight falls of 10-12%.
Peptide
Cagrilintide
Outcome
DecreaseBodyweight reduction
Study
n: not reported in source
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Bodyweight reduction
10 to 12%
cagrilintide-semaglutide
Source sentences
Summary
Cagrilintide-semaglutide provided bodyweight reductions of 10-12%.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was mean HbA_1c change (percentage points) from baseline to week 40 in all participants randomly assigned to treatment; secondary endpoints included change in bodyweight and safety, including hypoglycaemia.
Summary · context
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
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-4225185603
06HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on basal insulin, CagriSema (cagrilintide-semaglutide) gave bodyweight reductions of 10-12%.
In plain wordsIn adults with type 2 diabetes on basal insulin, the CagriSema combination reduced body weight by 10 to 12 percent.
Peptide
Semaglutide
Outcome
DecreaseBodyweight reduction
Study
n: not reported in source
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Bodyweight reduction
10 to 12%
cagrilintide-semaglutide
Source sentences
Summary
Cagrilintide-semaglutide provided bodyweight reductions of 10-12%.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes (glycated haemoglobin [HbA_1c] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin
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-4225185610
07HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, no severe hypoglycaemia was reported with CagriSema.
In plain wordsIn adults with type 2 diabetes on basal insulin, no severe low blood sugar was reported with the CagriSema combination.
Peptide
Semaglutide
Outcome
No significant changeSevere hypoglycaemia
Study
n = 274
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
No severe hypoglycaemia was reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes (glycated haemoglobin [HbA_1c] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin
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-4225185613
08HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, one death occurred in the CagriSema 1·0 mg each group, not related to treatment (malignancy).
In plain wordsIn adults with type 2 diabetes on basal insulin, one person on the lower-dose CagriSema combination died. The death was not related to treatment.
Peptide
Semaglutide
Outcome
Not applicableDeath
Study
n = 274
Comparator
Placebo
Outcome group
Mortality · Metabolic and weight
Source sentences
Summary
There was one death in the cagrilintide-semaglutide (1·0 mg each) group not related to treatment (due to malignancy).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes (glycated haemoglobin [HbA_1c] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin
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-4225185614
09HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, 71% of participants on CagriSema (1·0 mg each) reported adverse events, the same as 71% on placebo.
In plain wordsIn adults with type 2 diabetes on basal insulin, 71% on the lower-dose CagriSema combination had side effects, the same share as on placebo.
Peptide
Semaglutide
Outcome
Direction not reportedAdverse events (1·0 mg each)
Study
n = 93
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Measurements
Participants with adverse events
71%
1.0 mg each
Source sentences
Summary
Adverse events were reported by 72 (80%) of 90 participants receiving cagrilintide-semaglutide (2·4 mg each), 66 (71%) of 93 receiving cagrilintide-semaglutide (1·0 mg each), and 65 (71%) of 91 receiving placebo, and were mostly mild or moderate gastrointestinal disorders.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes (glycated haemoglobin [HbA_1c] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin
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-4225185612
10HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, 80% of participants on CagriSema (2·4 mg each) reported adverse events, versus 71% on placebo; most were mild or moderate gastrointestinal disorders.
In plain wordsIn adults with type 2 diabetes on basal insulin, 80% on the CagriSema combination had side effects, against 71% on placebo. Most were mild.
Peptide
Semaglutide
Outcome
Direction not reportedAdverse events (2·4 mg each)
Study
n = 90
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Measurements
Participants with adverse events
80%
2.4 mg each
Source sentences
Summary
Adverse events were reported by 72 (80%) of 90 participants receiving cagrilintide-semaglutide (2·4 mg each), 66 (71%) of 93 receiving cagrilintide-semaglutide (1·0 mg each), and 65 (71%) of 91 receiving placebo, and were mostly mild or moderate gastrointestinal disorders.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with type 2 diabetes (glycated haemoglobin [HbA_1c] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin
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-4225185611
11HumanNot a test of Cagrilintide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, adverse events occurred in 72 of 90 participants on cagrilintide-semaglutide 2·4 mg each versus 65 of 91 on placebo, mostly mild or moderate gastrointestinal disorders.
In plain wordsIn adults with type 2 diabetes on basal insulin, 80% on the 2·4 mg combination and 71% 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
80%
2·4 mg each
Participants with adverse events
71%
placebo
Source sentences
Summary
Adverse events were reported by 72 (80%) of 90 participants receiving cagrilintide-semaglutide (2·4 mg each), 66 (71%) of 93 receiving cagrilintide-semaglutide (1·0 mg each), and 65 (71%) of 91 receiving placebo, and were mostly mild or moderate gastrointestinal disorders.
1 context sentence(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
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-4225185604
12HumanNot a test of Cagrilintide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, adverse events occurred in 66 of 93 participants on cagrilintide-semaglutide 1·0 mg each versus 65 of 91 on placebo, mostly mild or moderate gastrointestinal disorders.
In plain wordsIn adults with type 2 diabetes on basal insulin, 71% on the 1·0 mg combination had side effects, the same as 71% on placebo.
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
71%
1·0 mg each
Participants with adverse events
71%
placebo
Source sentences
Summary
Adverse events were reported by 72 (80%) of 90 participants receiving cagrilintide-semaglutide (2·4 mg each), 66 (71%) of 93 receiving cagrilintide-semaglutide (1·0 mg each), and 65 (71%) of 91 receiving placebo, and were mostly mild or moderate gastrointestinal disorders.
1 context sentence(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
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-4225185605
13HumanNot a test of Cagrilintide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, no severe hypoglycaemia was reported.
In plain wordsIn adults with type 2 diabetes on basal insulin, no severe low blood sugar was reported.
Peptide
Cagrilintide
Outcome
No significant changeSevere hypoglycaemia
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
No severe hypoglycaemia was reported.
1 context sentence(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
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-4225185606
14HumanNot a test of Cagrilintide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes on basal insulin, one death occurred in the cagrilintide-semaglutide 1·0 mg each group, not related to treatment (malignancy).
In plain wordsIn adults with type 2 diabetes on basal insulin, one person in the 1·0 mg group died of cancer, not related to treatment.
Peptide
Cagrilintide
Outcome
Direction not reportedDeath in the 1·0 mg each group
Study
n: not reported in source
Outcome group
Mortality · Whole body
Source sentences
Summary
There was one death in the cagrilintide-semaglutide (1·0 mg each) group not related to treatment (due to malignancy).
1 context sentence(design, population, supporting numbers)
Summary · context
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
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-4225185607

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 3NCT06323161

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 Once-daily Basal Insulin With or Without Metformin

Novo Nordisk A/Sn = 27426 Mar 2024 to 23 Oct 2025

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 9 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