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Cagrilintide

Clinical — 9 studies

Cagrilintide, a lipidated amylin analogue with a long duration of action, was developed for clinical study in obesity. Most of the trials cited here test it together with semaglutide in adults with overweight, obesity or type 2 diabetes.

Updated

Being studied for

  • Amylin analogue medicinal chemistry
  • Obesity clinical trials
  • Type 2 diabetes clinical trials
  • Blood pressure secondary analyses

What the research shows

The cited work on cagrilintide dates from 2021 to 2026 and is mostly clinical. A 2021 medicinal chemistry paper describes its development, and a 2021 phase 2 dose-finding trial tested it alone over 26 weeks in people with overweight or obesity without diabetes, against placebo and liraglutide. The remaining trials tested it together with semaglutide: a 68-week phase 3 trial in adults with overweight or obesity, REDEFINE 5 in adults in Japan and Taiwan, a phase 3 trial in adults with obesity and type 2 diabetes, a phase 2 trial and two phase 3 trials (REIMAGINE 2 and REIMAGINE 3) in type 2 diabetes, and a post hoc blood pressure analysis of REDEFINE 1.

The phase 2 trial reported significant reductions in body weight with cagrilintide alone and described it as well tolerated. Among the combination trials, the 68-week phase 3 study reported significant reductions in body weight compared with placebo, and the trial in adults with obesity and type 2 diabetes reported lower body weight than placebo. REIMAGINE 3 reported reductions in HbA1c against placebo when the combination was added to basal insulin, with no added risk of hypoglycaemia. The phase 2 diabetes trial measured glycaemic control, including continuous glucose monitoring, against each component, and REIMAGINE 2 made the same comparison in people taking metformin, describing a safety profile in line with the GLP-1 receptor agonist class and earlier cagrilintide data. The REDEFINE 1 analysis reported lower blood pressure across participant subgroups, including people with resistant hypertension. The chemistry paper sets out the structure-activity work that led to cagrilintide's selection for clinical development.

Most of this evidence describes the combination with semaglutide rather than cagrilintide alone. Only the phase 2 dose-finding trial isolates it, and a dose-finding study is not a confirmatory trial. Most of the combination trials were published in 2025 or 2026, the blood pressure results come from a post hoc analysis rather than a primary endpoint, and each trial's findings apply to the population it enrolled, defined by body weight, diabetes status or background treatment.

Published Research

Evidence profile

Human Phase 3 evidence

9 cited publications · 7 primary trials · 1 derived analysis

Findings below belong to the studies that reported them. They describe the material and conditions those authors used, not this product, and not an outcome to expect.

Core evidence

The publications most central to understanding this compound.

ClinicalPhase 3 randomised, double-blind, placebo-controlled trial

REDEFINE 1

Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity

Garvey WT et al. · The New England journal of medicine · 2025

Population: Adults with overweight and a coexisting condition, or obesity

The Phase 3 trial of cagrilintide coadministered with semaglutide, with relative change in body weight and the proportion reaching a 5% reduction at week 68 as coprimary endpoints.

As reported by the study

Route reported
Subcutaneous
Schedule
Once weekly under the trial protocol
Duration
68 weeks

Context: Studies the combination, not cagrilintide alone. Findings belong to the coadministered regimen described by the authors.

PMID 40544433DOI 10.1056/NEJMoa2502081NCT05567796View on PubMed
ClinicalPhase 2 randomised, double-blind, placebo- and active-controlled dose-finding trial

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 et al. · Lancet (London, England) · 2021

Population: People with overweight or obesity, without diabetes

The dose-finding study of cagrilintide as monotherapy, comparing several doses against both placebo and liraglutide 3.0 mg over 26 weeks.

As reported by the study

Route reported
Subcutaneous
Schedule
Once weekly under the trial protocol
Duration
26 weeks
Treatment arms
0.3 mg · 0.6 mg · 1.2 mg · 2.4 mg · 4.5 mg · Liraglutide 3.0 mg · Placebo
Weight reduction versus placebo
“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).”
Versus liraglutide 3.0 mg
“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).”

Context: Phase 2 dose-finding, not a confirmatory efficacy trial.

PMID 34798060DOI 10.1016/S0140-6736(21)01751-7NCT03856047View on PubMed

Supporting evidence

ClinicalPrimary trial · Phase 3

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 et al. · The lancet. Diabetes & endocrinology · 2026

The study reportedThese findings support the efficacy and safety of cagrilintide-semaglutide for weight management in individuals from east Asia with overweight or obesity, with or without type 2 diabetes.

PMID 42009015DOI 10.1016/S2213-8587(25)00402-4NCT05813925View on PubMed
ClinicalPrimary trial · Phase 3

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 et al. · Lancet (London, England) · 2026

The study reportedCagrilintide-semaglutide at doses of 2·4 mg each and 1·0 mg each met the primary endpoint, with statistically significant and clinically relevant HbA1c reductions versus placebo when added to basal insulin-treated type 2 diabetes. These reductions were accompanied by robust bodyweight reduction and no additional risk of hypoglycaemia.

PMID 42251856DOI 10.1016/S0140-6736(26)01022-6NCT06323161View on PubMed
ClinicalPrimary trial · Phase 3

Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study

Buse JB et al. · The lancet. Diabetes & endocrinology · 2026

The study reportedCagrilintide-semaglutide (2·4 mg each) was superior to semaglutide 2·4 mg in reducing HbA1c in participants with type 2 diabetes receiving metformin with or without an SGLT2 inhibitor. The safety profile of cagrilintide-semaglutide was consistent with the GLP-1 receptor agonist class and previous safety data for cagrilintide.

PMID 42251859DOI 10.1016/S2213-8587(26)00125-7NCT06065540View on PubMed
ClinicalPrimary trial · Phase 3

Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

Davies MJ et al. · The New England journal of medicine · 2025

The study reportedOnce-weekly cagrilintide-semaglutide (at a dose of 2.4 mg each) resulted in a significantly lower body weight than placebo in adults with obesity and type 2 diabetes.

PMID 40544432DOI 10.1056/NEJMoa2502082NCT05394519View on PubMed
ClinicalPrimary trial · Phase 2

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 et al. · Lancet (London, England) · 2023

The study reportedIn people with type 2 diabetes, treatment with CagriSema resulted in clinically relevant improvements in glycaemic control (including CGM parameters). The mean change in HbA1c with CagriSema was greater versus cagrilintide, but not versus semaglutide.

PMID 37364590DOI 10.1016/S0140-6736(23)01163-7NCT04982575View on PubMed
PreclinicalMedicinal chemistry / molecular design

Development of Cagrilintide, a Long-Acting Amylin Analogue

Kruse T et al. · Journal of medicinal chemistry · 2021

Describes the design and molecular properties of cagrilintide as a long-acting amylin analogue, including the modifications intended to extend its duration of action.

Context: Chemistry and preclinical characterisation; not a clinical study.

PMID 34288673DOI 10.1021/acs.jmedchem.1c00565View on PubMed
Additional indexed literature (1)

Published studies summarised here concern the specific investigational or pharmaceutical materials and study conditions described by their authors. Their findings are not performance claims for Cobalt Peptides material. Citations verified against PubMed on 2026-09-29.

The studies summarised here are research reports; nothing on this page is guidance on use in people or animals.

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