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In clinical trials

Digestive & weight

CagriSema

Also called cagrilintide + semaglutide

EvidenceDeep research
ClassAmylin + GLP-1 combination

CagriSema combines cagrilintide and semaglutide in one weekly injection. See how it works, what Phase 3 trials found, and where FDA review stands today.

Reviewed by
William Maish, MD MBA MPH, Clinical Product Lead
Published
April 18, 2026
Last updated
October 5, 2026

Key takeaway

CagriSema is an investigational once-weekly injection that combines the amylin analog cagrilintide with the GLP-1 drug semaglutide, developed by Novo Nordisk for weight management and type 2 diabetes. In two large Phase 3 trials it produced substantial weight loss compared with placebo, though the headline obesity result came in below market expectations and a later head-to-head trial did not beat tirzepatide. As of 2026, it is under FDA review and not yet approved.

At a glance

FDA statusInvestigational combination peptide, not yet approved (under FDA review as of 2026)
What it isCombines cagrilintide (amylin analog) and semaglutide (GLP-1 agonist) in one weekly injection
ResearchTwo large, positive Phase 3 trials versus placebo in obesity and in type 2 diabetes
LimitationsObesity result came in below expectations; did not beat tirzepatide head-to-head
Evidence strengthDeep research

What is CagriSema?

CagriSema is an experimental fixed combination of two drugs in a single once-weekly injection: cagrilintide, a long-acting amylin analog, and semaglutide, a GLP-1 receptor agonist already used in approved diabetes and obesity products. It is being developed by Novo Nordisk for weight management and type 2 diabetes and is investigational, not yet approved.

How does it work?

CagriSema pairs two appetite-regulating mechanisms. Semaglutide activates the GLP-1 receptor1, enhancing glucose-dependent insulin release, slowing gastric emptying, and reducing appetite. Cagrilintide mimics amylin2, adding a separate satiety signal and further slowing stomach emptying and suppressing glucagon. The rationale is that combining an incretin and an amylin pathway drives complementary effects on appetite and blood sugar. This describes the intended mechanism; the trials below are what test whether it helps.

Is it FDA-approved?

No. CagriSema is investigational. According to company disclosures, Novo Nordisk submitted it to the FDA3 in the fourth quarter of 2025 for weight management, and it is under review but not approved.

What does the research show?

Two large Phase 3 trials tested CagriSema against placebo, with these results according to PubMed.

TrialPopulationMean weight change with CagriSemaMean weight change with placebo
REDEFINE 14Obesity or overweight without diabetesAbout -20% over 68 weeksAbout -3%
REDEFINE 25Obesity and type 2 diabetesAbout -14%, with most participants reaching their blood-sugar targetAbout -3%

Two caveats belong alongside those results. The REDEFINE 1 figure, while clearly positive against placebo, landed below the roughly 25% that markets had anticipated. And, a separate head-to-head trial reported by the company in 2026 (REDEFINE 4) did not meet its goal of showing CagriSema non-inferior to tirzepatide; that result has been reported via press release and is not yet peer-reviewed.

More for digestive & weight

Sources: the REDEFINE 1 trial (Garvey et al., New England Journal of Medicine, 2025, DOI: 10.1056/NEJMoa25020814) and REDEFINE 2 (Davies et al., New England Journal of Medicine, 2025, DOI: 10.1056/NEJMoa25020825), both indexed on PubMed; and Novo Nordisk filing and REDEFINE 4 announcements. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.