Digestive & weight Amylin + GLP-1 combination
CagriSema
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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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 status
- Investigational combination peptide, not yet approved (under FDA review as of 2026)
- What it is
- Combines cagrilintide (amylin analog) and semaglutide (GLP-1 agonist) in one weekly injection
- Research
- Two large, positive Phase 3 trials versus placebo in obesity and in type 2 diabetes
- Limitations
- Obesity result came in below expectations; did not beat tirzepatide head-to-head
- Evidence strength
- Deep research
Summary
CagriSema combines cagrilintide and semaglutide in one weekly injection. See how it works, what Phase 3 trials found, and where FDA review stands today.
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 receptor, enhancing glucose-dependent insulin release, slowing gastric emptying, and reducing appetite. Cagrilintide mimics amylin, 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?
Safety note
Status: Investigational combination peptide, not yet approved (under FDA review as of 2026)
Category: In clinical trials · Primary body area: Digestive & weight
No. CagriSema is investigational. According to company disclosures, Novo Nordisk submitted it to the FDA in the fourth quarter of 2025 for weight management, and it is under review but not approved.
What does the research show?
Editor’s note
Evidence strength: Deep research (1 human · 0 animal/cell studies)
Two large, consistent Phase 3 trials show substantial weight loss versus placebo in both obesity and type 2 diabetes, though it is not FDA-approved, its obesity result came in below expectations, and it did not beat tirzepatide head-to-head.
Two large Phase 3 trials tested CagriSema against placebo, with these results according to PubMed.
| Trial | Population | Mean weight change with CagriSema | Mean weight change with placebo |
|---|---|---|---|
| REDEFINE 1 | Obesity or overweight without diabetes | About -20% over 68 weeks | About -3% |
| REDEFINE 2 | Obesity and type 2 diabetes | About -14%, with most participants reaching their blood-sugar target | About -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.
Sources: the REDEFINE 1 trial (Garvey et al., New England Journal of Medicine, 2025, DOI: 10.1056/NEJMoa2502081) and REDEFINE 2 (Davies et al., New England Journal of Medicine, 2025, DOI: 10.1056/NEJMoa2502082), 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.
Registered human trials
1 registered human trial on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
- [5]
- [6]
- [7]
- [8]
- [9]
- [10]
- [11]
- [12]
- [13]
- [14]
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