Cagrilintide (and CagriSema)

Summary

Cagrilintide is an investigational (still in trials) once weekly amylin analog, a lab-made version of a pancreas hormone that reduces appetite through a different pathway from GLP-1 drugs, and it is being developed mainly as CagriSema, a fixed combination with semaglutide 2.4 mg. Alone it produced 10.8% weight loss at 4.5 mg over 26 weeks in a phase 2 trial of 706 people, and CagriSema produced 20.4% weight loss at 68 weeks in adults without diabetes (REDEFINE 1, 3,417 people) and 13.7% in adults with type 2 diabetes (REDEFINE 2, 1,206 people). As of September 2026 neither form is FDA approved, neither can lawfully be compounded (custom-made by a pharmacy), and cagrilintide is prohibited in sport under WADA section S0, the anti-doping ban on unapproved substances.

What is Cagrilintide?

Cagrilintide is an investigational long acting amylin analog (acylated, once weekly), developed alone and in fixed combination with semaglutide 2.4 mg. It is also known as AM833, NN9838, CagriSema (with semaglutide), long acting amylin analog, cagrilintide semaglutide, Cagri-Sema.

How does it work?

Cagrilintide is an analog of amylin, a hormone co-secreted with insulin by pancreatic beta cells. It activates amylin receptors and calcitonin receptors in the area postrema and hypothalamus, slowing gastric emptying, suppressing glucagon, and increasing satiety. Because this pathway is separate from GLP-1 signaling, combining it with semaglutide produces additive weight loss. A fatty acid side chain binds albumin for once weekly dosing.

What does the evidence say about Cagrilintide?

One phase 2 monotherapy trial (n = 706, 26 weeks) and a phase 3 program for the semaglutide combination. Alone, cagrilintide 0.3 to 4.5 mg produced 6.0% to 10.8% weight loss versus 3.0% on placebo. In REDEFINE 1 (n = 3,417, 68 weeks) the combination produced 20.4% weight loss versus 3.0% on placebo; in REDEFINE 2 (n = 1,206, 68 weeks, type 2 diabetes) 13.7% versus 3.4%; and in REDEFINE 5 (n = 331, East Asia) it beat semaglutide alone by 6.5 percentage points. In the open label REDEFINE 4 trial (n = 809, 84 weeks) the combination produced 23.0% weight loss versus 25.5% with tirzepatide 15 mg and missed non-inferiority (manufacturer topline, not peer reviewed). In type 2 diabetes, three published phase 3 trials support the combination: REIMAGINE 2 (n = 2,713, 68 weeks, on metformin with or without an SGLT2 inhibitor) found it superior to semaglutide 2.4 mg alone on HbA1c (minus 1.91 versus minus 1.75 points); REIMAGINE 1 (n = 189, 40 weeks, not controlled by diet and exercise alone) showed HbA1c minus 1.8 versus minus 0.1 points and weight minus 13.8% versus minus 1.4% on placebo; and REIMAGINE 3 (n = 274, 40 weeks, added to basal insulin) showed HbA1c minus 2.33 versus minus 0.66 points with 10% to 12% weight loss. An earlier phase 2 trial (n = 92, 32 weeks) showed similar direction of effect.

Human evidence

Phase 2 monotherapy (Lau 2021): 706 adults without diabetes with BMI 30 or higher (or 27 with a comorbidity), 26 weeks; weight loss 6.0% to 10.8% across 0.3 to 4.5 mg versus 3.0% on placebo, and 10.8% with 4.5 mg versus 9.0% with liraglutide 3.0 mg. REDEFINE 1 (Garvey 2025): 3,417 adults without diabetes, 68 weeks; estimated mean weight change minus 20.4% with cagrilintide 2.4 mg plus semaglutide 2.4 mg versus minus 3.0% with placebo (difference 17.3 percentage points). REDEFINE 5 (2026): 331 adults in Japan and Taiwan, 68 weeks; minus 18.4% with the combination versus minus 11.9% with semaglutide alone. Phase 2 type 2 diabetes (Frias 2023): 92 adults, 32 weeks, clinically relevant HbA1c improvement with the combination.

Animal evidence

Rodent pharmacology established amylin receptor mediated reductions in food intake and body weight and the additive effect with GLP-1 receptor agonists. No labeling exists because the drug is not approved.

Key studies

Conditions studied

Is Cagrilintide legal in the United States?

FDA and compounding status

Not FDA approved as of the last verification date, either alone or in the fixed combination with semaglutide. Because cagrilintide is not a component of an approved drug, has no USP monograph, and is not on the 503A bulks list, it cannot lawfully be compounded. Any product sold as cagrilintide or CagriSema outside a clinical trial is an unapproved drug. Check FDA for the status of any marketing application before relying on this record.

WADA status

WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.

Regulatory timeline

No regulatory events recorded.

Full tracker for Cagrilintide or the category-wide tracker.

What published studies of Cagrilintide used

Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.

Monotherapy phase 2: once weekly subcutaneous cagrilintide escalated to maintenance doses of 0.3, 0.6, 1.2, 2.4, or 4.5 mg. Phase 3 combination: cagrilintide 2.4 mg plus semaglutide 2.4 mg once weekly after a 16 week escalation. No approved label exists; these are trial regimens only.

Routes reported

What are the side effects and interactions of Cagrilintide?

Side effects

Interactions

Contraindications

How do people access Cagrilintide legally?

Typical cost: Not available through licensed channels. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity.

• Rules by state
• Verified provider directory

Compare Cagrilintide

• Cagrilintide vs pramlintide
• Liraglutide vs cagrilintide
• Semaglutide vs cagrilintide
• Tirzepatide vs cagrilintide

What's actually offered, and what that means for you

Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make cagrilintide lawful. Cagrilintide is not FDA approved and not on the 503A bulks list, so a pharmacy has no lawful basis to compound it. [6]

Enforcement is uneven. FDA mostly acts through warning letters to online sellers and import alerts that let it detain shipments, rather than stopping every seller. State pharmacy boards oversee pharmacies day to day, and their rules differ. [14] [15] [16]

What changes for you

• No FDA review of the product: a product sold outside a trial is an unapproved drug, and FDA has not checked its safety, effectiveness, or quality. [14]
• Identity, purity, sterility, and dose accuracy can vary from batch to batch. [14]
• Insurance rarely covers it, so you usually pay cash.
• For tested athletes, cagrilintide is prohibited at all times on the WADA list, whatever the source. [7]

What to check

Cagrilintide is not approved in the US, and no check makes a product sold outside a clinical trial lawful. Check for:

• Enrollment in a registered clinical trial (ClinicalTrials.gov lists them). Outside a trial, any product sold as cagrilintide is an unapproved drug.
• Labels such as "research use only" or "not for human consumption", which FDA does not accept for products sold for people. [14]
• A licensed prescriber's view on whether an approved drug fits your goal.

For weight management, approved GLP-1 drugs such as tirzepatide and semaglutide are available by prescription. See Tirzepatide, Semaglutide, GLP-1 hub.

Frequently asked questions

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

From the blog

• Peptides for weight loss, ranked by human evidence

  Tirzepatide, semaglutide, and liraglutide lead on human trials. Retatrutide is trial-only, and AOD-9604 and 5-amino-1MQ are animal-only. Ranking, legal status, and dated prices.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.