Peptide · Fact sheet
Cagrilintide
Also known as AM833 · long-acting amylin analog
Cagrilintide is an investigational amylin analog—not an FDA-approved weight-loss medicine. Phase 3 trials report substantial average weight reduction alone and with semaglutide, while tolerability, long-term outcomes, and regulatory review remain separate questions.
What is Cagrilintide?
Cagrilintide is engineered to activate amylin receptors for longer than natural amylin.
It is being developed both as a single investigational drug and together with semaglutide under the name CagriSema; combination results cannot be attributed entirely to cagrilintide.
Benefits people look for
The amylin pathway offers a distinct satiety signal that can complement GLP-1 biology.
Large Phase 3 programs have moved the candidate well beyond early mechanism studies, but online access or combination claims are not evidence of approval.
What the evidence supports
- REDEFINE 1 reported meaningful average weight reduction with cagrilintide alone and a larger effect with the CagriSema combination.
- The combination also improved glycemic outcomes in a Phase 3 diabetes trial, but that does not isolate the contribution of each component.
All research areas
- Obesity and overweight
- Type 2 diabetes
- Blood pressure and cardiometabolic markers
- Combination treatment with semaglutide
- Chronic weight management
- Type 2 diabetes
- Fixed-combination metabolic treatment
Anecdotal reports & lived experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens.
No attributable personal reports are summarized here yet. The benefits above describe research interests; the side effects below come from the cited medical sources.
We do not fill this gap with unsourced testimonials or estimated success rates.
Side effects & risks
- Gastrointestinal adverse effects, including nausea and vomiting, were common in the development program.
- Combination tolerability and treatment discontinuation affect how trial efficacy translates into practice.
- Long-term and uncommon harms remain less characterized than for approved medicines.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research: how strong is it?
Moderate human evidenceLarge randomized Phase 3 studies show weight and glucose effects, including a cagrilintide-only group in REDEFINE 1. Regulatory review, long-term cardiovascular outcomes, and real-world safety are not yet established as they are for approved products.
Selected research to read
Phase 3 trial record covering cagrilintide, semaglutide, their combination, and placebo.
Large obesity trial reporting outcomes for the combination and individual components.
Controlled combination trial in adults with overweight or obesity and type 2 diabetes.
FDA approval & research status
Cagrilintide and CagriSema remain investigational in the United States. Completed and ongoing Phase 3 trials do not equal FDA approval.
No FDA-approved use is documented in the records summarized on this page.
Late-stage clinical development
Cagrilintide and CagriSema have Phase 3 records and reports, but no FDA-approved product. Combination evidence should not be treated as cagrilintide-only approval.
This summarizes the cited product or research record. Trial phases do not establish successful completion of earlier stages, and a stopped program is not ongoing development. Approval applies only to the labeled product, use and population.
What we still don’t know
- Whether FDA will approve cagrilintide alone, CagriSema, both, or neither
- Long-term cardiovascular and other clinical outcomes
- How much benefit and risk come from each component of CagriSema
- Durability after treatment ends
The takeaway
Cagrilintide has serious late-stage evidence and may become an important amylin medicine. Today it is still investigational, and CagriSema evidence should not be simplified into a cagrilintide-only promise.
Sources & further reading
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- 1clinical trialsClinicalTrials.gov: REDEFINE 1
Phase 3 trial record covering cagrilintide, semaglutide, their combination, and placebo.
- 2pubmedREDEFINE 1 randomized Phase 3 report
Large obesity trial reporting outcomes for the combination and individual components.
- 3pubmedREDEFINE 2 randomized Phase 3 report
Controlled combination trial in adults with overweight or obesity and type 2 diabetes.