Plain-English fact sheet
Cagrilintide
Also known as AM833, long-acting amylin analog
Cagrilintide is a next-generation amylin analog with Phase 3 human evidence, especially in the CagriSema combination, but no FDA-approved product or use.
Quick answer
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.
By the PeptideFactSheets Editorial Team. Claims are source-checked under our editorial policy; clinician review is identified only when a named reviewer is shown.
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.
Why are people interested in it?
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.
Current regulatory status
Cagrilintide and CagriSema remain investigational in the United States. Completed and ongoing Phase 3 trials do not equal FDA approval.
What is it approved for?
No FDA-approved use. This matters because clinical-trial participation and products marketed online are not the same as an approved medicine.
What is it being studied for?
Investigational areas
- Chronic weight management
- Type 2 diabetes
- Fixed-combination metabolic treatment
Evidence snapshot
Large 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.
Potential benefits being researched
- 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.
Potential does not mean proven. Study design, population, endpoint, and regulatory review matter.
Known or possible 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.
What we still do not 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
Plain-English 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.
Research and reference links
Use these primary and reputable sources to verify status and read beyond this summary. Trial registries may list studies without proving a benefit.
- 1ClinicalTrials.gov: REDEFINE 1
Phase 3 trial record covering cagrilintide, semaglutide, their combination, and placebo.
- 2REDEFINE 1 randomized Phase 3 report
Large obesity trial reporting outcomes for the combination and individual components.
- 3REDEFINE 2 randomized Phase 3 report
Controlled combination trial in adults with overweight or obesity and type 2 diabetes.