Cagrilintide

What it is

Cagrilintide is a long-acting amylin analog — a modified version of amylin, a hormone co-secreted with insulin that promotes satiety, slows gastric emptying, and suppresses glucagon. It acts at amylin and calcitonin receptors, a distinct mechanism from the GLP-1 receptor agonists it is often grouped with. Its structure gives it a roughly week-long half-life that supports once-weekly subcutaneous injection. It is investigational and not approved on its own.

What it’s approved or studied for

Cagrilintide has no approved indication. It is being developed by Novo Nordisk for weight management, studied both as a standalone injection and, more prominently, in a fixed combination with semaglutide marketed in trials as CagriSema. The rationale is that pairing an amylin analog with a GLP-1 receptor agonist engages two complementary appetite pathways.

What human evidence exists

The evidence has advanced from early-phase to phase 3. A phase 2 dose-finding trial (Lancet 2021) established a dose-dependent weight-loss effect for cagrilintide alone, with the top dose outperforming liraglutide 3.0 mg. A phase 1b trial (Enebo et al., Lancet 2021) supported combined dosing with semaglutide. The pivotal REDEFINE phase 3 program then tested CagriSema: REDEFINE 1 (NEJM 2025) reported 22.7% mean weight loss at 68 weeks, with a cagrilintide-alone arm at 11.8%, and REDEFINE 2 extended testing to type 2 diabetes. Standalone weight-loss evidence is therefore Grade B (Supported); glycemic evidence remains Grade C (Preliminary).

The major unknowns

Cagrilintide is not approved, so long-term safety and durability are unestablished. Most of the strongest data describe the combination with semaglutide rather than the drug alone, and it can be hard to separate cagrilintide’s independent contribution from semaglutide’s. No dedicated cardiovascular outcomes trial has reported, post-cessation weight regain has not been well characterized, and — as with the whole weight-loss class — a meaningful fraction of weight lost is lean tissue.

Most important safety considerations

Gastrointestinal effects (nausea, vomiting, diarrhea, constipation) dominate the side-effect profile and are dose-related, alongside injection-site reactions. Because it is investigational, no formal contraindication list has been established through regulatory review, and it should be regarded as available only within clinical trials. This page is a research summary, not medical advice — any decision about an investigational agent belongs with a clinician.