CagrilintideWeight Loss / GLP-1
Amylin analog studied for appetite and weight.
- Status
- Research / not approved
- Developer
- Novo Nordisk (AM833 / NN9838)
- Receptors / target
- Long-acting amylin analog; agonist at amylin receptors (AMY1-3) and the calcitonin receptor; reduces appetite and food intake and slows gastric emptying
- FDA-approved?
- NO
- Prescription available?
- NO
- Studied for
- obesityweight losstype 2 diabetesappetite / satiety
Overview
Cagrilintide (AM833) is an investigational long-acting amylin analog developed by Novo Nordisk for chronic weight management, given once weekly by subcutaneous injection. It is studied both on its own and, more prominently, co-formulated with the GLP-1 analog semaglutide as the combination "CagriSema." It is not approved by the FDA for any use and remains investigational; it is sold here for research purposes only, not as a prescription medicine.
Mechanism
Amylin is a hormone co-secreted with insulin from pancreatic beta cells that signals satiety, slows gastric emptying and blunts post-meal glucagon. Cagrilintide is a modified, acylated amylin analog engineered for a long half-life, acting as an agonist at amylin and calcitonin receptors in appetite-regulating brain regions. By reducing appetite and food intake it drives weight loss, and its mechanism is complementary to (rather than overlapping with) GLP-1 receptor agonism — the rationale for the CagriSema combination.
Clinical evidence
In a phase 2 dose-finding trial in obesity, cagrilintide alone produced dose-dependent weight loss versus placebo (Lau et al., Lancet 2021). Much of the most striking efficacy data, however, comes from the combination: phase 1b (Enebo et al., 2021) and a phase 2 type-2-diabetes trial (Frías et al., Lancet 2023) showed CagriSema improved weight and glycaemic control more than either agent alone, and the phase 3 REDEFINE 1 trial (Garvey et al., NEJM 2025) confirmed large weight reductions for the combination over 68 weeks. Readers should note the distinction: most headline weight-loss figures reflect cagrilintide combined with semaglutide, not cagrilintide as a standalone agent.
Safety profile
Across trials, cagrilintide (alone and with semaglutide) has been generally well tolerated, but the most common adverse events are gastrointestinal — nausea, vomiting and dyspepsia — and are dose-related. Because the compound is still investigational, there are no long-term human safety data and no approved indication. Research use only; nothing here is therapeutic or dosing guidance.
- Weeks 1–4
Early dose titration; nausea/GI effects most common. Investigational amylin analog — not approved.
- Weeks 8–20
Progressive appetite reduction and weight loss in the phase 2 trials, most studied combined with semaglutide as CagriSema.
- ~Week 68
Phase 3 REDEFINE 1 endpoint for the CagriSema combination; standalone cagrilintide time-course is less defined.
Reported in published literature and user reports. Not a complete list, and not medical advice.
- Nausea and vomiting
- Decreased appetite
- Injection-site reactions
- Constipation
If severe or unexpected symptoms occur, contact a qualified medical professional. PEPTIDES·INDEX does not provide medical advice.
- No established human contraindications exist because cagrilintide is investigational; formal labeled contraindications have not been defined.
- Pregnancy and breastfeeding — no human safety data; weight-loss agents are generally avoided in pregnancy.
- Known hypersensitivity to cagrilintide or excipients; long-term human safety is uncharacterized.
- Other appetite/glycemic agents (e.g. GLP-1 analogs such as semaglutide)Studied in deliberate combination (CagriSema); additive gastrointestinal and appetite effects observed, but a formal interaction profile is not established (research use only).
Compare
- vs Semaglutide
GLP-1 partner drug in the CagriSema combination
FAQ
Is cagrilintide FDA-approved?
No. It is an investigational long-acting amylin analog from Novo Nordisk, studied alone and in the CagriSema combination. It is not approved for any use and is sold here research-use-only.
What is CagriSema?
CagriSema is the investigational co-formulation of cagrilintide with the GLP-1 analog semaglutide. Many of the headline weight-loss figures, including the phase 3 REDEFINE 1 results, reflect the combination rather than cagrilintide used on its own.
How is its mechanism different from GLP-1 drugs?
Cagrilintide is an amylin/calcitonin receptor agonist that reduces appetite and slows gastric emptying through a pathway complementary to GLP-1 receptor agonism — which is the rationale for combining it with semaglutide.
How was cagrilintide dosed in trials?
By once-weekly subcutaneous injection, titrated over several weeks (the phase 2 work studied doses up to 2.4 mg). Its long half-life of roughly 6-8 days supports weekly dosing. These are investigational trial regimens, not approved or recommended doses.
What were the main side effects?
Gastrointestinal effects were most common and dose-related — nausea, vomiting and dyspepsia, along with decreased appetite and constipation. The compound was generally well tolerated in trials, but as an investigational agent it has no long-term human safety data.
Does cagrilintide work on its own, or only with semaglutide?
Both have been studied. A phase 2 dose-finding trial showed cagrilintide alone produced dose-dependent weight loss versus placebo, but the largest efficacy figures come from the CagriSema combination. Readers should note which results refer to the standalone agent versus the combination.
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Starting references for the library summary. These are not dosing instructions or medical advice.
For research-use educational context only. Not medical advice and not a recommendation to use any compound. Consult a qualified healthcare professional before any health decision.