What Is Cagrilintide Used For? Approved Uses and Current Regulatory Status

The short answer

Cagrilintide is an investigational medicine in clinical trials. Across the published sources summarised on this page, it was described as an agent in clinical development rather than as a marketed product carrying United States prescribing information. That means there is no approved label indication to quote, no product name and revision year to name, and no approved use to list. What does exist is a body of trial literature describing what researchers studied and what they reported.

Because of that status, the honest answer to the question "what is cagrilintide used for" is a regulatory one: at the time of the cited literature, cagrilintide had an investigational status, and the settings in which it has been studied are research settings, not approved uses. Anything described below is trial evidence, not an indication.

Readers looking for a broader overview of the molecule can see the cagrilintide learn hub.

What cagrilintide is, in pharmacological terms

Cagrilintide was developed as a long acting analogue of amylin, the pancreatic hormone co-secreted with insulin. A medicinal chemistry paper described the design work that produced a long acting amylin analogue suitable for once weekly administration (PMID 34288673). A review of amylin biology set out why amylin receptor agonism attracted interest as an approach to body weight regulation, describing effects on satiety signalling and food intake in the preclinical and early clinical record (PMID 34929674). A later cardiology review summarised cagrilintide specifically as a long acting amylin analogue under investigation for obesity (PMID 36883831).

Amylin receptor agonism is an active research area beyond this one molecule. A 2025 paper describing eloralintide reported the discovery and early clinical proof of concept work for another amylin receptor agonist being studied in obesity (PMID 41109426). That context matters only because it shows the class, not because it changes cagrilintide's status.

What a label indication is, and why this page has none to list

An approved indication is a sentence in a regulatory label stating the population and condition for which a product has been authorised, tied to a named product and a prescribing information revision date. Approval follows review of pivotal trial data by an agency such as the US Food and Drug Administration.

For cagrilintide, the cited sources describe pipeline and trial stages rather than an authorised label. A 2025 review of the phase 2 and phase 3 obesity pipeline placed amylin analogues including cagrilintide among agents under active investigation (PMID 40022548). A 2025 clinical review of weight management treatment similarly discussed combination amylin and incretin approaches within a development context (PMID 40865172). Neither source documented an approved cagrilintide label with an indication.

The trials behind the development programme

Phase 1b: concomitant administration with semaglutide

A randomised, controlled phase 1b trial examined the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of cagrilintide given with semaglutide 2.4 mg for weight management (PMID 33894838). The study was an early phase investigation of whether the two agents could be administered together, and researchers reported on tolerability and exposure rather than on long term outcomes (PMID 33894838).

Phase 2: once weekly dose finding

A multicentre, randomised, double blind, placebo controlled and active controlled phase 2 dose finding trial evaluated once weekly cagrilintide at doses of 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg and 4.5 mg over 26 weeks in people with overweight and obesity, with liraglutide 3.0 mg as the active comparator (PMID 34798060). Researchers reported greater mean reductions in body weight with cagrilintide than with placebo across the dose range studied in that trial (PMID 34798060). Dose levels are described here only to characterise the trial design; they are not directions for any individual.

Phase 3: coadministration in adults with overweight or obesity

A 2025 New England Journal of Medicine report described a trial of coadministered cagrilintide and semaglutide in adults with overweight or obesity, in which researchers reported greater mean body weight reduction with the combination than with the comparator groups (PMID 40544433).

Phase 3: adults with overweight or obesity and type 2 diabetes

A companion 2025 report described cagrilintide-semaglutide in adults who had both overweight or obesity and type 2 diabetes, with the study reporting body weight and glycaemic outcomes in that population (PMID 40544432). Both of these reports describe trial populations that were enrolled and monitored under study protocols.

Pooled analysis of the earlier evidence

A 2024 systematic review and meta analysis pooled trials of cagrilintide alone and in combination with semaglutide as anti obesity medications and reported on efficacy and safety across the included studies (PMID 39676787). Pooled analyses of this kind summarise what the component trials reported; they do not establish regulatory approval.

Regulatory history of the indications

There is no approved indication history to recount for cagrilintide in the sources cited here. The sequence documented in the published literature is a development sequence: design and characterisation of a long acting amylin analogue (PMID 34288673), early phase combination work with semaglutide 2.4 mg (PMID 33894838), a 26 week phase 2 dose finding trial (PMID 34798060), and phase 3 reports in adults with overweight or obesity and in adults with type 2 diabetes (PMID 40544433, PMID 40544432).

Reviews published in 2025 positioned cagrilintide within the obesity pharmacotherapy pipeline rather than within the set of marketed products (PMID 40022548, PMID 40865172). Approval status can change, and the authoritative source for whether any product has been authorised, and for the exact wording of any indication, is the current prescribing information published by the manufacturer and the relevant regulator.

A note on unapproved sources

Material sold online as cagrilintide, and compounded preparations, fall outside the authorised supply chain and outside the regulatory status described above. They are not approved uses and are not covered by any label. This page does not describe them as uses.

Adverse Events: What Studies Report

Safety and tolerability were reported alongside efficacy in the development programme. The phase 1b trial was designed specifically to assess safety, tolerability, pharmacokinetics and pharmacodynamics of cagrilintide given with semaglutide 2.4 mg, and researchers reported tolerability findings from that design (PMID 33894838). The phase 2 dose finding trial reported that gastrointestinal events were the most frequently reported adverse events across the cagrilintide dose groups studied over 26 weeks (PMID 34798060).

The 2024 systematic review and meta analysis of cagrilintide alone and with semaglutide evaluated safety outcomes alongside efficacy across the pooled trials (PMID 39676787). The 2025 phase 3 reports in adults with overweight or obesity and in adults with type 2 diabetes each reported adverse event profiles for the combination regimens studied (PMID 40544433, PMID 40544432). Interpretation of these findings for any individual is a clinical matter.

Where the wider class discussion sits

A 2026 review examined outcomes beyond body weight across obesity medications, describing multisystem effects reported in the literature for this therapeutic area (PMID 42208956). A 2021 review of amylin as a future obesity treatment set out the earlier rationale for targeting amylin receptors (PMID 34929674). These broader discussions describe a research field, and they do not assign approved uses to any individual investigational agent.

Questions that belong with a prescribing clinician

Whether any medicine, approved or investigational, is appropriate for a particular person depends on diagnosis, medical history, concurrent medicines and monitoring. Those judgements sit with a licensed prescribing clinician who can review an individual record. Questions about eligibility for a clinical trial are also clinical questions and are handled by trial investigators and treating clinicians.

This page is for educational purposes only and is not medical advice; consult a licensed physician about any medical question, including any question about investigational medicines or participation in research.

References

• Development of Cagrilintide, a Long-Acting Amylin Analogue (Journal of Medicinal Chemistry, 2021)
• Amylin as a Future Obesity Treatment (Journal of Obesity & Metabolic Syndrome, 2021)
• Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial (Lancet, 2021)
• Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial (Lancet, 2021)
• Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity (Cardiology in Review, 2024)
• Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (Cagrisema) as Anti-Obesity Medications: A Systematic Review and Meta-Analysis (Indian Journal of Endocrinology and Metabolism, 2024)
• Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (New England Journal of Medicine, 2025)
• Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (New England Journal of Medicine, 2025)
• The promise of glucagon-like peptide 1 receptor agonists (GLP-1RA) for the treatment of obesity: a look at phase 2 and 3 pipelines (Expert Opinion on Investigational Drugs, 2025)
• Weight management treatment in obesity (Medicina Clinica, 2025)
• Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept (Molecular Metabolism, 2025)
• Beyond weight loss: multisystem benefits of obesity medications (Lancet Diabetes & Endocrinology, 2026)