Cagrilintide

What it is

Cagrilintide is an investigational long-acting amylin analog — a peptide modeled on the natural hormone amylin and engineered to last long enough for once-weekly dosing. It is being studied for weight management, including in combination with semaglutide (an investigational combination referred to as CagriSema). It is not approved by the FDA for any use.¹

How it works

Amylin is a hormone co-secreted with insulin from the pancreas after meals. It promotes a sense of fullness, slows stomach emptying and helps regulate post-meal glucose. Cagrilintide mimics amylin’s satiety signaling in a long-acting form, with the goal of reducing appetite and food intake.^1,2 Because amylin and GLP-1 act through different pathways, combining cagrilintide with a GLP-1 drug is being studied as a way to achieve additive effects.

What the evidence shows

Animal studies

Preclinical work on amylin signaling established it as a satiety pathway and supported the design of long-acting amylin analogs for weight management, motivating human trials.²

Human studies

Early human trials of cagrilintide — alone and combined with semaglutide — have reported meaningful weight reductions over the study periods.³ These results are encouraging but remain preliminary, pending larger and longer pivotal trials and a regulatory decision. Until those complete, conclusions about durable benefit and safety are provisional.

Dosages reported in the literature

Informational only. Cagrilintide is an investigational drug. The figures below describe doses used in studies; they are not a recommendation or a prescription. This compound is not approved and should only be received within a regulated clinical trial.

Because cagrilintide is investigational, no dose here should be read as established as safe or effective for general use.

Safety & side effects

In trials, the most commonly reported side effects have been gastrointestinal — nausea and related symptoms — consistent with appetite-acting agents, often dose-related and tending to ease over time.³ Because there are no long-term, real-world safety data yet, the full risk profile is genuinely unknown.

A practical concern in the unregulated market is product quality. “Research” cagrilintide sold outside of clinical trials does not carry the quality, purity or dose assurances of an approved medicine.

Legal & regulatory status

Cagrilintide is not approved by the FDA for any use. It is investigational and being evaluated in clinical trials, including the CagriSema combination. Rules differ by country and change over time.¹

References

1. Kruse T, Hansen JL, Dahl K, Schaffer L, et al. Development of Cagrilintide, a Long-Acting Amylin Analogue. Journal of Medicinal Chemistry. 2021;64(15):11183-11194. doi:10.1021/acs.jmedchem.1c00565 [PMID 34288673, doi:10.1021/acs.jmedchem.1c00565]
2. Lutz TA. Pancreatic amylin as a centrally acting satiating hormone. Current Drug Targets. 2005;6(2):181-189. doi:10.2174/1389450053174596 [PMID 15777188, doi:10.2174/1389450053174596]
3. Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietilainen KH, Rubino D, Batterham RL. 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;398(10317):2160-2172. doi:10.1016/S0140-6736(21)01751-7. [Companion CagriSema combination trial: Frias JP, et al. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a phase 2 trial. Lancet. 2023;402(10403):720-730. doi:10.1016/S0140-6736(23)01163-7] [PMID 34798060, PMID 37364590, doi:10.1016/S0140-6736(21)01751-7, doi:10.1016/S0140-6736(23)01163-7]