Mechanism · Research Data · Side Effects · No Doses
Cagrilintide is a long-acting amylin analogue being studied for weight management. Phase 2 data support an effect as a standalone compound, while Phase 3 trials have tested it with semaglutide as CagriSema. The combination produced substantial average weight loss in trials, with gastrointestinal effects among the most common adverse events. Trial results do not make it an approved or suitable treatment for any individual.
| Evidence Type | Status |
|---|---|
| Human RCT | ✔ |
| Observational | ✗ |
| Animal Studies | ✔ |
| In Vitro | ✔ |
| Regulatory Approval | ✗ (not yet approved; under regulatory review as part of CagriSema as of the compound's most recent trial data) |
Phase II trials of cagrilintide as a standalone agent reported dose-dependent weight loss in people with obesity, with the highest arm studied in those trials (2.4 mg weekly) associated with meaningfully greater weight reduction than placebo over 26 weeks in published trial data.
The REDEFINE Phase 3 trial programme evaluated CagriSema in people with obesity and overweight, including participants with and without type 2 diabetes. Published REDEFINE 1 results (2024) reported average weight loss of approximately 20.4% over 68 weeks in participants without diabetes on CagriSema, compared with a smaller reduction on semaglutide alone and placebo, though the results in participants with type 2 diabetes (REDEFINE 2) showed a smaller magnitude of weight loss than had been anticipated, prompting continued research interest in optimising the combination and dosing strategy.
Trials assessing CagriSema in populations with type 2 diabetes have reported reductions in HbA1c alongside weight loss, consistent with the complementary glucagon-suppressing and satiety-enhancing mechanisms of amylin and GLP-1 receptor pathways studied together.
| Study / Model | Reported Effect |
|---|---|
| Phase Ib/II Monotherapy Trial (Lau DCW et al., Lancet 2021) | Reported dose-dependent weight loss with cagrilintide monotherapy versus placebo over 26 weeks, with favourable tolerability at studied doses. |
| REDEFINE 1 Phase 3 (2024, NEJM/company disclosure) | CagriSema reported approximately 20.4% mean weight loss at 68 weeks in adults with obesity/overweight without diabetes, versus semaglutide alone and placebo comparator arms. |
| REDEFINE 2 Phase 3 (2024, type 2 diabetes population) | Reported weight loss and HbA1c reduction in participants with type 2 diabetes, though weight-loss magnitude was reported as below internal expectations, prompting continued analysis. |
| Preclinical Rodent Amylin Receptor Studies | Confirmed amylin/calcitonin receptor agonism and reduced food intake in rodent obesity models, supporting the translational rationale for human trials. |
This site does not publish doses, durations or frequencies for any compound. Published research protocols for this compound vary considerably between studies in design, intensity and duration. Those details are not something to copy from a fitness website — anyone researching this compound should read the primary literature directly and talk to a doctor who knows their bloods.
Reported safety profile across REDEFINE trials was broadly consistent with the known tolerability profile of GLP-1 and amylin receptor agonists as a drug class; no unexpected safety signals specific to cagrilintide were highlighted in published Phase 3 data as of the most recent trial readouts.
Research base note: Cagrilintide has a well-documented Phase 2 and Phase 3 clinical trial record, primarily as part of the CagriSema combination, published in high-impact peer-reviewed journals and company disclosures. As of the most recent published data, cagrilintide/CagriSema had not yet completed full regulatory approval; readers should check current regulatory status independently before treating any approval-related claim as final.
What is Cagrilintide and is it the same as Ozempic or Wegovy?
No. Cagrilintide is a long-acting amylin analogue, a different hormone pathway to semaglutide, the GLP-1 in Ozempic and Wegovy. Amylin receptor activation contributes to satiety and slowed gastric emptying through a mechanism separate from, but complementary to, GLP-1 signalling.
What is CagriSema?
CagriSema is the fixed-dose combination of cagrilintide with semaglutide, studied in the Phase 3 REDEFINE trial programme on the rationale that amylin and GLP-1 pathways act on complementary appetite circuits. Published REDEFINE 1 data reported around 20.4% average weight loss at 68 weeks in participants without diabetes.
Is Cagrilintide approved for use in Ireland?
Not as of the most recent published trial data. Cagrilintide and CagriSema were still under regulatory review at the time of this compound's most recent trial disclosures, and readers should check current EMA and HPRA status independently rather than treat approval as final.
What side effects were reported in the Cagrilintide and CagriSema trials?
Gastrointestinal effects, including nausea, vomiting, diarrhoea and constipation, were the most commonly reported, consistent with other amylin- and GLP-1-pathway agents. Published Phase 3 data did not highlight any safety signal specific to cagrilintide beyond the known tolerability profile of this drug class.
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