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This entry or formulation may be investigational and may not correspond to an FDA-approved product; safety and efficacy may not have been established. Kairo lists it for identification and record-keeping only.
Overview
Product & regulatory status
FDA identifies cagrilintide as an unapproved drug.
Amylin pathway
The development rationale is to reproduce and prolong amylin-related satiety signaling. [1]
What the evidence shows
Cagrilintide alone
A 26-week phase 2 study in adults without diabetes found greater weight reduction with cagrilintide than placebo. It included an active liraglutide comparison; results depend on the specific study arms. [1]
Combination research is separate
REDEFINE 1 tested cagrilintide with semaglutide over 68 weeks. The combination reduced weight more than placebo. That result should not be attributed entirely to cagrilintide alone. [2]
What remains unknown
Trials of CagriSema do not establish the safety of combining cagrilintide with retatrutide or other research mixtures.
Safety
Adverse effects
Gastrointestinal symptoms, including nausea, were prominent in the cagrilintide phase 2 study; tolerability is part of the treatment effect. [1]
Regulatory distinction
FDA states that cagrilintide is not a component of an approved drug; commercially offered preparations should not be equated with trial supply. [3]
Understanding product quality
Compounded drugs are not FDA-approved finished products. Poor preparation can cause contamination or incorrect strength. A catalog entry or a research paper is not a quality assessment of your product. [4]
When to seek urgent help
Severe allergic symptoms such as trouble breathing, throat or tongue swelling, or fainting need immediate help. Call 911 or your local emergency number. This is general emergency information, not a complete list of risks for this compound. [5]
A starting point for discussion
This is not a complete list of adverse effects or interactions. Your health history, other medicines, and the exact formulation matter. Missing safety data is not evidence of safety.
Common questions
Is CagriSema the same as cagrilintide?
No. CagriSema refers to cagrilintide combined with semaglutide, so its evidence applies to that combination.
Questions for your clinician
Does the evidence match my condition and this exact product? What risks or interactions matter for me? How would we assess whether it is helping?
Sources
- 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 trial2021 · Primary research · PubMed
- Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity2025 · Primary research · PubMed
- FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight LossFDA · Retatrutide and cagrilintide status
- Compounding and the FDA: Questions and AnswersFDA · product quality and regulation
- AnaphylaxisMedlinePlus · recognizing an emergency
Educational information, not a recommendation to use a compound. Kairo does not give dosing advice. Review decisions with a licensed healthcare professional.