FDA (US): Not approved; application submitted in December 2025 for weight management, decision expected in the fourth quarter of 2026.
EMA (EU): Not approved.
Dose
There is no established dose in humans. In the phase 3 trials (REDEFINE), cagrilintide 2.4 mg + semaglutide 2.4 mg subcutaneously once a week was used, with a 16-week escalation (NEJM 2025).
Safety
Digestive effects very frequent (79.6% vs 39.9% with placebo in REDEFINE 1): nausea, vomiting, diarrhea, and constipation, mainly during escalation. Use only in clinical trials or research, under medical supervision; buying it is not recommended.
Differences between women and men
In a post hoc analysis of REDEFINE 1 presented at a conference (1,902 women), weight loss at 68 weeks was 26.7% in premenopausal, 24.8% in perimenopausal, and 23.1% in postmenopausal women (vs ~2% with placebo); differences between stages were not statistically analyzed.
Effect by goal · level of evidence
Weight loss in obesity without diabetes
improvesHighRCT (AA)in people
−20.4% weight
REDEFINE 1 trial (3,417 adults, 68 weeks): the combination reduced weight by 20.4% vs 3.0% with placebo, and outperformed semaglutide alone (about 5.5 points more) and cagrilintide alone (about 8.9 points more).
Semaglutide activates the GLP-1 receptor (satiety, lower glucose, slower gastric emptying) and cagrilintide mimics amylin, which provides satiety through a different brain pathway. Together they reduce appetite more than either one alone.
What the evidence says
In people
Weight loss in obesity without diabetes. REDEFINE 1 trial (3,417 adults, 68 weeks): the combination reduced weight by 20.4% vs 3.0% with placebo, and outperformed semaglutide alone (about 5.5 points more) and cagrilintide alone (about 8.9 points more). PubMed 40544433