Cagrilintide trial overview
Cagrilintide: an overview of phase 2 trial NCT03856047 — population, study design, reported results and limitations, with the primary citations. Investigational; no dose amounts, cadence or escalation steps are reproduced.
Study design
Randomised, double-blind phase 2 dose-finding trial with five cagrilintide groups, each assigned a different target, plus placebo and an open-label liraglutide comparator group. The assignments are in the linked paper and registry record and are not reproduced here.
Population
706 adults without diabetes with BMI 30 or higher, or 27 or higher with hypertension or dyslipidaemia, at 57 sites in 10 countries.
Duration
26 weeks of treatment, then 6 weeks of follow-up without treatment
Reported results
Mean weight change at week 26 (trial product estimand) ranged from −6.0% to −10.8% across the cagrilintide groups, vs −3.0% with placebo. Gastrointestinal events affected 41–63% of participants in the cagrilintide groups vs 32% on placebo, mainly nausea.
Limitations
One 26-week phase 2 trial in adults without diabetes. The headline figures use the trial product estimand, which estimates the effect if participants stayed on treatment, and the study was too short to assess long-term safety or outcomes.
Regulatory context
Investigational. No approved labeling exists.
Sources
Educational use only, never medical advice. No doses.