Retatrutide trial overview
Retatrutide: an overview of phase 2 trial NCT04881760 — 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, placebo-controlled phase 2 trial. Six retatrutide groups, each assigned by the investigators to a different target, plus placebo. The assignments are in the linked protocol and paper and are not reproduced here.
Population
338 adults with BMI 30 or higher, or 27 to under 30 with at least one weight-related condition; randomised 2:1:1:1:1:2:2.
Duration
48 weeks of treatment (primary endpoint at week 24), then a 4-week safety follow-up
Reported results
Mean weight change at 48 weeks ranged from −8.7% in the lowest-target group to −24.2% in the highest-target group, vs −2.1% with placebo. Gastrointestinal events were the most common adverse events.
Limitations
One phase 2 trial in adults with obesity or overweight, 48 weeks of treatment. It was not designed to establish long-term safety or clinical outcomes, and its results are not an approval and do not establish safety or effectiveness for anyone outside the trial.
Regulatory context
Investigational. The FDA has not approved retatrutide, and no approval elsewhere is listed in this site's sources, so there is no label, no approved amount and no missed-dose rule here.
Sources
Educational use only, never medical advice. No doses.