Mazdutide trial overview

Mazdutide: an overview of phase 2 trial NCT04904913 — 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 with three mazdutide groups, each with its own matching placebo group. The assignments are in the linked paper and are not reproduced here.

Population

248 Chinese adults at 20 hospitals in China: BMI 24 or higher with hyperphagia and/or an obesity-related condition, or BMI 28 or higher. Mean age 35.5, mean BMI 31.8. Randomised 3:1:3:1:3:1 against matching placebo.

Duration

24 weeks of treatment (primary endpoint: % weight change at week 24)

Reported results

Mean weight change at week 24 ranged from −6.7% in the lowest-target group to −11.3% in the highest-target group, vs +1.0% with placebo. Diarrhoea, nausea and vomiting were among the most common adverse events. Mean heart rate rose 5.4–8.8 beats per minute on mazdutide vs 4.8 on placebo.

Limitations

One 24-week phase 2 trial in Chinese adults at 20 hospitals in China. Results may not apply to other populations, and the study was too short to assess long-term safety or outcomes.

Regulatory context

Education only. A summary of one trial in one population, not a prescribing schedule and not instructions for any product.

Sources

Educational use only, never medical advice. No doses.