PMID-38092790 – Mazdutide Phase 2 Obesity RCT
Ji L, Jiang H, An P, et al. A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Nat Commun. 2023;14(1):8289.
Quick Reference
| Property | Value |
|---|---|
| PMID | 38092790 |
| DOI | 10.1038/s41467-023-44067-4 |
| Year | 2023 |
| Journal | Nature Communications |
| Study Type | RCT (Phase 2, randomized, double-blind, placebo-controlled) |
| Evidence Level | II |
| Sample | n=240 Chinese adults with overweight or obesity |
| Peptide(s) Studied | Mazdutide |
Key Findings
- Mean percentage change from baseline to week 24 in body weight: -6.7% (3 mg), -10.4% (4.5 mg), -11.3% (6 mg) vs. +1.0% placebo (all p<0.001)
- Dose-response relationship clearly demonstrated across 3, 4.5, and 6 mg doses
- Significant waist circumference reduction across all dose groups
- Improvements in fasting glucose, insulin, and lipid parameters observed
- Most common adverse events were gastrointestinal (nausea, diarrhea, vomiting), mostly mild-to-moderate
Study Design
Randomized, double-blind, placebo-controlled Phase 2 trial at multiple sites in China. Adults aged 18-75 with BMI >=28 kg/m2 or >=24 kg/m2 with at least one weight-related comorbidity. Participants randomized to mazdutide 3 mg, 4.5 mg, 6 mg, or placebo, administered subcutaneously once weekly for 24 weeks with dose escalation. Primary endpoint: percent change in body weight from baseline to week 24.
Limitations
- 24-week treatment duration — longer-term efficacy and safety not established
- Chinese population only
- No active comparator (semaglutide or tirzepatide)
- Moderate sample size per dose group
Clinical Relevance
This pivotal Phase 2 trial demonstrated that mazdutide achieves clinically meaningful weight loss (up to 11.3% at 6 mg) at 24 weeks, comparable to semaglutide 2.4 mg at similar timepoints. The clear dose-response relationship and acceptable safety profile supported Phase 3 development. Published in Nature Communications, lending credibility to the dual agonist approach.
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#research #RCT #mazdutide #evidence-level-II #metabolic