Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial.
Stanley H Hsia, Harold E Bays, Liana K Billings et al.
✦ AI-curated · Sources linked
In 30 seconds
This 48-week, US-based, multicentre, randomised, double-blind, placebo-controlled phase 2 trial evaluated once-weekly mazdutide in adults with obesity or overweight and without type 2 diabetes. Among 179 participants, mean bodyweight change at 32 weeks was -7·3% with 3–6 mg, -15·6% with 10 mg, and -18·1% with 16 mg, compared with -0·9% with placebo; all comparisons with placebo were significant (p<0·0001). Higher doses produced greater weight reduction, while gastrointestinal adverse events were common and treatment discontinuation due to adverse events was most frequent with 16 mg.
Key findings
- At 32 weeks, bodyweight changed by -7·3%, -15·6%, and -18·1% with mazdutide 3–6 mg, 10 mg, and 16 mg, respectively, versus -0·9% with placebo.
- Estimated treatment differences versus placebo ranged from -6·5% to -17·2% (p<0·0001, all comparisons).
- Gastrointestinal events were the most common adverse events and were mostly mild to moderate; adverse-event discontinuation occurred most often with 16 mg (20%).
- Additional bodyweight reductions were observed at 48 weeks.
Why it matters
The trial provides randomised evidence that mazdutide can reduce bodyweight in adults with obesity or overweight without type 2 diabetes, with greater reductions at the higher studied doses. The dose-related efficacy signal is relevant to ongoing evaluation of this dual glucagon and GLP-1 receptor agonist, while gastrointestinal tolerability and discontinuation at 16 mg are important considerations in assessing its benefit–risk profile.
What to keep in mind
This was a phase 2 trial with 179 participants and 48 weeks of follow-up; the abstract does not establish longer-term outcomes or effects in people with type 2 diabetes.