Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial
Primary result · Least-squares mean percentage change from baseline in bodyweightResult — go to the resultEstimated treatment difference −6.5% to −17.2%Authors' conclusion
Once-weekly, subcutaneous mazdutide showed clinically meaningful bodyweight reduction in adults with obesity or overweight across all studied doses, with higher doses (10 mg and 16 mg) showing additional weight reduction.
Study context
- Population
- Adults aged 18–75 years without T2D, with BMI ≥30 kg/m² or 27 to <30 kg/m² with ≥1 weight-related comorbidity, USA; mean age 47.7 years (SD 12.3), 66% femalerandomised 3:2:3:3
- Participants
- 179 adults
- Comparison
- Once-weekly subcutaneous mazdutide vs placebo for 48 weeks
- Mazdutide 3-6 mgn = 32
- Mazdutide 10 mgn = 48
- Mazdutide 16 mgn = 51
- Placebon = 48reference
- Primary endpoint
- Percentage change in bodyweight from baseline (efficacy [hypothetical] estimand)
- Follow-up
- 32 weeks
Methodological detailsdouble-blind, placebo-controlled, phase 2, multicentre, 24 centres in the USA
- Double-blind
- Placebo-controlled
- Phase 2
- Multicentre
- 24 centres in the USA
Primary result
As reported in the abstract
Least-squares mean percentage change from baseline in bodyweight
Estimated treatment difference
−6.5% to −17.2%
P < 0.0001, all comparisons
Change by group
Mazdutide 3-6 mg
−7.3
least-squares mean · SE 0.9 · %
Mazdutide 10 mg
−15.6
least-squares mean · SE 0.7 · %
Mazdutide 16 mg
−18.1
least-squares mean · SE 1.0 · %
Placebo
−0.9
least-squares mean · SE 0.8 · %
Further findings
- Additional bodyweight reductions were observed at 48 weeks
Safety
Adverse events
- Discontinuation due to AEs, most frequent with 16 mg, primarily gastrointestinal disorders
- 20%
- Most common AEs with mazdutide were gastrointestinal-related, mostly mild to moderate
Original publication
Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial. Lancet Diabetes Endocrinol. Published 21 August 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →