Mazdutide reduces body weight in adults with overweight or obesity: A high‐dose Phase 1 trial
Authors' conclusion
Mazdutide at 16 mg was well tolerated and associated with greater weight loss at higher doses than previously studied and improved metabolic regulation in adults with overweight or obesity.
Study context
- Population
- Adults with overweight/obesity without diabetes
- Participants
- 32 adults
- Comparison
- Once-weekly SC mazdutide up to 16 mg vs placebo
- Cohort 1n = 12
- Cohort 2n = 12
- Placebon = 8reference
Methodological detailsdouble-blind, placebo-controlled, phase 1
- Double-blind
- Placebo-controlled
- Phase 1
Primary result
As reported in the abstract
Mean percent change from baseline in body weight · Week 20
Cohort 1
−20.0
mean · SE 1.9 · %
Cohort 2
−21.0
mean · SE 1.2 · %
Placebo
−0.1
mean · SE 1.5 · %
Cohort 1 vs Placebo: P < 0.001 · Cohort 2 vs Placebo: P < 0.001
Further findings
| Outcome | Cohort 1 | Cohort 2 | Placebo | P value |
|---|---|---|---|---|
| Weight loss ≥15% | 66.7% | 75.0% | — not stated in the abstract | |
| Mean percent change in waist circumferenceCohort 1 vs Placebo · % | −12.0 (SE 1.7) | −17.0 (SE 1.7) | −0.8 (SE 2.1) | P < 0.001 |
| Mean percent change in waist circumferenceCohort 2 vs Placebo | P < 0.001 |
— not stated in the abstract
Weight loss ≥15%
- No placebo participants achieved ≥5% weight loss
Metabolic biomarkers and appetite
- Improved fasting metabolic biomarker profiles and reduced appetite associated with mazdutide
Safety
Adverse events
- Serious adverse events (AEs)
- 0
- Most common AEs were mild or moderate gastrointestinal disorders
Original publication
Mazdutide reduces body weight in adults with overweight or obesity: A high‐dose Phase 1 trial. Diabetes Obes Metab. Published 20 August 2025. doi:10. 1111/ dom. 70040
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