Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight
Authors' conclusion
In Chinese adults with overweight or obesity, once-weekly mazdutide at a dose of 4 mg or 6 mg for 32 weeks led to clinically relevant reductions in body weight.
Study context
- Population
- Chinese adults 18 to 75 years with body-mass index (BMI) ≥28, or BMI 24 to <28 plus ≥1 weight-related coexisting condition; mean baseline body weight 87.2 kg, mean BMI 31.1randomized 1:1:1
- Participants
- 610 adults
- Comparison
- Once-weekly mazdutide 4 mg or 6 mg vs placebo for 48 weeks
- Primary endpoint
- Two primary end points: percentage change in body weight from baseline and weight reduction of ≥5% (treatment-policy estimand)
- Follow-up
- Week 32
Methodological detailsphase 3, double-blind, placebo-controlled
- Phase 3
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Percentage change in body weight from baseline; weight reduction ≥5% · week 32 4-mg mazdutide mean −10.09% (95% CI −11.15–-9.04) · 6-mg mazdutide mean −12.55% (95% CI −13.64–-11.45) · Placebo mean 0.45% (95% CI −0.61–1.52)
Weight reduction ≥5%
- 4-mg mazdutide vs Placebo: P < 0.001 for all comparisons with placebo
- 6-mg mazdutide vs Placebo: P < 0.001 for all comparisons with placebo
Further findings
Weight reduction ≥15% · week 48 — 4-mg mazdutide vs Placebo
P < 0.001 for all comparisons with placebo
Mean
| Outcome | 4-mg mazdutide | 6-mg mazdutide | Placebo | P value |
|---|---|---|---|---|
| Percentage change in body weight from baseline · week 484-mg mazdutide vs Placebo | −11.00% (95% CI −12.27–-9.73) | −14.01% (95% CI −15.36–-12.66) | 0.30% (95% CI −0.98–1.58) | P < 0.001 for all comparisons with placebo |
| Percentage change in body weight from baseline · week 486-mg mazdutide vs Placebo | P < 0.001 for all comparisons with placebo | |||
| Weight reduction ≥15% · week 486-mg mazdutide vs Placebo | P < 0.001 for all comparisons with placebo |
Prespecified cardiometabolic measures
- Beneficial effects on all prespecified cardiometabolic measures with mazdutide
Safety
Adverse events leading to discontinuation of trial regimen
Adverse events leading to discontinuation of trial regimen
- Most frequent adverse events were gastrointestinal, mostly mild to moderate
Original publication
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