Obesity

Mazdutide reduces body weight in adults with overweight or obesity: A high‐dose Phase 1 trial

Diabetes Obes MetabPublished Randomised controlled 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

OutcomeCohort 1Cohort 2PlaceboP 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 PlaceboP < 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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