Study summary · research use only
Mazdutide reduces body weight in adults with overweight or obesity: A high-dose Phase 1 trial
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This randomised, double-blind, placebo-controlled Phase 1 trial in Thirty-two adults with overweight or obesity without diabetes evaluated mazdutide, an agonist of glucagon-like peptide-1 and glucagon receptors, at doses up to 16 mg over 20 weeks, using two dose-escalation regimens (n = 12 each) versus placebo (n = 8). At Week 20, mean percent weight loss was -20.0% and -21.0% for the two mazdutide cohorts versus -0.1% for placebo (p < 0.001); weight loss of at least 15% was achieved by 66.7% and 75.0% of the two cohorts, versus no placebo participants achieving at least 5% weight loss. Waist circumference changes were -12.0% and -17.0% for mazdutide cohorts versus -0.8% for placebo. No serious adverse events were reported; the most common adverse events were mild or moderate gastrointestinal disorders.
Abstract
Mazdutide, an agonist of glucagon-like peptide-1 and glucagon receptors, significantly reduced weight in early phase trials at doses up to 10 mg. This randomized, double-blind, placebo-controlled Phase 1 trial evaluated the safety and efficacy of mazdutide up to 16 mg in adults with overweight or obesity. Thirty-two adults with overweight/obesity without diabetes received once-weekly subcutaneous injections of mazdutide (n = 24) or placebo (n = 8) for 20 weeks. Two mazdutide dose escalation regimens (Cohorts 1 and 2, n = 12 each) were used to reach a 16-mg target dose. Data were analysed using descriptive statistics and mixed model repeated measures to estimate least square means with standard error (SE). At Week 20, mean percent change from baseline in body weight was -20.0% (SE: 1.9) for Cohort 1 and -21.0% (1.2) for Cohort 2 versus -0.1% (1.5) for placebo (p < 0.001). Weight loss of ≥15% was achieved by 66.7% of Cohort 1 and 75.0% of Cohort 2. No placebo participants achieved ≥5% weight loss. Mean percent change in waist circumference was -12.0% (SE: 1.7) in Cohort 1 and -17.0% (1.7) in Cohort 2 versus -0.8% (2.1) in placebo (p < 0.001). Improved fasting metabolic biomarker profiles and reduced appetite were associated with mazdutide treatment. No serious adverse events (AEs) were reported, and the most common AEs were mild or moderate gastrointestinal disorders. 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. US Clinical Trials Registry: NCT05623839.
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