Mazdutide demonstrates weight-loss benefit in US cohort

Once-weekly, subcutaneous mazdutide treatment yields meaningful reduction in bodyweight in a US cohort of adults with obesity or overweight, according to a phase II study.

The phase II study included 179 adults (mean age 47.7 years, 66 percent female) without type 2 diabetes and with a BMI of at least 30 kg/m² or 27 to <30 kg/m² plus at least one weight-related comorbidity.

Participants were randomly assigned to receive once-weekly subcutaneous injections of placebo (n=48) or mazdutide at 3–6 mg (n=32), 10 mg (n=48), or 16 mg (n=51) for 48 weeks. Those assigned to 3–6 mg mazdutide maintained 3 mg from week 4 to week 32 before escalating to 6 mg at 32 weeks.

The primary endpoint was percentage change in bodyweight from baseline to 32 weeks. Safety was also evaluated.

At 32 weeks, the mean percentage change in bodyweight was significantly greater with mazdutide than with placebo: –7.3 percent with 3–6 mg, –15.6 percent with 10 mg, and –18.1 percent with 16 mg vs –0.9 percent (p<0.0001 for all comparisons). Additional bodyweight reductions were observed at 48 weeks among mazdutide-treated participants.

In the mazdutide groups, gastrointestinal-related adverse events (AEs) occurred frequently. These AEs were mostly mild to moderate in severity. AEs leading to treatment discontinuation occurred frequently in the 16-mg mazdutide group (20 percent), mainly attributed to gastrointestinal disorders.