Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.
This Phase III randomized controlled trial evaluated mazdutide, a novel once-weekly dual glucagon and GLP-1 receptor agonist, compared to dulaglutide in 731 Chinese adults with type 2 diabetes (T2D) on background oral anti-diabetic therapy. Participants were randomized 1:1:1 to one of two mazdutide doses or dulaglutide (1.5 mg) for 28 weeks. The study found that both mazdutide doses demonstrated non-inferiority and superiority to dulaglutide in reducing HbA1c from baseline, with least-squares mean treatment differences of -0.24% and -0.30% for the lower and higher doses, respectively. Mazdutide also produced significantly greater reductions in body weight than dulaglutide, with differences of -3.78% and -5.76% for the two doses. The safety profile was generally acceptable, though gastrointestinal adverse events occurred more frequently with mazdutide than dulaglutide. Limitations include the relatively short 28-week duration, restriction to a Chinese population, and the lack of a placebo arm, which may limit generalizability of findings.
Why this grade: This is a Phase III RCT in 731 human participants with active comparator control, but evidence is graded moderate rather than strong due to the single-ethnicity sample, relatively short 28-week follow-up, and absence of a placebo arm.
Mazdutide is a once-weekly glucagon and glucagon-like peptide 1 receptor dual agonist developed for the treatment of type 2 diabetes (T2D) 1 . Here we report on a randomized phase III trial assessing the efficacy and safety of mazdutide, compared with dulaglutide, in participants with T2D who were also treated with background oral anti-diabetic drugs. In this study, 731 participants with T2D were randomized 1:1:1 to receive 4 mg mazdutide, 6 mg mazdutide or 1.5 mg dulaglutide for 28 weeks. Both doses of mazdutide showed non-inferiority and superiority to the 1.5-mg dose of dulaglutide in terms of the mean change in the diagnostic marker glycated haemoglobin A1c (HbA 1c ) from baseline to week 28, with a least-squares mean treatment difference of -0.24% (P = 0.0032) for 4 mg mazdutide and -0.30% (P = 0.0003) for 6 mg mazdutide, relative to 1.5 mg dulaglutide. Significantly greater reductions in body weight were achieved with mazdutide than with dulaglutide, with a least-squares mean treatment difference of -3.78% for 4 mg mazdutide and -5.76% for 6 mg mazdutide (both P 1c 1c and body weight that were superior to those attained with 1.5 mg dulaglutide. Mazdutide was generally safe, although the incidence of gastrointestinal adverse events was higher for mazdutide than for dulaglutide.
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