GZR18 is a glucagon-like peptide-1 receptor agonist under development for overweight/obesity. In this randomized, placebo-controlled phase 1b/2a trial in Chinese adults with overweight or obesity, different dose titration regimens and dosing frequencies (once-weekly QW vs. bi-weekly Q2W) are evaluated to assess safety and weight-loss efficacy over 26 weeks (Part A) or 35 weeks (Part B). Sixty participants are enrolled, of whom 46 complete the trial. The least-squares mean change in body weight is -9.36% for GZR18 vs. 6.68% for placebo in Part A and -17.8% (QW) and -12.8% (Q2W) for GZR18 vs. 0.7% for placebo in Part B; GZR18 also improves other weight-related and metabolic parameters. GZR18 is generally safe and well tolerated, with mostly mild-to-moderate gastrointestinal adverse events and no investigational-product-related serious adverse events reported. These findings warrant larger and longer trials of GZR18 for body weight management. The trial is registered at ClinicalTrials.gov (NCT06256536).
Ji et al. (Wed,) studied this question.