HRS-7535, an oral small-molecule GLP-1 receptor agonist, in Chinese adults with obesity without diabetes: a randomized, double-blind, placebo-controlled phase 2 trial - PubMed
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- #obesity treatment
- #clinical trial
- #GLP-1 receptor agonist
- HRS-7535 is an oral small-molecule GLP-1 receptor agonist investigated for weight loss in Chinese adults with obesity without diabetes.
- The phase 2 trial was randomized, double-blind, placebo-controlled, and involved 235 participants across 29 centers in China.
- Participants were assigned to once-daily doses of 30 mg, 60 mg, 120 mg, 180 mg, or placebo for 26 weeks.
- Primary endpoint was percentage body weight change from baseline to Week 26.
- At Week 26, weight reductions were dose-dependent: -2.99% (30 mg), -7.09% (60 mg), -6.17% (120 mg), -9.36% (180 mg) vs. -2.50% (placebo).
- Placebo-adjusted differences were statistically significant for 60 mg (-4.60%), 120 mg (-3.67%), and 180 mg (-6.87%) doses.
- Gastrointestinal adverse events were most common, mostly mild to moderate, and more frequent during dose escalation.
- HRS-7535 at 60 mg or higher produced clinically meaningful weight loss and was generally well tolerated.