Slide 1: Oral small-molecule GLP-1 receptor agonist safiglipron (HRS-7535) in early type 2 diabetes
Oral small-molecule GLP-1 receptor agonist safiglipron (HRS-7535) in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial Miao Yu¹#, Zi Ye², Liang Peng², Yimei Xu², Fangli Dong², Yanlin Ma², Xinhua Xiao¹*, on behalf of the OUTSTAND-1 Study Group ¹Department of Endocrinology, P
Slide 2: Study Design and Baseline Characteristics
Study Design and Baseline Characteristics Background: Safiglipron (HRS-7535) is a once-daily oral small-molecule GLP-1 receptor agonist administered without fasting or dietary restrictions. Design: Phase 3, multicenter, randomized, double-blind, placebo-controlled trial at 46 sites in China. Populat
Slide 3: Efficacy outcomes
Efficacy outcomes Placebo safiglipron 30 mg safiglipron 60 mg safiglipron 90 mg A HbA1c change at Week 32 B HbA1c change through Week 52 C HbA1c target attainment at Week 32 Treatment-policy estimand Efficacy estimand Efficacy estimand Mean baseline HbA1c: 8.0% Mean baseline HbA1c: 8.0% D Bodyweight
Slide 4: Safety and Tolerability Profile
Safety and Tolerability Profile • Gastrointestinal events were the most common AEs, increased with dose, and were mostly mild or moderate. • No deaths, severe hypoglycemia, or Hy’s law cases occurred.
Slide 5: Conclusions
Conclusions • Once-daily oral safiglipron provided clinically meaningful glycemic control and bodyweight reductions, with improvements in indices of β-cell function and insulin sensitivity in adults with early type 2 diabetes. • Safiglipron was generally well tolerated, with a gastrointestinal toler
Slide 6: Oral safiglipron (HRS-7535) in diabetes: late-breaking abstract poster
Oral small-molecule GLP-1 receptor agonist safiglipron (HRS-7535) in early type 2 diabetes: LBA 39 a randomized, double-blind, placebo-controlled trial Miao Yu¹#, Zi Ye², Liang Peng², Yimei Xu², Fangli Dong², Yanlin Ma², Xinhua Xiao¹* | on behalf of the OUTSTAND-1 Study Group ¹Department of Endocrin