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June 7, 2026

2816-LB: Efficacy and Safety of Oral Ribupatide (HRS9531) in Adults with Obesity: A Phase 2 Trial

Key Points

This study aims to evaluate the efficacy and safety of oral ribupatide in adults with obesity who have no diabetes.
Participants with a BMI of 28−40 kg/m2 were randomized 1:1:1:1 to receive oral ribupatide (10, 25, or 50 mg) or placebo for 26 weeks.
Primary endpoint measured was the percentage change in body weight from baseline at week 26.
At week 26, ribupatide groups showed mean weight loss of 6.7%, 11.9%, and 11.4% for 10, 25, and 50 mg respectively, compared to 2.1% for placebo (p=0.0023, p<0.0001, p<0.0001).
77.5%, 59.1%, and 38.6% of participants achieved ≥5%, ≥10%, and ≥15% body weight reduction across ribupatide groups.
Ribupatide significantly improved waist circumference and blood lipid levels with mild gastrointestinal adverse events.

Abstract

Introduction and Objective: Ribupatide is a GLP-1/GIP receptor dual agonist peptide. QW injection of ribupatide demonstrated compelling weight loss in a Phase 3 trial. This study evaluated the efficacy and safety of oral ribupatide in adults with obesity and no diabetes. Methods: Participants (pts) with a BMI of 28−40 kg/m2 were randomized 1:1:1:1 to receive oral ribupatide (10, 25, or 50 mg) or placebo (PBO) for 26 weeks. The primary endpoint was the percentage change in body weight from baseline at W26. Results: The mean baseline body weight and BMI were 92.6 kg and 33.3 kg/m2. Based on treatment policy estimand at W26, LS mean weight loss from baseline were 6.7%, 11.9%, and 11.4% for ribupatide 10, 25, and 50 mg, compared to 2.1% for PBO (p=0.0023, p0.0001 and p0.0001). The ribupatide 50 mg group exhibited steeper weight loss compared to the 25 mg group after W8 without observed reduction plateau in both groups through W26. The proportion of pts achieving ≥5%, ≥10% and ≥15% body weight reduction was up to 77.5%, 59.1% and 38.6% across ribupatide groups. Additionally, all ribupatide groups outperformed PBO in reducing waist circumference, blood lipids, uric acid, and blood pressure. Most common gastrointestinal AEs with ribupatide were nausea, diarrhea, and vomiting, which were mostly mild/moderate in severity, none led to treatment discontinuation or down-titration. No AESI occurred. Conclusion: Oral ribupatide demonstrated significant weight loss in adults with obesity at W26 with no observed plateau and a favorable safety profile. Disclosure Y. Bi: None. D. Zhu: None. X. Li: None. S. Chen: None. Z. Ye: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Q. Zhou: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd. T. Xu: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd. F. Dong: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. L. Li: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. Funding Jiangsu Hengrui Pharmaceuticals Co., Ltd.

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