Ribupatide, An Oral Dual GLP-1/GIP, Achieves Weight Loss in Phase 2 Obesity Trial

Hengrui Pharma and Kailera Therapeutics have announced positive topline data from Hengrui’s phase 2 clinical trial of once-daily oral ribupatide (HRS9531 tablet; KAI-9531-T), a GLP-1/GIP receptor dual agonist peptide, in adults living with obesity in China.

As described in a February 10, 2026, press release, participants receiving oral ribupatide demonstrated a mean weight reduction from baseline of up to 12.1% at 26 weeks based on the efficacy estimand with no observed plateau in weight loss, and vomiting was reported in ≤ 11.4% of participants taking oral ribupatide.

“The Hengrui Phase 2 clinical trial results mark an important milestone in the expansion of our ribupatide franchise. We believe oral ribupatide could help to address the diverse needs of people living with obesity or overweight and meet patients wherever they are in their treatment journey,” Scott Wasserman, MD, Chief Medical Officer of Kailera, said in a statement. “These positive data suggest a potentially game-changing clinical profile for an oral obesity therapy, and we look forward to initiating a Phase 2 trial later this year. Concurrently, we intend to build upon the comprehensive injectable ribupatide data with the Phase 3 KaiNETIC program with the goal of rapidly and efficiently bringing more options to patients.”

Ribupatide is a GLP-1 receptor dual agonist peptide being developed as a once-weekly subcutaneous injection and as a once-daily oral tablet for the treatment of obesity and overweight. Once-weekly injectable ribupatide has been studied in > 2500 clinical trial participants who have been dosed with treatment out to 52 weeks, including in multiple late-stage clinical trials conducted by Hengrui in China. Hengrui submitted a marketing authorization application to the National Medical Products Administration in China for long-term weight management in adults.

In May 2024, Hengrui granted Kailera exclusive global rights outside Greater China to develop, manufacture, and commercialize its portfolio of innovative GLP‑1 therapeutics, including ribupatide. With these rights, Kailera is currently evaluating injectable ribupatide for the treatment of obesity in the KaiNETIC global phase 3 clinical program.

The HRS9531-T-201 clinical trial is a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial conducted by Hengrui in China to evaluate the efficacy and safety of oral ribupatide in adults ≥18 years of age living with obesity, defined as BMI ≥ 28 kg/m2, and without type 2 diabetes.

The study enrolled 166 participants who were randomly assigned in equal ratio to receive once-daily oral ribupatide 10 mg, 25 mg, 50 mg, or placebo. Participants followed a simple titration schedule, reaching the doses of 10 mg and 25 mg at week 4, and 50 mg at week 8. The primary objective was to evaluate the effect of oral ribupatide versus placebo on body weight at 26 weeks.

Based on the efficacy estimand at week 26, participants taking oral ribupatide achieved a mean weight loss of 6.9% (10 mg), 12.1% (25 mg), and 12.1% (50 mg) from baseline, with no observed plateau in weight loss, compared to 2.3% with placebo. Based on the treatment policy estimand at week 26, participants taking oral ribupatide achieved a mean weight loss of 6.7% (10 mg), 11.9% (25 mg), and 11.4% (50 mg) from baseline, with no observed plateau in weight loss, compared to 2.1% with placebo.

Additionally, at the 25 mg dose, 59.1% of participants achieved at least 10% weight loss, and 38.6% of participants achieved at least 15% weight loss at week 26. At the 50 mg dose, 52.5% of participants achieved at least 10% weight loss, and 37.5% of participants achieved at least 15% weight loss at week 26.

Results showed wral ribupatide demonstrated a favorable safety and tolerability profile, with most treatment-emergent adverse events (TEAEs) being mild to moderate and gastrointestinal (GI)-related. Rates of vomiting were 2.4% at 10 mg, 11.4% at 25 mg, and 7.5% at 50 mg while nausea was 11.9% at 10 mg, 22.7% at 25 mg, and 20.0% at 50 mg, consistent with the results of the trials previously conducted by Hengrui in China. No permanent treatment discontinuations or down-titrations due to nausea, vomiting, diarrhea, or constipation were reported in participants taking oral ribupatide.

“We are pleased to share these positive topline Phase 2 results for oral ribupatide. These data highlight the potential to deliver a differentiated oral medication for the treatment of obesity," Zi Ye, Senior Medical Director, Metabolic Diseases, Clinical Development, Hengrui Pharma, said in a statement. “We plan to rapidly advance to a Phase 3 clinical trial in China, bringing us a step closer to a potential new oral treatment option for people living with obesity.”

In addition to Hengrui’s plans to advance oral ribupatide to a phase 3 clinical trial for the treatment of obesity in China, Kailera plans to initiate a global phase 2 clinical trial in 2026. Hengrui additionally described intentions to share the full oral ribupatide phase 2 clinical trial data at an upcoming scientific conference.

References

1. Kailera Therapeutics. Kailera Therapeutics and Hengrui Pharma Report Positive Topline Data from Phase 2 Obesity Trial of Oral Ribupatide. February 10, 2026. Accessed February 10, 2026. https://www.kailera.com/press-release/kailera-therapeutics-and-hengrui-pharma-report-positive-topline-data-from-phase-2-obesity-trial-of-oral-ribupatide/

2. Kailera Therapeutics Announces First Participants Randomized in KaiNETIC Global Phase 3 Clinical Program of GLP-1/GIP Receptor Dual Agonist Ribupatide (KAI-9531). January 12, 2026. Accessed February 10, 2026. https://www.kailera.com/press-release/kailera-therapeutics-announces-first-participants-randomized-in-kainetic-global-phase-3-clinical-program-of-glp-1-gip-receptor-dual-agonist-ribupatide-kai-9531/