Kailera Therapeutics announced completion of enrollment in the KaiNETIC global Phase 3 program evaluating ribupatide injection (KAI-9531) for people with obesity or overweight.
The program comprises three double-blind, randomized, placebo-controlled trials: KaiNETIC-1 (approximately 2,500 adults with a BMI of 30 kg/m2 or greater, or 27 kg/m2 or greater with a comorbidity, excluding type 2 diabetes), KaiNETIC-2 (approximately 1,200 adults with a BMI of 27 kg/m2 or greater and type 2 diabetes) and KaiNETIC-3 (approximately 1,200 adults with a BMI of 35 kg/m2 or greater without type 2 diabetes), which enrolled at more than 200 sites across 11 countries in North America, Europe, the United Kingdom, Oceania and South America.
The trials evaluate once-weekly subcutaneous doses up to 10 mg administered over 76 weeks with up to 24 weeks of dose titration and at least 52 weeks of maintenance; primary endpoints include percentage change in body weight at Week 76.
KaiNETIC-2 also measures hemoglobin A1c, and KaiNETIC-3 compares weight loss to semaglutide 2.4 mg, according to the company.
Ribupatide has been studied in more than 3,000 participants for up to 52 weeks in trials conducted by Hengrui in China.
Hengrui has submitted a regulatory filing to the NMPA and granted Kailera exclusive rights outside Greater China in May 2024, the company claims.
opline data are now expected in mid-2028.
