Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China.
Kailera Therapeutics and Hengrui Pharma have claimed mid-stage victory for ribupatide, their investigational oral GLP-1/GIP receptor dual agonist, touting weight loss that topped 12% in adults with obesity. The results pave the companies’ path to Phase 3 development.
The companies are running a Phase 2 study in China that enrolled 166 patients with obesity who were randomly assigned to one of three ribupatide doses—10 mg, 25 mg or 50 mg—or placebo. After 26 weeks of follow-up, the two higher drug doses elicited a mean 12.1% weight reduction from baseline, whereas those on placebo lost 2.3% of their body weight.
Kailera and Hengrui had not documented a plateauing effect at the time of the topline readout, according to their Tuesday news release.
Moreover, 59.1% of patients in the 25-mg arm achieved at least a 10% reduction in weight, while 38.6% hit at least 15% weight loss at 26 weeks. These percentages were slightly lower for the 50-mg dose: 52.5% had a 10% reduction, and 37.5% lost 15% of their body weight at week 26.
As for safety, the partners called the overall adverse event profile “favorable,” with low rates of gastrointestinal toxicities. Nausea and vomiting hit 22.7% and 11.4% in the 25-mg group, respectively, and dipped to 20% and 7.5% in the 50-mg arm. Kailera and Hengrui did not have to permanently discontinue treatment or lower dosage in any patients due to side effects.
With these data in hand, Hengrui plans to take ribupatide into late-stage development in China. Kailera, meanwhile, will launch a global Phase 2 study for the drug this year.
Currently, the oral obesity space is led by Novo Nordisk, which last year won FDA approval for a pill version of Wegovy, which it launched last month. Close on its heels is Eli Lilly and its oral asset orforglipron, for which it expects a regulatory verdict in April.
Both Wegovy and orforglipron are mono-agonists that activate only the GLP-1 pathway. Ribupatide, designed to be taken orally once daily—though a weekly injectable version is also in the works—targets both the GLP-1 and GIP receptors.
The drug also has a longer half-life in the body and results in greater exposure versus “a leading obesity medication,” Kailera noted on its website, though it did not reveal which drug it used as a comparator.
