Kailera Therapeutics (Nasdaq: KLRA) reported positive topline data from two Hengrui Pharma-sponsored Phase III trials of HRS-7535 (safiglipron), an oral small molecule GLP-1 receptor agonist, advancing what has become one of the more closely watched programs in the oral obesity and diabetes space. The results, generated in China and covering both obesity and type 2 diabetes, provide the first substantial efficacy and safety readout for the molecule that Kailera licensed from Hengrui for development outside Greater China in 2024.
In the Phase III HARBOR-1 obesity trial, adults receiving HRS-7535 achieved mean weight loss of 9.8% at the 180 mg dose after 44 weeks, compared with 2.4% for placebo, meeting the study's primary endpoint. Gastrointestinal adverse events, including nausea and vomiting, were common, although treatment discontinuation rates remained low and no liver safety signal was observed.
The OUTSTAND-2 Phase III trial enrolled patients with type 2 diabetes inadequately controlled on metformin. All three HRS-7535 dose groups met the primary endpoint of non-inferiority to AstraZeneca's Farxiga (dapagliflozin) for HbA1c reduction, while the highest dose demonstrated statistical superiority, lowering HbA1c by 1.68% versus 1.28% with dapagliflozin.
The results strengthen Kailera's global development program for the molecule, known outside Greater China as KAI-7535. The company's Phase II study, launched in the US and Australia in April 2026, is evaluating slower dose escalation and higher doses in an effort to improve tolerability while maintaining or enhancing efficacy.