Kailera Therapeutics Announces Positive Topline Data from Two Hengrui Pharma Phase 3 Clinical Trials of Oral Small Molecule GLP-1 Receptor Agonist HRS-7535/KAI-7535
Kailera Therapeutics announced positive topline Phase 3 data from Hengrui Pharma for its oral small molecule GLP-1 agonist KAI-7535, showing up to 11.1% mean weight loss at week 50 in the HARBOR-1 obesity trial. In the OUTSTAND-2 Type 2 diabetes trial, the 90 mg dose achieved a 1.68% reduction in HbA1c, demonstrating superiority over the 1.28% reduction seen with dapagliflozin. Safety data showed no liver safety signals, though gastrointestinal adverse events were common, with approximately 70% of participants reporting nausea and vomiting. Kailera is currently conducting a global Phase 2 trial of KAI-7535 in the U.S.
Key figures
- Drug Name
- HRS-7535 (KAI-7535)
- Phase Of Trial
- Phase 3
- Nausea rate 180mg
- 70.0%
- Vomiting rate 180mg
- 68.6%
- Hba1c reduction 90mg
- 1.68%
- Patients obesity trial
- 556
- Patients diabetes trial
- 810
- Weight loss week 44 180mg
- 10.9%
- Weight loss week 50 180mg
- 11.1%
- Hba1c reduction comparator dapagliflozin
- 1.28%
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