KAI-7535 (HRS-7535) - (HARBOR-1)

July 7, 2026: Kailera Therapeutics, Inc. announced positive topline results from two Phase 3 trials in China run by Hengrui Pharma for the oral small-molecule GLP-1 receptor agonist HRS-7535 (Kailera’s ex-Greater China version: KAI-7535), and reiterated its own ongoing global Phase 2 obesity study.

HARBOR-1 (NCT06904105; obesity/overweight): Met the primary endpoint (superior % weight reduction vs placebo at Week 44). Mean weight loss at Week 44 was 9.5% (120 mg) and 10.9% (180 mg) vs 2.5% placebo (efficacy estimand); 8.0% and 9.8% vs 2.4% (treatment policy estimand). Week 50 ad hoc efficacy analysis showed 9.5% and 11.1% vs 2.6% placebo. GI AEs were common; discontinuations due to TEAEs were 4.1% (120 mg) and 3.1% (180 mg) vs 2.7% placebo; no liver safety signal observed.

OUTSTAND-2 (NCT06589765; T2D on metformin): Met the primary endpoint (non-inferiority to dapagliflozin at Week 32 across 30/60/90 mg); 90 mg showed significant HbA1c reduction vs dapagliflozin. HbA1c reductions were 1.58%, 1.50%, 1.68% vs 1.28% (dapagliflozin). No grade 3 hypoglycemia; no liver safety signal.

Upcoming/regulatory: Hengrui plans to present full datasets at upcoming scientific conferences and submit NDAs in China for T2D and obesity. Kailera’s global Phase 2 obesity trial (initiated April 2026) expects data in 2027.