Hengrui, Kailera’s GLP‑1 Pill Posts Encouraging Efficacy but High Side Effect Rates in Late‑Stage China Trials

Hengrui and Kailera’s oral GLP-1 pill, HRS-7535 (KAI-7535), has met its main endpoints in two late‑stage China trials for obesity and type 2 diabetes, supporting a planned regulatory submission in China but raising concerns about tolerability.

In the obesity trial HARBOR‑1, patients receiving 120 mg and 180 mg of HRS‑7535 lost 8% and 9.8% of their body weight at week 44 versus 2.4% on placebo.

In the diabetes trial OUTSTAND‑1/‑2, the highest HRS‑7535 dose (90 mg) reduced HbA1c by 1.68%, compared with 1.28% for dapagliflozin (Farxiga), demonstrating non‑inferior glycemic control.

About 70% of patients on HRS‑7535 experienced nausea and up to 68.6% reported vomiting, both far higher than placebo rates (16.2% and 4.5%, respectively), though most adverse events were mild to moderate and no liver safety signal was seen.

Analysts note that the high gastrointestinal side‑effect rates may complicate the ongoing U.S. development program for this oral GLP‑1 candidate.