China-based Hengrui Pharmaceuticals has announced positive top-line results from the Phase III HARBOR-1 study evaluating its oral, once-daily small-molecule GLP-1 receptor agonist, safiglipron, for weight management in adults with obesity or overweight. At week 44, the 120 mg and 180 mg arms achieved mean weight reductions of 9.5% and 10.9% respectively versus 2.5% for placebo (effectiveness estimand), with 68.2% of patients in the 180 mg arm achieving ≥5% weight loss. Improvements were also observed in glycaemic control, systolic blood pressure, and lipid parameters. The safety profile was consistent with the GLP-1 class, with mostly mild-to-moderate gastrointestinal adverse events and low discontinuation rates.

Based on these data, Hengrui intends to file a New Drug Application (NDA) in China for the obesity indication in 2026. Kailera Therapeutics, which holds ex-Greater China rights, initiated a global Phase II trial for safiglipron in obesity in April 2026, with data expected in 2027. Safiglipron is also in Phase III development for type 2 diabetes (OUTSTAND series) and is being studied in chronic kidney disease, highlighting its potential across cardio-metabolic indications.

According to PharmCube's NextBiopharm® database, this result positions safiglipron as a strong contender against Eli Lilly's orforglipron, the only oral GLP-1 drug in the market. Click here to request a free trial for NextBiopharm®.