Development

BrightGene posts 19.3% weight reduction in Phase III obesity trial for GLP-1/GIP injection

Edited by Robert McTiernan··2 min read

BrightGene Bio-Medical Technology Co., Ltd. (688166.SH) reported that BGM0504, its GLP-1/GIP dual receptor agonist, reduced body weight by a mean of 19.3% in a Phase III trial in participants with overweight or obesity, with the study meeting its primary endpoint and all key secondary endpoints.

The BGM0504-III-WL study is a multicenter, randomized, double-blind, placebo-controlled Phase III trial conducted across 41 sites in China, enrolling 652 adults with overweight or obesity over a 52-week treatment period.

At the 15 mg dose, BGM0504 produced a mean body weight reduction of 19.2% from baseline in the total randomized population (19.3% in the per-protocol population), compared with 3.1% for placebo. Nearly half of participants in the 15 mg group — 48.9% — achieved at least 20% weight loss, and 67.3% achieved at least 15%. Mean waist circumference fell by 16.5 cm versus 3.3 cm with placebo. In a subset of participants with baseline hypertension and inadequately controlled blood pressure, systolic and diastolic blood pressure decreased by 22.9 mmHg and 12.9 mmHg respectively after 36 weeks, with 92.9% reaching blood pressure target. Across all dose groups pooled, triglycerides fell by 33.6%, LDL cholesterol by 12.7%, and uric acid by a mean of 70.7 µmol/L. Discontinuation due to adverse events was 0.7% in the 15 mg group over 52 weeks.

BGM0504 is a subcutaneously administered dual agonist of the glucagon-like peptide-1 receptor and the glucose-dependent insulinotropic polypeptide receptor — the same mechanistic class as Eli Lilly's Zepbound (tirzepatide), which BrightGene has selected as the active comparator in an ongoing Phase II obesity trial (NCT06911203). That trial design choice positions tirzepatide as the most direct benchmark for BGM0504 within its own development program. Cross-trial comparisons are limited by differences in population, dosing schedules, and study design, but the 19.3% mean weight reduction reported here sits within the range observed with tirzepatide in the SURMOUNT program. Whether BGM0504 offers a differentiated profile will depend on head-to-head data rather than cross-study inference.

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The cardiometabolic secondary findings — particularly the blood pressure reduction in the hypertensive subgroup and the uric acid data — are directionally consistent with what has been observed across the incretin class, though the magnitude of the blood pressure effect in the hypertensive subset warrants attention given that participants were largely free of antihypertensive medications during the study. Bone mineral density, often a concern with substantial weight loss, did not decline; total body, lumbar spine, and hip bone mineral density increased by 0.3%, 1.4%, and 3.9% respectively across pooled treatment groups, a finding BrightGene highlights as potentially differentiating but one that requires longer-term data to interpret fully.

BrightGene said it plans to submit a New Drug Application to China's National Medical Products Administration for BGM0504 for chronic weight management, with no specific timeline disclosed.

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