BrightGene's oral BGM0504 shows dose-dependent weight loss in Phase I obesity trials

BrightGene Bio-Medical Technology (SSE: 688166), based in Suzhou, China, reported topline Phase I results for [BGM0504](https://www.prnewswire.com/news-releases/brightgene-announces-positive-topline-phase-1-results-of-oral-bgm0504-in-obesity-in-china-and-the-united-states-302724483.html), an oral GLP-1/GIP dual receptor agonist, in adults with overweight or obesity and in healthy volunteers, according to data from two separate studies conducted in China and the United States. The company said BGM0504 was generally well tolerated across both trials, with no serious adverse events reported, and that preliminary efficacy analyses showed dose-dependent reductions in body weight. In the China study ([NCT07239973](https://clinicaltrials.gov/ct2/show/NCT07239973)), a randomized, double-blind, placebo-controlled trial enrolling 75 participants, once-daily oral doses of 10 mg to 80 mg over four weeks produced mean body weight reductions of 1.0% to 5.6% (least squares mean) across dose groups on an intent-to-treat basis. Pharmacokinetic data indicated steady-state exposure was reached after two to three weeks, with dose-proportional increases in exposure. In the U.S. study ([NCT07166081](https://clinicaltrials.gov/ct2/show/NCT07166081)), a randomized, placebo-controlled, multiple ascending dose trial of 80 participants (64 on drug, 16 on placebo), doses of 20 mg to 80 mg administered once daily for five to eight weeks yielded mean weight reductions of 2.7% to 8.2%. Gastrointestinal adverse events in both studies were the most common findings and were described as mild to moderate and transient, consistent with the GLP-1 receptor agonist class. No dose-specific safety breakdowns, discontinuation rates, or placebo-arm weight change data were disclosed. The trials were designed to assess safety, tolerability, and pharmacokinetics, with efficacy as a preliminary endpoint. Primary endpoints were not formally specified in the company's disclosure. The China study was double-blind; blinding status for the U.S. study was not explicitly stated. BrightGene noted that results are based on preliminary analyses of ongoing studies and that interpretations may change as additional data become available. Detailed results are expected at a scientific conference later this year. The company did not disclose individual dose-level response data, statistical comparisons to placebo, or pharmacodynamic biomarker findings. BGM0504 is a dual GLP-1/GIP receptor agonist being developed in both oral and subcutaneous formulations. The oral obesity drug space includes several programs in clinical development; tirzepatide (Eli Lilly), an injectable GLP-1/GIP dual agonist, demonstrated approximately 20% mean body weight reduction at 72 weeks in the Phase III SURMOUNT-1 trial in obesity. Cross-trial comparisons are limited by differences in study design, duration, and patient populations. --- Spot something wrong? [Report an issue with this article](https://newsgen-prod.reframedata.com/feedback/bgm0504-weight-loss-brightgenes-oral-shows)