BrightGene Announces Positive Topline Phase 1 Results of Oral BGM0504 in Obesity in China and the United States

About this update from Brightgene Bio-medical Technology Co. Ltd. Class A

[{"type":"text","content":"BGM0504 shown to be generally well tolerated ","length":44,"tagName":"p","attribs":{}},{"type":"text","content":"Overall safety, pk, and efficacy profile supports once-daily oral dosing","length":72,"tagName":"p","attribs":{}},{"type":"text","content":"SUZHOU, China, March 25, 2026 /PRNewswire/ -- BrightGene Bio-Medical Technology Co., Ltd. (SSE: 688166, "BrightGene" or "the Company") today announced positive topline results from Phase 1 clinical studies of BGM0504, an investigational oral GLP-1/GIP dual receptor agonist, in adult participants in China and the United States, including healthy volunteers and individuals with overweight or obesity.","length":421,"tagName":"p"},{"type":"text","content":"Across both studies, BGM0504 was generally well tolerated, with no serious adverse events. Gastrointestinal adverse events, when observed, were predominantly mild to moderate in severity and transient, consistent with the known profile of this class. Preliminary efficacy results based on an intent-to-treat analysis showed meaningful reductions in body weight, with mean body weight reductions ranging from 1.0% to 5.6% after four weeks of treatment in the China study and from 2.7% to 8.2% after five to eight weeks of treatment in the U.S. study.","length":549,"tagName":"p"},{"type":"text","content":"The China Phase 1 study (CTR20253763 / NCT07239973) was a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGM0504 in healthy participants and non-diabetic individuals with overweight or obesity. A total of 75 participants were enrolled and completed the study. BGM0504 was administered once daily at doses ranging from 10 mg to 80 mg for four weeks. The compound was generally well tolerated across all dose levels, with no serious or unexpected adverse events reported. Gastrointestinal adverse events were mostly mild (Grade 1) and transient. Pharmacokinetic analyses showed that steady-state exposure was achieved after approximately two to three weeks of dosing and that exposure increased in a generally dose-proportional manner. After four weeks of treatment, participants receiving BGM0504 demonstrated reductions in body weight relative to baseline, with mean reductions ranging from 1.0% to 5.6% (least squares mean) across dose gr...

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