BGM0504 / BrightGene Bio-Medical - LARVOL DELTA

A Study Comparing the Effects of BGM0504 Injection and Semaglutide Injection on Obese Subjects. (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Second Affiliated Hospital of Soochow University

New P2 trial • Genetic Disorders • Obesity

Effectiveness, Safety and Pharmacokinetics of BGM0504, a Dual GLP-1/GIP Receptor Agonist, in Chinese Adults With Overweight or Obesity Without Diabetes: A Phase 2 Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed, Diabetes Obes Metab) - P2 | "Once-weekly BGM0504 was associated with substantial dose-dependent weight loss and acceptable tolerability in Chinese adults with overweight or obesity without diabetes, supporting further clinical development."

Clinical • Journal • P2 data • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Efficacy and safety of BGM0504 in Chinese patients with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled Phase 3 trial (EASD 2026) - P3 | "Once-weekly BGM0504 demonstrated substantial and clinically meaningful reductions in body weight, together with favorable metabolic effects and an acceptable safety profile, in Chinese adults with overweight or obesity without diabetes. These findings support the potential of BGM0504 as a therapeutic option for chronic weight management."

Clinical • Late-breaking abstract • P3 data • Diabetes • Metabolic Disorders • Obesity

A Study of BGM0504 in Early T2DM With Obesity (clinicaltrials.gov) - P3 | N=372 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Obesity

Safety, Pharmacokinetics, and Weight Loss Effects of the Oral GLP-1/GIP Dual Agonist BGM0504 in Healthy and Overweight or Obese Adults: A Phase 1 Multiple-Ascending Dose Study (ADA 2026) - "Daily oral BGM0504 was generally well tolerated across all dose levels. The safety, tolerability, PK, and PD findings from this study support further clinical evaluation of oral BGM0504 as a potential treatment for obesity."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Metabolic Disorders • Obesity

GIP Moves from Supporting Role to Key Variable: BrightGene Bio-Medical’s Phase III Results Signal Differentiation in Weight Loss Arena (The Manila Times) - "Mean weight reduction of 19.3%, waist circumference decrease of 16.5 cm, systolic blood pressure reduction of 22.9 mmHg in the hypertensive population, alongside uric acid reduction of 70.7 μmol/L, triglyceride reduction of 33.6%, bone mineral density showing improvement rather than decline despite weight loss, and a discontinuation rate of 0.7% in the high-dose group."

P3 data • Obesity

CHINARES PHARMA...announced that the new drug application (NDA) for the innovative drug 'BGM0504 Injection', jointly developed by its subsidiary China Resources Sanjiu Medical & Pharmaceutical and BrightGene Bio-Medical Technology, for the weight loss indication has been officially accepted by the Center for Drug Evaluation of the National Medical Products Administration. (iis.aastocks.com)

China filing • Obesity

BGM2618, a Selective Myostatin Inhibitor, Preserves Lean Mass during GLP-1/GIP–Induced Weight Loss in Obese Mice (ADA 2026) - "In vivo efficacy was evaluated in DIO mice treated for 4 weeks with BGM0504 (0.15 mg/kg), a GLP-1/GIP dial agonist alone or in combination with BGM2618 (1 mg/kg), with comparison to the reference myostatin inhibitor 99m... BGM2618 is a potent and selective myostatin inhibitor that preserves lean body mass during GLP-1/GIP agonist-induced weight loss in obese mice, supporting its potential as an adjunct strategy to improve body composition during pharmacological weight management."

Preclinical • Metabolic Disorders • Obesity • TGFB1

Evaluation of the Safety, Efficacy and Pharmacokinetics of BGM0504 in Chinese Adults With Type 2 Diabetes: A Multicentre, Randomised, Controlled and Double-Blind Phase II Trial. (PubMed, Diabetes Obes Metab) - "BGM0504 shows a signal reduction for HbA1c, FPG, 2 h PG and body weight in Chinese adults with T2DM. The 12-week treatment with BGM0504 was safe and well-tolerated, with the 15 mg dose showing the most substantial effects."

Journal • P2 data • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of BGM0504 Tablets in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P1 trial

BGM0504 Achieves 19.3% Robust Weight Reduction, 16.5 cm Waist Circumference Decrease, Significant SBP/DBP Improvements of 22.9/12.9 mmHg, and 70.7 μmol/L Uric Acid Reduction; Phase III Trial Meets Primary Endpoint and All Key Secondary Endpoints (The Manila Times) - "The results from the total randomized population demonstrated that BGM0504 injection at doses of 5 mg, 10 mg, and 15 mg resulted in mean body weight reductions from baseline of 14.3%, 17.3%, and 19.2%, respectively, compared to 3.1% with placebo. The proportion of participants achieving ≥5% weight loss from baseline was 84.7%, 89.8%, and 94.6%, respectively. In the 15 mg dose group, 67.3% of participants achieved ≥15% weight loss from baseline, and 48.9% achieved ≥20% weight loss from baseline...Mean Systolic Blood Pressure Reduction of 22.9 mmHg, Mean Uric Acid Reduction of 70.7 μmol/L, and Mean Triglyceride Reduction of 33.6%...Common gastrointestinal adverse events were predominantly mild to moderate in severity and transient in nature, resolving spontaneously within a short period."

P3 data • Obesity

The U.S. Phase 1 study (NCT07166081) was a randomized, placebo-controlled, multiple ascending dose trial evaluating safety, tolerability and preliminary efficacy of BGM0504. (The Manila Times) - "BGM0504 was generally well tolerated, with no serious adverse events reported. The most commonly observed adverse events were gastrointestinal in nature, were generally mild to moderate, and were transient. Preliminary efficacy analyses demonstrated does response in weight reduction, with mean body weight reductions ranging from 2.7% to 8.2% (least squares mean) after five to eight weeks of treatment."

P1 data • Obesity

BrightGene Announces Positive Topline Phase 1 Results of Oral BGM0504 in Obesity in China... (The Manila Times) - "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 groups."

P1 data • Obesity

A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Bioequivalence Study of BGM0504 Injection (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P1 trial • Obesity

BGM0504-Ⅲ-T2DM-02-IDN: A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia (clinicaltrials.gov) - P3 | N=477 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | Trial completion date: Mar 2026 ➔ Jul 2026 | Trial primary completion date: Mar 2026 ➔ Jul 2026

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Obesity

Borri Biopharmaceuticals (Suzhou) Co., Ltd. Voluntarily Discloses Announcement Regarding the Approval Notice for Clinical Trial of BGM0504 Tablets [Google translation] (BrightGene Press Release)

New trial • Obesity

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P1 trial • Obesity

A Study of BGM0504 in Overweight or Obese Participants (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | Recruiting ➔ Completed

Trial completion • Obesity

A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia (clinicaltrials.gov) - P3 | N=477 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Borrui Pharmaceuticals: Signed a collaborative R&D agreement with China Resources Sanjiu for BGM0504 injection [Google translation] (Sina Corp) - "People's Finance News reported on August 1 that Borrui Pharmaceuticals...announced on the evening of August 1 that the company and its wholly-owned subsidiaries, Borri Pharmaceuticals and Borri New Biopharmaceutical Technology (Wuxi) Co., Ltd. (the three licensors are collectively referred to as 'Borui Pharmaceuticals and its affiliates') and China Resources SanjiuChina Resources Sanjiu Pharmaceutical Co., Ltd...has signed a 'Cooperative R&D Agreement' to cooperate on the research and development, registration, production and commercialization of BGM0504 injection in mainland China (excluding Hong Kong, Macau and Taiwan)."

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

Comments on the progress of Borri Pharmaceuticals' pipeline: BGM0504 tablets IND application accepted, rare dual-target oral peptides are about to enter clinical trials [Soochow Pharmaceuticals Zhu Guoguang Team] [Google translation] (Sohu.com) - "On July 10, the CDE official website announced that Borrui Pharmaceuticals' IND application for dual-target GLP-1/GIP receptor agonist BGM0504 tablets has been accepted."

New trial • Obesity • Type 2 Diabetes Mellitus