BGM0504 / BrightGene Bio-Medical - LARVOL DELTA

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

BGM1812, a Novel Amylin Analog, Enhances Receptor Agonism and Induces Superior Weight Loss in Preclinical Models (ADA 2025) - "Introduction and Objective: Amylin receptor agonists (e.g. petrelintide and cagrilintide) have shown promise for weight management...This study evaluates BGM1812's pharmacological properties, weight loss efficacy, and potential synergy with a GLP-1/GIP dual agonist (BGM0504) in diet-induced obese (DIO) rats. Receptor activation: cAMP assays measured EC50 for amylin and calcitonin receptor activation... BGM1812 demonstrates superior receptor activation, robust weight loss effects, and synergistic potential with GLP-1/GIP dual agonism, supporting its development as a next-generation amylin analog for obesity treatment."

Late-breaking abstract • Preclinical • Metabolic Disorders • Obesity

Efficacy and Safety of BGM0504 in Chinese Patients with Type 2 Diabetes—A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Semaglutide Positive-Controlled Phase 2 Trial (ADA 2025) - P2a | "BGM0504 was safe and well-tolerated, with the 15 mg dose showing the most substantial effects. It is a promising treatment option for improving glycemic control and achieving weight reduction in patients with T2DM."

Clinical • P2 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of BGM0504 in Chinese Patients with Obesity—A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial (ADA 2025) - P2 | "BGM0504 demonstrates significant potential for weight management and metabolic risk reduction in overweight and obese non-diabetic individuals."

Clinical • P2 data • Metabolic Disorders • Obesity

BGM1812 Preclinical Study (PRNewswire) - "BrightGene presents...preclinical data for novel amylin analog at American Diabetes Association's 85th Scientific Sessions....In a preclinical study, BGM1812 demonstrated strong receptor activation with 1.8× and 2.2× increased agonist activity (EC50) at the amylin and calcitonin receptors, respectively, versus petrelintide. The agonist also demonstrated dose-dependent weight loss in 0.012 - 0.12 mg/kg dose range in the diet-induced obese (DIO) rat model. At 0.04 mg/kg, BGM1812 achieved greater weight reduction than petrelintide. In addition, BGM1812 significantly preserved relative lean mass while reducing relative fat mass. Additionally, the combination of BGM1812 and BGM0504 resulted in greater and more sustained weight loss than either semaglutide+cagrilintide or amycretin in the DIO rat model."

Preclinical • Obesity

BGM0504 Phase 2 Study in Obesity (PRNewswire) - P2 | N=120 | NCT06973681 | Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | "BrightGene presents positive phase 2 data for dual GLP-1R/GIPR agonist...at American Diabetes Association's 85th Scientific Sessions....This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of BGM0504 in 120 Chinese adults with obesity during multiple-dose administration (subcutaneous injection)....Study results demonstrated reductions in waist circumference ranging from −8.0 cm to −12.98 cm (p < 0.001), and significant weight reductions ranging from -10.77% to 19.78% (LS means, placebo adjusted). Results also showed improvements in systolic blood pressure ranging from −11.60 to −13.03 mmHg and diastolic blood pressure ranging from −5.98 to −7.50 mmHg (p < 0.05). Secondary outcomes further supported the efficacy of BGM0504, and all doses were well tolerated with common adverse events."

P2 data • Obesity

A Study of BGM0504 in Chinese Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

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

New P1 trial • Obesity

A Study of BGM0504 in Participants With Obesity (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

Borri Pharmaceuticals initiates Phase II weight loss study of BGM0504 vs tirzepatide [Google translation] (bydrug.pharmcube.com) - "On March 21, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Borrui Pharmaceuticals launched a Phase II weight loss clinical trial comparing BGM0504 with tirzepatide....The primary endpoint of the study is the relative percentage change in patient weight compared to baseline at week 26."

Trial status • Obesity

The safety, tolerability, pharmacokinetics and pharmacodynamics of an optimized dual GLP-1/GIP receptor agonist (BGM0504) in healthy volunteers: A dose-escalation Phase I study. (PubMed, Diabetes Obes Metab) - "BGM0504 was generally safe and well tolerated with favourable PK profile and potential role in weight loss was also confirmed. These findings support subsequent development of BGM0504 for type 2 diabetes mellitus (T2DM) and obesity."

Clinical • Journal • P1 data • PK/PD data • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus