BGM0504 / BrightGene Bio-Medical - LARVOL DELTA

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

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

Enrollment closed • Obesity

A Study of BGM0504 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=537 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

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

A Study of BGM0504 Injection in Participants with Obesity or Overweight (clinicaltrials.gov) - P3 | N=620 | Recruiting | Sponsor: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

New P3 trial • Genetic Disorders • Metabolic Disorders • Obesity

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise (clinicaltrials.gov) - P3 | N=207 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P3 trial • 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 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P1 trial • Obesity

IIT study on BGM0504 injection therapy for T2DM combined with obesity (ChiCTR) - P=N/A | N=63 | Not yet recruiting | Sponsor: Ciming Boao International Hospital; Ciming Boao International Hospital

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

Molecular dynamics-guided optimization of BGM0504 enhances dual-target agonism for combating diabetes and obesity. (PubMed, Sci Rep) - "The results of both in vitro and in vivo experiments demonstrated that the optimized peptide has twofold to threefold increase in agonistic activity compared to Tirzepatide while maintaining its extended half-life in plasma. This led to the design of BGM0504, which proved to be more effective than its predecessor, Tirzepatide, in both laboratory and animal studies."

Journal • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of an Optimized Dual GLP-1/GIP Receptor Agonist (BGM0504) in Healthy Subjects—A Phase Ia, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study (ADA 2024) - "Background: BGM0504 is an optimized dual GIP and GLP-1 receptor agonist with greater in vitro potency, and similar GLP-1R/GIPR activity ratio as Tirzepatide. BGM0504 was well tolerated with favorable PK profile and led to evident body weight loss. These data support further clinical developments of BGM0504 for T2DM and obesity. The phase II clinical trials for both T2DM and obesity are ongoing, and available results will be presented."

Clinical • PK/PD data • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Borui Pharmaceuticals plans to add 350 million units of under-development weight loss drug production capacity [Google translation] (China Economic Net (CE.cn)) - "China Securities Network New...The Suzhou Industrial Park Management Committee website recently published the 'Environmental Impact Report of the Chemical Preparation Renovation Project of Borui Pharmaceutical (Suzhou) Co., Ltd'. The 'Report' shows that Borui Pharmaceuticals plans to add 350 million units/year of BGM0504 injection production capacity, with a total of 3 production lines, for the purpose of "lowering blood sugar and losing weight."

Commercial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Borui Medicine: BGM0504 injection has obtained ethics approval for phase II clinical trials for two indications: weight loss and type 2 diabetes treatment. [Google translation] (jrj.com) - "...Borui Pharmaceuticals stated on the interactive platform that the company's BGM0504 injection for weight loss and type 2 diabetes treatment has obtained ethics approval for Phase II clinical trials. Phase II clinical progress is normal and enrollment has begun."

Enrollment status • Trial status • Diabetes • Idiopathic Pulmonary Fibrosis • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Borui Pharmaceuticals: Subsidiary’s polypeptide antidiabetic drug BGM0504 injection is still in the research and development stage [Google translation] (STCN) - "The company’s holding subsidiary Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd. independently developed the peptide hypoglycemic drug BGM0504 injection....As of the disclosure date of this announcement, the two indications of weight loss and type 2 diabetes treatment have only obtained ethics approval for phase II clinical trials, of which phase II clinical trials for type 2 diabetes treatment have begun to enroll."

Enrollment open • New P2 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus