BGM1812 / BrightGene Bio-Medical - LARVOL DELTA

BrightGene Secures NMPA Nod for BGM1812 Obesity Trial, FDA Grants Trial Clearance (flcube.com) - "Phase I/II (China) - enrollment to begin Q1 2026, focusing on safety, pharmacokinetics, and dosing in adults with BMI ≥ 25 kg/m². Phase I (U.S.) - early‑phase study underway; primary objectives: safety, tolerability, dose‑response, and preliminary efficacy in the U.S. obesity population."

IND • New P1/2 trial • Trial status • Obesity

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

Discovery of BGM1812, a Novel Dual Amylin and Calcitonin Receptor Agonist for Obesity Treatment. (PubMed, J Med Chem) - "In both in vivo and in vitro studies, BGM1812 showed significantly enhanced efficacy. This finding provides valuable insights into the SAR of petrelintide and highlights the potential of BGM1812 as a promising obesity drug candidate."

Journal • Genetic Disorders • Obesity

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