ZT003 / Beijing QL Biopharma - LARVOL DELTA

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Beijing QL Biopharmaceutical Co.,Ltd | Trial completion date: Oct 2026 ➔ Apr 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Obesity

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Beijing QL Biopharmaceutical Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Obesity

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Beijing QL Biopharmaceutical Co.,Ltd

New P1 trial • Obesity

Another one: GLP-1/FGF21 dual agonist approved for clinical trials in the United States [Google translation] (163.com) - "Recently, the innovative GLP-1/FGF21 dual agonist ZT003 injection independently developed by Beijing Zhipeptide Biotechnology Co., Ltd. has officially obtained approval for new drug clinical trials from the U.S. Food and Drug Administration (FDA). Its indication is the treatment of metabolic dysfunction-associated fatty liver disease (MASH). ZT003 is about to conduct Phase I clinical trials abroad."

IND • New P1 trial • Metabolic Dysfunction-Associated Steatotic Liver Disease

A novel GLP-1/FGF21 dual agonist ZT003 has therapeutic potential for obesity, MASH and SHTG (EASD 2024) - "When tested in DIO obese mice and db/db diabetic obesity mice, ZT003 demonstrated synergistic, sustained, and superior body weight reduction and glucose-lowering effect versus semaglutide, tirzepatide and YH25724... In conclusion, this novel GLP-1/FGF21 fusion protein in animals reveals therapeutically efficacious to treat obesity, MASH and SHTG, thus demonstrating the promise of the poly-pharmaceutical approach in metabolic drug discovery and development."

Late-breaking abstract • Diabetes • Hypertriglyceridemia • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Type 2 Diabetes Mellitus • FGF21 • KLB