MWN109 / Minwei Biotech - LARVOL DELTA

Phase 2 Study of MWN109 Tablet for Weight-Loss Maintenance in Participants With Overweight or Obesity (clinicaltrials.gov) - P2 | N=71 | Active, not recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P2 trial • Genetic Disorders • Obesity

A Study to Evaluate Different Administration Conditions and the Food Effect of MWN109 Tablets in Chinese Participants (clinicaltrials.gov) - P1 | N=162 | Completed | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

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

Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

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

Phase Ib Clinical Study of MWN109 Injection in Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P1 trial • Genetic Disorders • Obesity

Phase 2 Study of MWN109 Tablet in Participants With Overweight or Obesity (clinicaltrials.gov) - P2 | N=255 | Completed | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P2 trial • Genetic Disorders • Obesity

Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P2 trial • Genetic Disorders • Obesity

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P2 trial • Genetic Disorders • Obesity

Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=98 | Completed | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P1 trial

Phase 1 Clinical Study of MWN109 Injection in Healthy Chinese Volunteers (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P1 trial

Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity (clinicaltrials.gov) - P3 | N=760 | Not yet recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P3 trial • Genetic Disorders • Obesity

Lepu Medical subsidiary Minwei Biotech's Phase I clinical trial data in China for its triple agonist MWN109 injection and oral tablets showed positive results. [Google translation] (Sina Corp) - "Data shows that both dosage forms demonstrated good safety and tolerability in their respective trials, and exhibited significant efficacy in weight loss. Specifically, in the Phase Ib trial of MWN109 injection in China, after 14 weeks of continuous administration to non-diabetic overweight/obese participants, the treatment group showed a maximum mean weight loss relative to baseline of 16.67%, significantly better than the 0.99% in the placebo group. Its Phase Ia trial also showed a maximum mean weight loss of 3.49% after a single dose, reaching 8.37% after multiple doses. In a Phase I trial in China, MWN109 oral tablets, administered once daily for four weeks, resulted in a mean weight loss of 4.18% to 7.82% within a dose range of 7.5 mg to 45 mg, demonstrating a dose-response relationship and showing better results than the placebo group."

P1 data • Obesity

A Study to Evaluate MWN109 Tablets in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Minwei Biopharma MWN109 Injection Starts Phase I Clinical Trial for Adult Weight Management [Google translation] (Sina Corp) - "Data from the Drug Clinical Trial Registration and Information Disclosure Platform show that Shanghai Minwei Biotechnology Co., Ltd. has initiated a randomized, double-blind, placebo-controlled Phase Ib clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple subcutaneous administration of MWN109 injection in Chinese non-diabetic overweight or obese participants. The clinical trial registration number is CTR20252486, and the first public information date is July 1, 2025...The primary endpoints of this trial include the incidence of adverse events (AEs)/serious adverse events (SAEs); changes in vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms....Currently, the experiment is in progress (not yet recruited), with a target enrollment of 40 people."

Trial status • Obesity

MWN109—A Novel Fatty Acid–Modified GLP-1/GIP/GCG Triagonist for Dual-Format Weight Management Demonstrates Superior Efficacy in Nonhuman Primates (ADA 2025) - "This study evaluates its weight loss efficacy, pharmacokinetics, and safety in NHP. In diet-induced obesity (DIO) monkey studies, SC MWN109 was compared with tirzepatide and retatrutide. MWN109 exhibits greater weight loss efficacy, favorable pharmacokinetics, and a promising safety profile, supporting its potential as a next-generation obesity treatment. The SC formulation has received IND clearance from both the NMPA and FDA and is currently in Phase 1 trials."

Clinical • Late-breaking abstract • Metabolic Disorders • Obesity • GCG

A phase 1 study to evaluate MWN109 injection in healthy subjects (ANZCTR) - P1 | N=72 | Recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2025

Enrollment open • Trial initiation date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate MWN109 Tablets in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P1 trial • Genetic Disorders • Obesity

A Study to Evaluate MWN109 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Obesity

A Study to Evaluate MWN109 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd

New P1 trial • Obesity

A phase 1 study to evaluate MWN109 injection in healthy subjects (ANZCTR) - P1 | N=72 | Not yet recruiting | Sponsor: Shanghai Minwei Biotechnology Co., Ltd.

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