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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
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled phase II study conducted in China. It aims to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity. A total of 120 participants were enrolled in the study. All participants were randomly assigned using stratified block randomization by gender (male or female) and allocated to 4 treatment groups at a 1:1:1:1 ratio, with approximately 30 participants in each group. Each treatment group will reach the This study consists of a screening period of up to 2 weeks, a treatment period of 24 weeks, and a follow-up period of 2 weeks, totaling 28 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 24 weeks of drug administration. The secondary endpoints include the proportions of participants with a body weight reduction of ≥5%, ≥10%, ≥15%, and ≥20% relative to the baseline after 24 weeks of treatment, as well as the change in waist circumference relative to the baseline.target dose through dose titration.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-08-23
Completion Date
2026-03-21
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
MWN109 1
Administered SC, QW, 24 weeks
MWN109 2
Administered SC, QW, 24 weeks
MWN109 3
Administered SC, QW, 24 weeks
Placebo
Administered SC, QW, 24 weeks
Locations (1)
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China