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COMPLETED
NCT07791654
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

MWN109 1

Administered SC, QW, 24 weeks

DRUG

MWN109 2

Administered SC, QW, 24 weeks

DRUG

MWN109 3

Administered SC, QW, 24 weeks

DRUG

Placebo

Administered SC, QW, 24 weeks

Locations (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China