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Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight

NCT07791537 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-08-28

No results posted yet for this study

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 overweight or obese participants.

A total of 125 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 target dose through dose titration.

This study consists of a screening period of up to 2 weeks, a treatment period of 36 weeks, and a follow-up period of 4 weeks, totaling 42 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 36 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 36 weeks of treatment, as well as the change in waist circumference relative to the baseline.

Conditions

  • Overweight , Obesity

Interventions

DRUG

MWN109 1

Administered SC, QW, 36 weeks

DRUG

MWN109 2

Administered SC, QW, 36 weeks

DRUG

MWN109 3

Administered SC, QW, 36 weeks

DRUG

Placebo

Administered SC, QW, 36 weeks

Sponsors & Collaborators

  • Shanghai Minwei Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-26
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791537 on ClinicalTrials.gov