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Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity

NCT07778693 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2026-08-21

No results posted yet for this study

Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity.

Approximately 760 participants will be enrolled. All participants will be stratified by gender (male or female) and baseline BMI level, and then randomized 1:1:1:1 to 4 treatment groups, with 190 participants per group. All treatment groups will implement dose titration to achieve the target dose.

The study comprises a screening period of up to 2 weeks, a 52-week treatment period, and a 4-week follow-up period, for a total study duration of 58 weeks. The primary endpoints are the percentage change in body weight from baseline and the proportion of participants achieving ≥5% weight reduction from baseline at Week 52. The secondary endpoints include the proportions of participants achieving ≥10% and ≥15% weight reduction from baseline, as well as the change from baseline in waist circumference at Week 52.

Conditions

  • Overweight , Obesity

Interventions

DRUG

MWN109 1

Administered SC, QW, 52 weeks

DRUG

MWN109 2

Administered SC, QW, 52 weeks

DRUG

MWN109 3

Administered SC, QW, 52 weeks

DRUG

Placebo

Administered SC, QW, 52 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
2026-09-01
Primary Completion
2027-09-30
Completion
2027-11-30

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 NCT07778693 on ClinicalTrials.gov