Phase 2 Study of MWN109 Tablet in Participants With Overweight or Obesity

NCT07791524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2026-08-28

No results posted yet for this study

Summary

This is a phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial to preliminarily evaluate the efficacy, safety, and PK of MWN109 tablets administered orally once daily in non-diabetic participants with overweight or obesity.

Approximately 240 participants will be enrolled. All participants will be stratified by gender (male or female) and then randomized 1:1:1:1:1 to 5 treatment groups, with approximately 48 participants per group. All treatment groups will implement dose titration to achieve the target dose.

This study consists of a screening period of up to 2 weeks, a treatment period of 20 weeks, and a follow-up period of 2 weeks, totaling 24 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 20 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 20 weeks of treatment, as well as the change in waist circumference relative to the baseline.

Conditions

  • Overweight , Obesity

Interventions

DRUG

MWN109 1

Administered orally, QD, 20 weeks

DRUG

MWN109 2

Administered orally, QD, 20 weeks

DRUG

MWN109 3

Administered orally, QD, 20 weeks

DRUG

MWN109 4

Administered orally, QD, 20 weeks

DRUG

Placebo

Administered orally, QD, 20 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
2026-01-05
Primary Completion
2026-07-09
Completion
2026-07-09

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 NCT07791524 on ClinicalTrials.gov