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
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
-
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
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