Phase Ib Clinical Study of MWN109 Injection in Participants With Overweight or Obesity
NCT07787728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-08-28
Summary
This study is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of MWN109 injection in Chinese non-diabetic participants with overweight or obesity.
A total of 40 participants were enrolled in the study. All participants were stratified and randomized by gender in blocks, and randomly assigned to 4 dose groups at a ratio of 1:1:1:1, with 10 participants in each group(8 participants received MWN109 injection, and 2 received placebo). Each treatment group will use a dose titration method to reach the target dose.
The study includes a maximum screening period of up to 2 weeks, a 14-week treatment period and a 2-week follow-up period, totaling 18 weeks. The primary endpoint is the incidence of adverse events. The secondary endpoint is the pharmacokinetic characteristics.
Conditions
- Overweight , Obesity
Interventions
- DRUG
-
MWN109 1
Administered SC, QW, 14 weeks
- DRUG
-
MWN109 2
Administered SC, QW, 14 weeks
- DRUG
-
MWN109 3
Administered SC, QW, 14 weeks
- DRUG
-
MWN109 4
Administered SC, QW, 14 weeks
- DRUG
-
Administered SC, QW, 14 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
- 2025-07-14
- Primary Completion
- 2025-12-16
- Completion
- 2025-12-16
Countries
- China
Study Locations
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