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COMPLETED
NCT07787728
PHASE1

Phase Ib Clinical Study of MWN109 Injection in Participants With Overweight or Obesity

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Subcutaneous Administrations of MWN109 Injection in Chinese Non-Diabetic Participants With Overweight or Obesity

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07-14

Completion Date

2025-12-16

Last Updated

2026-08-26

Healthy Volunteers

No

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

Placebo

Administered SC, QW, 14 weeks

Locations (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, China