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RECRUITING
NCT07803809
PHASE1

Phase 1 Clinical Study of MWN105 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, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 injection in Chinese non-diabetic overweight or obese participants. The study plans to enroll 36 male and female participants. Three dose groups were preset, with 12 participants in each. They were randomly assigned to receive MWN105 injection or placebo at a ratio of 5:1 and were administered the treatment in a titration manner, once a week, with a dose increase every two weeks until reaching the target dose. The administration lasted for 8 weeks. The study consists of a 2-week screening period, an 8-week administration/observation period, and a 4-week follow-up period, totaling 14 weeks. The primary endpoint is the incidence of adverse events. Secondary endpoints include pharmacokinetics, pharmacodynamics, and immunogenicity.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Administrations of MWN105 Injection in Chinese Non-Diabetic Participants With Overweight or Obesity

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-04-26

Completion Date

2027-01

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

MWN105 1

Administered SC, QW, 8 weeks

DRUG

MWN105 2

Administered SC, QW, 8 weeks

DRUG

MWN105 3

Administered SC, QW, 8 weeks

DRUG

Placebo

Administered SC, QW, 8 weeks

Locations (1)

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

Kunming, Yunnan, China