RecruitingPhase 1NCT07803809

Phase 1 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity

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


Sponsor

Shanghai Minwei Biotechnology Co., Ltd

Enrollment

36 participants

Start Date

Apr 26, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MWN105 1, a drug called MWN105 2, and others for people with mash - metabolic dysfunction-associated steatohepatitis, overweight/obesity, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMWN105 1

Administered SC, QW, 8 weeks

DRUGMWN105 2

Administered SC, QW, 8 weeks

DRUGMWN105 3

Administered SC, QW, 8 weeks

DRUGPlacebo

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

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NCT07803809


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