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

NCT07803809 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

  • Overweight , Obesity
  • Type 2 Diabetes Mellitus (T2DM)
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis

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

Sponsors & Collaborators

  • Shanghai Minwei Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-26
Primary Completion
2026-10-31
Completion
2027-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803809 on ClinicalTrials.gov