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TrialNCT07803809

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

Status
RECRUITING
Phase
PHASE1
Last update posted
09/04/2026
Start
04/26/2026
Sponsor
Shanghai Minwei Biotechnology Co., Ltd
Specialties
diabetes, family-medicine

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

Brief 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.

Protocol documents and results are not hosted here. Verify every detail on ClinicalTrials.gov.

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