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.
