Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus
NCT07801820 · Recruiting
Last updated 2026-09-22This clinical trial is testing the effects of MWN109 tablets on people with type 2 diabetes to see how it changes their blood sugar levels over 20 weeks compared to a placebo.
What this study is testing ClinicalTrials.gov NCT07801820 ↗
Description as written by the study sponsor.
This is a randomized, double-blind, placebo- and active-controlled, multicenter Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of MWN109 tablets in participants with type 2 diabetes mellitus (T2DM). Eligible participants will be randomized to receive different dose levels of MWN109 tablets, MWN109-matched placebo, or semaglutide tablets 14 mg (active control), administered once daily for 20 consecutive weeks. Approximately 240 adults aged 18 to 75 years with type 2 diabetes mellitus will be enrolled. The primary endpoint is the percent change from baseline in HbA1c at Week 20. Secondary endpoints include glycemic parameters, body weight, metabolic parameters, adverse events, and immunogenicity.
Treatments tested
- MWN109 1 Drug
Administered orally, QD, 20 weeks
- MWN109 2 Drug
Administered orally, QD, 20 weeks
- MWN109 3 Drug
Administered orally, QD, 20 weeks
- MWN109 4 Drug
Administered orally, QD, 20 weeks
- Placebo Drug
Administered orally, QD, 20 weeks
- Semaglutide Tablets Drug
Administered orally, QD, 20 weeks
| Main thing measured | Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 20 Compared to Placebo |
|---|---|
| Sponsor | Shanghai Minwei Biotechnology Co., Ltd |
| Conditions studied | Type 2 Diabetes Mellitus (T2DM) |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07801820 ↗