RecruitingPhase 2NCT07801820

Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Placebo- and Active-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus


Sponsor

Shanghai Minwei Biotechnology Co., Ltd

Enrollment

240 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MWN109 1, a drug called MWN109 2, and others for people with type 2 diabetes mellitus (t2dm). 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

DRUGMWN109 1

Administered orally, QD, 20 weeks

DRUGMWN109 2

Administered orally, QD, 20 weeks

DRUGMWN109 3

Administered orally, QD, 20 weeks

DRUGMWN109 4

Administered orally, QD, 20 weeks

DRUGPlacebo

Administered orally, QD, 20 weeks

DRUGSemaglutide Tablets

Administered orally, QD, 20 weeks


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07801820


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