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RECRUITING
NCT07801820
PHASE2

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

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-06-23

Completion Date

2027-03

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

MWN109 1

Administered orally, QD, 20 weeks

DRUG

MWN109 2

Administered orally, QD, 20 weeks

DRUG

MWN109 3

Administered orally, QD, 20 weeks

DRUG

MWN109 4

Administered orally, QD, 20 weeks

DRUG

Placebo

Administered orally, QD, 20 weeks

DRUG

Semaglutide Tablets

Administered orally, QD, 20 weeks

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China