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

NCT07801820 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

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

Sponsors & Collaborators

  • Shanghai Minwei Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-23
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801820 on ClinicalTrials.gov