Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus
Sponsor: Shanghai Minwei Biotechnology Co., Ltd • ClinicalTrials.gov ID: NCT07801820
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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.
Interventions
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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
Eligibility criteria
Conditions
Locations
- Peking University People's Hospital — Beijing, Beijing Municipality, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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