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.
Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form.
Diagnosis of type 2 diabetes mellitus for at least 3 months prior to screening, with inadequate glycemic control despite treatment with lifestyle intervention or a stable dose of metformin monotherapy (≥1500 mg/day, or ≥1000 mg/day if at the maximum tolerated dose) for at least 3 months prior to screening.
HbA1c ≥7.5% and ≤11.0% at screening and before randomization (central laboratory).
Fasting plasma glucose ≤13.9 mmol/L at screening and before randomization (central laboratory; may be re-tested once within 1 week if special circumstances apply).
Known allergic constitution (allergy to 3 or more foods or drugs), allergy to GLP-1 receptor agonists or any component of the study drug, severe allergic disease, or a history of severe drug allergy.
Diagnosed or suspected type 1 diabetes mellitus, other specific types of diabetes mellitus (excluding gestational diabetes mellitus), or secondary diabetes mellitus.
Severe chronic complications of diabetes mellitus (e.g., diabetic nephropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy requiring treatment, peripheral vascular disease with amputation, chronic foot ulcer, intermittent claudication, or painful diabetic neuropathy).
Use of insulin within 1 year prior to randomization (except for acute short-term use of ≤14 days).
Parallel
MWN109 1
DrugAdministered orally, QD, 20 weeks
MWN109 2
DrugAdministered orally, QD, 20 weeks
MWN109 3
DrugAdministered orally, QD, 20 weeks
MWN109 4
DrugAdministered orally, QD, 20 weeks
Placebo
DrugAdministered orally, QD, 20 weeks
Semaglutide Tablets
DrugAdministered orally, QD, 20 weeks
6
Treatment groupsSee each treatment group below.
Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 20 Compared to Placebo
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify the average plasma glucose concentration over prolonged periods.
Change in HbA1c from Baseline at Week 20 Compared with Semaglutide Tablets
Change from baseline in HbA1c
Percentage of Participants With an HbA1c target value of < 7.0%
Percentage of Participants With an HbA1c target value of ≤ 6.5%
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