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
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).
• BMI ≥20.0 kg/m² and ≤40.0 kg/m² at screening.
• Self-reported body weight change of \<5% during the at least 12 weeks prior to screening.