This is a phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial to preliminarily evaluate the efficacy, safety, and PK of MWN109 tablets administered orally once daily in non-diabetic participants with overweight or obesity. Approximately 240 participants will be enrolled. All participants will be stratified by gender (male or female) and then randomized 1:1:1:1:1 to 5 treatment groups, with approximately 48 participants per group. All treatment groups will implement dose titration to achieve the target dose. This study consists of a screening period of up to 2 weeks, a treatment period of 20 weeks, and a follow-up period of 2 weeks, totaling 24 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 20 weeks of drug administration. The secondary endpoints include the proportions of participants with a body weight reduction of ≥5%, ≥10%, ≥15%, and ≥20% relative to the baseline after 20 weeks of treatment, as well as the change in waist circumference relative to the baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
255
Administered orally, QD, 20 weeks
Administered orally, QD, 20 weeks
Administered orally, QD, 20 weeks
Administered orally, QD, 20 weeks
Administered orally, QD, 20 weeks
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Percentage change in body weight compared to baseline after 20 weeks of drug administration
Percentage change in body weight from baseline to Week 20.
Time frame: Baseline, week 20
Change from baseline in body weight over time
Change in body weight from baseline to week 20.
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 5% or more from baseline at week 20.
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 10% or more from baseline at week 20.
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 15% or more from baseline at week 20.
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 20% or more from baseline at week 20.
Time frame: Baseline, week 20
Change from baseline in waist circumference over time
Change in waist circumference from baseline to week 20.
Time frame: up to 20 weeks
Change from baseline in body mass index (BMI) over time
Change in BMI from baseline throughout the study.
Time frame: up to 20 weeks
Change from baseline in lipid profile over time
Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline throughout the study.
Time frame: up to 20 weeks
Change from baseline in blood pressure over time
Change in systolic and diastolic blood pressure from baseline throughout the study.
Time frame: up to 20 weeks
Change from baseline in fasting insulin over time
Change in fasting serum insulin levels from baseline throughout the study.
Time frame: up to 20 weeks
Change from baseline in fasting plasma glucose (FPG) over time
Change in fasting plasma glucose levels from baseline throughout the study.
Time frame: up to 20 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Change in HbA1c levels from baseline throughout the study.
Time frame: up to 20 weeks
Change from baseline in serum uric acid over time
Change in serum uric acid levels from baseline throughout the study.
Time frame: up to 20 weeks
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score over time
Change in IWQOL-Lite-CT score from baseline throughout the study. The IWQOL-Lite-CT, a 20-item patient-reported outcome (PRO) tool, evaluates weight-related physical and psychosocial function. Each of its 5 response choices (A-E) yields a score from 1 to 5. Total scores range from 20 to 100. Higher composite and total scores are associated with better participant-reported functioning.
Time frame: up to 20 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with treatment-emergent adverse events throughout the study.
Time frame: up to 20 weeks]
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