This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic characteristics, efficacy, and safety of MWN105 Injection in non-diabetic participants with overweight or obesity. Approximately 120 participants will be randomized to receive different dose levels of MWN105 Injection or matching placebo, administered subcutaneously once weekly for a total treatment duration of 24 weeks, with dose titration from 15 mg to the target dose. The primary endpoint is the percent change from baseline in body weight at Week 24. Secondary endpoints include changes in body weight and metabolic parameters, bone mineral density, pharmacokinetic parameters, immunogenicity, and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Administered SC, QW, 24 weeks
Administered SC, QW, 24 weeks
Administered SC, QW, 24 weeks
Administered SC, QW, 24 weeks
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Percentage Change from Baseline in Body Weight at Week 24.
Time frame: Baseline, Week 24
Change from baseline in body weight over time
Change in body weight from baseline throughout the study.
Time frame: up to 24 weeks
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
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 24 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 24 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Change in HbA1c levels from baseline throughout the study.
Time frame: up to 24 weeks
Change from baseline in adiponectin over time
Change in adiponectin levels from baseline throughout the study.
Time frame: up to 24 weeks
Change from baseline in alanine aminotransferase (ALT) over time[
Change in ALT levels from baseline throughout the study.
Time frame: up to 24 weeks
Change from baseline in aspartate Aminotransferase (AST) over time
Change in ALT levels from baseline throughout the study.
Time frame: up to 24 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 24 weeks
Change from Baseline in Liver Fat Content (LFC) at Week 24
Change in LFC from baseline to Week 24.
Time frame: Baseline, Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with treatment-emergent adverse events throughout the study.
Time frame: up to 24 weeks
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