This study is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of MWN109 injection in Chinese non-diabetic participants with overweight or obesity. A total of 40 participants were enrolled in the study. All participants were stratified and randomized by gender in blocks, and randomly assigned to 4 dose groups at a ratio of 1:1:1:1, with 10 participants in each group(8 participants received MWN109 injection, and 2 received placebo). Each treatment group will use a dose titration method to reach the target dose. The study includes a maximum screening period of up to 2 weeks, a 14-week treatment period and a 2-week follow-up period, totaling 18 weeks. The primary endpoint is the incidence of adverse events. The secondary endpoint is the pharmacokinetic characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Administered SC, QW, 14 weeks
Administered SC, QW, 14 weeks
Administered SC, QW, 14 weeks
Administered SC, QW, 14 weeks
Administered SC, QW, 14 weeks
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, China
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability assessed by the incidence of AEs and SAEs.
Time frame: From Day 1 to Day 113
Maximum Concentration (Cmax)
Cmax of MWN109.
Time frame: From Day 1 to Day 60
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN109.
Time frame: From Day 1 to Day 60
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN109.
Time frame: From Day 1 to Day 60
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN109.
Time frame: From Day 1 to Day 60
Elimination Half-Life (t1/2)
t1/2 of MWN109.
Time frame: From Day 1 to Day 60
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN109.
Time frame: From Day 1 to Day 113
Steady State Minimum Concentration (Cmin,ss)
Cmin,ss of MWN109.
Time frame: From Day 1 to Day 113
Steady State Concentration (Cav,ss)
Cav,ss of MWN109.
Time frame: From Day 1 to Day 113
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN109.
Time frame: From Day 1 to Day 113
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN109.
Time frame: From Day 1 to Day 113
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
AUC0-τ,ss of MWN109.
Time frame: From Day 1 to Day 113
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
AUC0-t,ss of MWN109.
Time frame: From Day 1 to Day 113
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