This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 injection in Chinese non-diabetic overweight or obese participants.
The study plans to enroll 36 male and female participants. Three dose groups were preset, with 12 participants in each. They were randomly assigned to receive MWN105 injection or placebo at a ratio of 5:1 and were administered the treatment in a titration manner, once a week, with a dose increase every two weeks until reaching the target dose. The administration lasted for 8 weeks.
The study consists of a 2-week screening period, an 8-week administration/observation period, and a 4-week follow-up period, totaling 14 weeks. The primary endpoint is the incidence of adverse events. Secondary endpoints include pharmacokinetics, pharmacodynamics, and immunogenicity.
Participants should be aged 18 to 50 years (inclusive, based on the date of signing the informed consent form) and be male or female, non-diabetic, overweight or obese individuals from China.
Obese individuals: BMI ≥ 28.0 kg/m²; overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m², with or without the following: i. Complications including prediabetes (impaired fasting glucose and/or impaired glucose tolerance), hypertension, metabolic dysfunction-associated steatotic liver disease, or dyslipidemia; ii. Weight-bearing joint pain; iii. Breathing difficulties caused by obesity or obstructive sleep apnea syndrome.
Female participants must have no plans for pregnancy or egg donation from 14 days before the first administration until 4 months after the last administration, and must voluntarily use effective contraception. Male participants must have no plans for sperm donation from the first administration until 4 months after the last administration and must voluntarily use effective contraception to prevent partner pregnancy.
Individuals with a history of severe drug allergy, concurrent severe allergic diseases, or a severe allergic constitution.
Secondary or drug-induced obesity.
Type 1 or type 2 diabetes.
Acute or chronic pancreatitis or pancreatic injury.
Sequential
MWN105 1
DrugAdministered SC, QW, 8 weeks
MWN105 2
DrugAdministered SC, QW, 8 weeks
MWN105 3
DrugAdministered SC, QW, 8 weeks
Placebo
DrugAdministered SC, QW, 8 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability assessed by the incidence of AEs and SAEs.
Maximum Concentration (Cmax)
Cmax of MWN105.
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN105.
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN105.
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN105.
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