A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Efsubaglutide Alfa Injection in Subjects With Overweight or Obesity
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI \< 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent form (ICF);
• Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing the ICF;
• Obese: BMI ≥ 30.0 kg/m2, with or without comorbidities; Or overweight: 27.0 kg/m2 ≤ BMI \< 30.0 kg/m2, with at least one of the following weight-related comorbidities: pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or obesity-induced obstructive sleep apnea syndrome (If the subject has only fatty liver as a comorbidity, imaging results within the 3 months prior to screening are required for fatty liver);
• A self-reported change in body weight less than 5.0% controlled with diet and exercise within 3 months before screening;
• Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception methods throughout the study (from the signing of ICF to 3 months after the last dose of investigational medicinal products).
The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, reaching the target dose of 20 mg, the total treatment last for 22weeks.
Experimental: Efsubaglutide 40 mg QW
The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg, reaching the target dose of 40 mg, the total treatment last for 22weeks.
Experimental: Efsubaglutide Alfa 40 mg Q2W
The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg,when reaching to target dose of 40 mg, administered the drug every 2weeks. the total treatment last for 22weeks.
Experimental: Efsubaglutide Alfa 80 mg QW
The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg, reaching the target dose of 80 mg, the total treatment last for 22weeks.
Experimental: Efsubaglutide Alfa 80 mg Q4W
The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg,when reaching to target dose of 80 mg, administered the drug every 4weeks. the total treatment last for 22weeks.