The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks.
This is a phase Ⅲ, double-blind, randomised, placebo-controlled trial to assess the efficacy of HS-20094 in Chinese subjects with overweight or obesity. We enrolled adults (aged 18-65 years, both inclusive) with overweight (body-mass index \[BMI\] ≥24 kg/m2) accompanied by at least one obesity-related comorbidity or obesity (BMI ≥28 kg/m2) in China. Eligible participants were randomly assigned to receive once-weekly subcutaneous HS-20094 or placebo for 48 weeks. The co-primary endpoints were the percent change in bodyweight from baseline and the proportion of patients achieving weight loss≥5% from baseline after 48 weeks treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
610
Administered SC
Administered SC
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercent Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight
Time frame: Baseline, week 48
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline
Time frame: Baseline, week 48
Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline
Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline
Time frame: Baseline, week 4
Change in waist circumference from baseline at week 48
Change in waist circumference from baseline at week 48
Time frame: Baseline, week 48
Percentage change in body weight from baseline at week 24
Percentage change in body weight from baseline at week 24
Time frame: Baseline, week 24
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