Clinical trial NCT06839664: A Study of HS-20094 in Chinese Adults with Overweight or Obesity
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1.Male or female 18 to 65 years of age at the time of consent(cutoff value included).

  2. Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea.

  3. Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.

Exclusion Criteria:

* 1. Diabetes mellitus 2. Weight change \>5.0% after diet and exercise control for at least 12 weeks before screening 3. Have used or are currently using weight loss drugs within 3 months before screening 4. History of pancreatitis 5. Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2) 6. History of moderate to severe depression, or have a history of serious mental illness 7. Any lifetime history of a suicide attempt 8. Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions 9. Have a history of any malignancy within the past 5 years

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, week 48
measure: Percentage of Participants Who Achieve weight loss≥ 5% from Baseline
timeFrame: Baseline, week 48
Secondary outcomes:
measure: Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline
timeFrame: Baseline, week 4
measure: Change in waist circumference from baseline at week 48
timeFrame: Baseline, week 48
measure: Percentage change in body weight from baseline at week 24
timeFrame: Baseline, week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: