A Study of HS-20094 in Chinese Adults with Overweight or Obesity

NCT ID: NCT06839664

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 610 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2026-02-27

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HS-20094 5mg

Group Type: EXPERIMENTAL

HS-20094 injection

Intervention Type: DRUG

Administered SC

HS-20094 10mg

Group Type: EXPERIMENTAL

HS-20094 injection

Intervention Type: DRUG

Administered SC

HS-20094 15mg

Group Type: EXPERIMENTAL

HS-20094 injection

Intervention Type: DRUG

Administered SC

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo injection

Intervention Type: DRUG

Administered SC

Interventions

HS-20094 injection

Administered SC

Intervention Type: DRUG

Placebo injection

Administered SC

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cuicui

Role: CONTACT

rmyyllwyh@163.com

010-88324516

Facility Contacts

Cuicui cong

Role: primary

rmyyllwyh@163.com

010-88324516

Other Identifiers

HS-20094-301

Identifier Type: -

Identifier Source: org_study_id