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

Phase 3

Recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: HS-20094 injection; Drug: Placebo injection

• Registration Number: NCT06839664
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2024-11-11
• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-01-27
• Study Completion: 2026-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 610

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HS-20094 5mg	HS-20094 injection	-
HS-20094 10mg	HS-20094 injection	-
HS-20094 15mg	HS-20094 injection	-
Placebo	Placebo injection	-

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, week 48	Percent Change from Baseline in Body Weight
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline	Baseline, week 48	Percentage of Participants Who Achieve weight loss≥ 5% from Baseline

Secondary Outcome Measures

Name	Time	Method
Change in waist circumference from baseline at week 48	Baseline, week 48	Change in waist circumference from baseline at week 48
Percentage change in body weight from baseline at week 24	Baseline, week 24	Percentage change in body weight from baseline at week 24
Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline	Baseline, week 4	Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China