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

Last updated: February 18, 2025
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

HS-20094 injection

Placebo injection

Clinical Study ID

NCT06839664
HS-20094-301
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Male or female 18 to 65 years of age at the time of consent(cutoff valueincluded).
  1. Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 andprevious diagnosis with at least one of the following comorbidities:prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease,obstructive sleep apnea.

  2. Weight change ≤5.0% after diet and exercise control for at least 12 weeksbefore screening.

Exclusion

Exclusion Criteria:

  1. Diabetes mellitus 2. Weight change >5.0% after diet and exercise control for atleast 12 weeks before screening 3. Have used or are currently using weight lossdrugs within 3 months before screening 4. History of pancreatitis 5. Family orpersonal history of medullary thyroid carcinoma(MTC)or multiple endocrineneoplasia 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 asuicide attempt 8. Have a history of significant atopy (severe allergicmanifestations), multiple or severe drug allergies, or severe posttreatmenthypersensitivity reactions 9. Have a history of any malignancy within the past 5 years

Study Design

Total Participants: 610
Treatment Group(s): 2
Primary Treatment: HS-20094 injection
Phase: 3
Study Start date:
November 11, 2024
Estimated Completion Date:
February 27, 2026

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.