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

A Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: HS-20094 injection; Drug: Placebo injection

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 Type: Interventional
• Enrollment (Actual): 604
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female 18 to 65 years of age at the time of consent(cutoff value included).
• 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.
• Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo injection; Administered SC
Experimental: HS-20094 5mg	Drug: HS-20094 injection; Administered SC
Experimental: HS-20094 10mg	Drug: HS-20094 injection; Administered SC
Experimental: HS-20094 15mg	Drug: HS-20094 injection; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change from Baseline in Body Weight	Percent Change from Baseline in Body Weight	Baseline, week 48
Percentage of Participants Who Achieve weight loss≥ 5% from Baseline	Percentage of Participants Who Achieve weight loss≥ 5% from Baseline	Baseline, week 48

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2024
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HS-20094-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No