NCT06839664

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 610 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	HS-20094 injection	Administered SC
DRUG	Placebo injection	Administered SC

Timeline

• Start date: 2024-11-11
• Primary completion: 2026-01-27
• Completion: 2026-02-27
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: China