NCT06118021

A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a study of HS-20094 in participants with overweight and obesity. The main purpose is to learn more about how HS-20094 affects body weight. The study period including 4-12 weeks dose titration and 12-20 weeks maintain treatment and 6 weeks follow up.

Detailed description

This is a phase 2, 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) from over 10 hospitals in China. Eligible participants were randomly assigned (4:1) within each cohort by using an interactive web-response system to receive once-weekly subcutaneous HS-20094 or placebo for 24 weeks in one of the 4 cohorts below：the 5 mg cohort (5 mg weeks 1-24) ，the 10 mg cohort（5 mg weeks 1-4，10 mg weeks 5-24），the 15 mg cohort（5 mg weeks 1-4，10 mg weeks 5-8,15 mg weeks 9-24），the 20 mg cohort（5 mg weeks 1-4，10 mg weeks 5-8，15 mg weeks 9-12，20 mg weeks 13-24）. The participants, investigators, study site personnel involved in treating and assessing participants in each cohort and sponsor personnel were masked to treatment allocation. The primary endpoints were the percent change in bodyweight from baseline and bodyweight reduction of 5% or higher. The secondary outcomes included the change from baseline to week 24 in waist circumference and BMI.

Conditions

• Overweight and Obesity

Interventions

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

Timeline

• Start date: 2023-10-16
• Primary completion: 2024-08-30
• Completion: 2024-10-16
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

2 sites across 1 country: China