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

Jiangsu Hansoh Pharmaceutical Co., Ltd.2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2023年10月16日最近更新: 2026年6月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 200
试验地点: 2
主要终点: Percent Change from Baseline in Body Weight

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female subjects,18-65 years of age at the time of signing informed consent.
•BMI≥28.0kg/m2 or 24≤BMI<28.0 kg/ m2 with at least 1 weight-related comorbidity at screening visit.
•Diet and exercise control for at least 3 months before screening visit,and less than 5 kg self-reported change within the last 3 months.

排除标准

•1. Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
•2. poor-controlled hypertension.
•PHQ-9 score≥
•Medical history or illness that affects your weight.
•Use of any medication or treatment that may have caused significant weight change within 3 months.
•6. History of bariatric surgery.
•History of diabetes.
•Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.
•9. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
•10. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix.
•11. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness.
•12. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening.
•13. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening.
•14. Known or suspected hypersensitivity to trial product(s)or related products.
•Female who is pregnant,breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
•16. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme,and their immediate family members.
•17. In the judgment of the investigator,there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.