A Multicenter, Randomized, Double-blind, Placebo Parallel-Controlled, Phase II Study to Evaluate the Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes

CSPC Ouyi Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 360 人开始时间: 2026年9月1日最近更新: 2026年9月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方: CSPC Ouyi Pharmaceutical Co., Ltd.
入组人数: 360
试验地点: 1
主要终点: Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment

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

To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.

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: Triple (Participant, Care Provider, 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: 否

入选标准

•1.Male or female participants, 18-65 years of age at the time of signing informed consent;
•2.At screening visit, 28.0 kg/m^2≤BMI≤ 40.0 kg/m^2;
•3.Maintained consistent diet and exercise habits with stable body weight within the 12 weeks prior to screening (self-reported weight variation <5%).;
•4.Able to understand and comply with trial procedures, voluntarily participate in the trial, and provide written informed consent (ICF).

排除标准

•1. Participants with a history of diabetes mellitus or hypoglycemic episodes;
•2. Participants with obesity caused by known single-gene mutations, other medical conditions, or medications, or weight gain not resulting from increased adipose tissue mass;
•3. Use of any medications or products that alter body weight and interfere with weight assessment within 3 months prior to screening;
•4. Prior bariatric surgery or weight-loss interventions, or plan to receive any bariatric surgery or weight-loss intervention during the trial.
•5. History of or known hypersensitivity to any active ingredient or excipient of the investigational product; known allergic diathesis; or severe allergic diseases present at screening.
•6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
•7. Prior history of acute or chronic pancreatitis or pancreatic injury; history of acute gallbladder disease within 1 year prior to screening; .
•8. History of severe cardiovascular or cerebrovascular events within 6 months prior to screening.
•9. Prior severe respiratory, central nervous system or psychiatric disorders; any suicide attempts within the past 2 years, or suicidal ideation within 3 months prior to screening or during screening;
•10. Any treated or untreated malignancy diagnosed from 5 years before screening through randomization (clinically cured basal cell carcinoma or carcinoma in situ are exempted).
•11. Clinically significant hematological diseases, hemolytic or red blood cell disorders, or baseline conditions that interfere with HbA1c measurement at screening or randomization.
•12. Participants with inadequately controlled blood pressure
•13. History of alcohol abuse, substance misuse or illicit drug use prior to screening
•14. Severe trauma, severe or acute infection occurring within 3 months prior to screening or between screening and randomization
•15. Prior clinical trial exposure to study drug within 90 days pre-screening or 5 drug half-lives, whichever is longer.
•16. Pregnancy or lactation; fertile male or female participants and their partners who fail to use effective contraception throughout the trial and for 3 months following the end of treatment.
•17. Any other conditions that, in the investigator's judgment, render the participant unsuitable for this study.

研究组 & 干预措施