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Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.
Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.
Not Yet RecruitingPhase 2
Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions: Overweight or Obesity
Interventions: SYH2069 Injection, SYH2069 Injection Placebo
Countries: China
To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.
Eligibility overview
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Locations (1)
- Nanjing, Jiangsu, China