Clinical trial
Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.
Opening soon · Phase 2 · 1 countries · Registry ID NCT07803991
Opening soonPhase 2Interventional
What this study is about
To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight or Obesity
Full registry 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.
Treatments and study arms
SYH2069 Injection
Drug
0.6ml , 1.2ml , administered subcutaneously (SC),Administer the drug according to the clinical trial protocol
SYH2069 Injection Placebo
Drug
0.6ml , 1.2ml , SC,Administer the drug according to the clinical trial protocol
Primary outcomes
Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment28 weeks
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School🇨🇳 Nanjing, Jiangsu, China
Yan BiContact