Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.

Korábbi kezelés

• 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.
• 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;
• 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.

Más betegség

• 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;
• 6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
• 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).
• 17. Any other conditions that, in the investigator's judgment, render the participant unsuitable for this study.

Laborértékek

• 11. Clinically significant hematological diseases, hemolytic or red blood cell disorders, or baseline conditions that interfere with HbA1c measurement at screening or randomization.

Egyéb

• 12. Participants with inadequately controlled blood pressure
• 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.

• 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).