A Study of IBI3046 in Participants With Overweight or Obesity

A Randomized, Double Blind, Placebo Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of IBI3046 in Chinese Participants With Overweight or Obesity

This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide

Inclusion Criteria:

• 1.Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female;
• 2.At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²;
• 3.Body weight change ≤ 5 % within 3 months prior to screening ;
• 4.Female participants of child bearing potential and male participants whose partners are of child bearing potential must agree to use highly effective contraceptive methods during the study and for 6 months after the last study drug administration. For female participants of child bearing potential, the pregnancy test result must be negative at screening. Female participants shall not breast feed. Male / female participants must be willing to refrain from sperm / oocyte donation during the study and for 6 months after the last study drug administration;
• 5.Able to understand study procedures and requirements, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.

Exclusion Criteria:

• 1. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases.
• 2. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening.
• 3. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening.
• 4. Positive screening results for infectious pathogen markers.
• 5. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
• 6. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
• 7. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
• 8. History of malignant tumors (excluding partial skin cancers) within 5 years.
• 9. Positive screening results for infectious pathogen markers.
• 10. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
• 11. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
• 12. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
• 13. History of malignant tumors (excluding partial skin cancers) within 5 years.