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A Study of IBI3046 in Participants With Overweight or Obesity

Not Yet RecruitingPhase 1

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Conditions: Obesity and Overweight

Interventions: IBI3046, placebo

Countries: China

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Beijing, Beijing Municipality, China