IBI3046 in Overweight or Obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 trial evaluates safety, tolerability, and how the body handles IBI3046, including pharmacokinetics and pharmacodynamics, in Chinese adults with overweight or obesity. The study uses four parts: a single ascending dose, a multiple ascending dose, IBI3046 after stopping mazdutide, and a combination of IBI3046 with mazdutide. Participants are assigned to receive either IBI3046 or placebo under careful monitoring. The trial is conducted at Beijing Friendship Hospital and is sponsored by Innovent Biologics (Suzhou) Co. Ltd.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: baiyi yan
• Email: baiyi.yan@innoventbio.com
• Phone: 17710042669

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.