NCT07809945RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Obesity
- NCT number
- NCT07809945
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 128
- From Sept 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1\. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases.
- 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.
- 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.
Lab values
- 2\. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening.
Other
- 3\. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening.
- 4\. Positive screening results for infectious pathogen markers.
- 9\. Positive screening results for infectious pathogen markers.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.