Clinical Trials in China / NCT07809945
Recruiting
Phase 1
A Study of IBI3046 in Participants With Overweight or Obesity
NCT07809945 · tracked via the Priya Life Science China tracker
Condition(s) studied
Obesity and Overweight
Investigational drug(s) / intervention(s)
IBI3046placebo
IBI3046: subcutaneous injection
placebo: subcutaneous injection
Study summary
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
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.
Primary outcome measure(s)
- Number of participants with Adverse Event — up to Day 169 for SAD;up to Day 225 for MAD
- Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg) — up to Day 169 for SAD;up to Day 225 for MAD
Systolic blood pressure will be measured and recorded at each specified time point - Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg) — up to Day 169 for SAD;up to Day 225 for MAD
diastolic blood pressure will be measured and recorded at each specified time point - Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants) — up to Day 169 for SAD;up to Day 225 for MAD
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be - Number of participants with clinically significant changes in physical examination results； — up to Day 169 for SAD;up to Day 225 for MAD
- Number of participants with abnormal ECG changes before and after administration in each dose group — up to Day 169 for SAD;up to Day 225 for MAD
Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07809945 on ClinicalTrials.gov ↗ ← All trials in China