Obesity and Overweight
Conditions
Brief 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
Interventions
DRUGIBI3046
subcutaneous injection
DRUGplacebo
subcutaneous injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to maximum concentration (Tmax) | up to Day 3 for SAD;up to Day 57 for MAD | — |
| Elimination Half-life (t1/2) | up to Day 3 for SAD;up to Day 57 for MAD | — |
| Fraction of dose excreted in urine(Fe) | up to Day 3 for SAD;up to Day 57 for MAD | — |
| Amount of drug excreted in urine (Ae) | up to Day 3 for SAD;up to Day 57 for MAD | — |
| renal clearance (CLr) | up to Day 3 for SAD;up to Day 57 for MAD | — |
| Immunogenicity characteristics of IBI3046 | up to Day 169 for SAD;up to Day 225 for MAD | To characterize the immunogenicity of IBI3046 based on serum sample analysis at prespecified time points as defined in the study protocol. |
| Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight. | up to Day 169 for SAD;up to Day 225 for MAD | — |
| Area Under the Curve (AUC) of the serum concentration-time profile | up to Day 3 for SAD;up to Day 57 for MAD | — |
| Maximum Concentration (Cmax) of the drug in serum | up to Day 3 for SAD;up to Day 57 for MAD | — |
Countries
China
Contacts
CONTACTbaiyi yan
Outcome results
None listed