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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
128
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Number of participants with Adverse Event
Time frame: 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)
Systolic blood pressure will be measured and recorded at each specified time point
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
diastolic blood pressure will be measured and recorded at each specified time point
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
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
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with clinically significant changes in physical examination results;
Time frame: 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
Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
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renal clearance (CLr)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Immunogenicity characteristics of IBI3046
To characterize the immunogenicity of IBI3046 based on serum sample analysis at prespecified time points as defined in the study protocol.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Area Under the Curve (AUC) of the serum concentration-time profile
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Maximum Concentration (Cmax) of the drug in serum
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
time to maximum concentration (Tmax)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Elimination Half-life (t1/2)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Amount of drug excreted in urine (Ae)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Fraction of dose excreted in urine(Fe)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD