The goal of this study is to learn about the safety and tolerability of IBI3042, an investigational oral drug that activates the glucagon-like peptide-1 (GLP-1) receptor. The study will also assess how IBI3042 moves through the body and explore its effects on body weight and related measures. Researchers will evaluate whether single and multiple oral doses of IBI3042 can be administered with acceptable safety and tolerability. The study has two parts. In Part A, healthy or overweight participants will receive a single oral dose of IBI3042 or placebo. In Part B, overweight or obese participants will receive multiple oral doses of IBI3042 or placebo over 29 days. Participants will be assigned to different dose groups, and dose escalation will be guided by safety, tolerability, and available drug concentration data from earlier groups. Participants will undergo safety assessments and blood sampling during the study. These assessments will include medical examinations, vital signs, laboratory tests, and electrocardiograms. In Part B, researchers will also assess changes in body weight, body mass index, waist circumference, and other metabolic measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Hennan, China
Number of Participants With Adverse Events (Part A)
Time frame: Through study completion, an average of 29 days.
Number of Participants With Abnormal Physical Examination Findings (Part A)
Time frame: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Time frame: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Time frame: Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
Time frame: Through study completion, an average of 29 days.
Number of Participants With Adverse Events (Part B)
Time frame: Through study completion, an average of 57 days.
Number of Participants With Abnormal Physical Examination Findings (Part B)
Time frame: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Time frame: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Time frame: Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
Time frame: Through study completion, an average of 57 days.
Area under the blood concentration-time curve (AUC) (Part A)
Time frame: Through study completion, an average of 29 days.
Peak Plasma Concentration (Cmax) (Part A)
Time frame: Through study completion, an average of 29 days.
Time to Reach Peak Plasma Concentration (Tmax) (Part A)
Time frame: Through study completion, an average of 29 days.
Apparent Clearance (CL/F) (Part A)
Time frame: Through study completion, an average of 29 days.
Apparent Volume of Distribution (Vz/F) (Part A)
Time frame: Through study completion, an average of 29 days.
Terminal Half-Life (T1/2) (Part A)
Time frame: Through study completion, an average of 29 days.
Area Under the Plasma Concentration-Time Curve (AUC) (Part B)
Time frame: Through study completion, an average of 57 days.
Peak Plasma Concentration (Cmax) (Part B)
Time frame: Through study completion, an average of 57 days.
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Time frame: Through study completion, an average of 57 days.
Apparent Clearance (CL/F) (Part B)
Time frame: Through study completion, an average of 57 days.
Apparent Volume of Distribution (Vz/F) (Part B)
Time frame: Through study completion, an average of 57 days.
Terminal Half-Life (T1/2) (Part B)
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Time frame: Through study completion, an average of 57 days.
Changes in body weight from baseline (Part B)
Time frame: Through study completion, an average of 57 days.
Percentage change in body weight from baseline (Part B)
Time frame: Through study completion, an average of 57 days.
Percentage change in waist circumference from baseline (Part B)
Time frame: Through study completion, an average of 57 days.
Percentage change in body mass index (BMI) from baseline (Part B)
Time frame: Through study completion, an average of 57 days.
Body Mass Index (BMI) change from baseline (Part B)
Time frame: Through study completion, an average of 57 days.
Changes in waist circumference from baseline (Part B)
Time frame: Through study completion, an average of 57 days.