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This is a randomized, double-blind, placebo-controlled phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of IBI3032 in participants with overweight or obesity. It is a multiple ascending dose study in participants with overweight or obesity during the 4-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple ascending dose5 of IBI3032 administered orally. | Experimental | Cohort 5 IBI3032 |
|
| Multiple ascending dose1 of placebo administered orally. | Placebo Comparator | Cohort 1 placebo |
|
| Multiple ascending dose4 of placebo administered orally. | Placebo Comparator | Cohort 4 placebo |
|
| Multiple ascending dose3 of IBI3032 administered orally. | Experimental | Cohort 3 IBI3032 |
|
| Multiple ascending dose4 of IBI3032 administered orally. | Experimental | Cohort 4 IBI3032 |
|
| Multiple ascending dose2 of IBI3032 administered orally. | Experimental | Cohort 2 IBI3032 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3032 | Drug | IBI3032. Method of administration: oral, fasted administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Day 43 |
| Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Day 43 |
| Number of Participants with adverse events (AEs) | Baseline up to Day 43 | An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. |
| Measure | Description | Time Frame |
|---|---|---|
| Under the Serum Concentration-time Curve (AUC) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose. |
| maximum concentration (Cmax) of IBI3032 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Frist Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Multiple ascending dose3 of placebo administered orally. | Placebo Comparator | Cohort 3 placebo |
|
| Multiple ascending dose5 of placebo administered orally. | Placebo Comparator | Cohort 5 placebo |
|
| Multiple ascending dose1 of IBI3032 administered orally. | Experimental | Cohort 1 IBI3032 |
|
| Multiple ascending dose2 of placebo administered orally. | Placebo Comparator | Cohort 2 placebo |
|
| placebo | Drug | Placebo (without active ingredients). Method of administration: oral, fasted administration. |
|
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose. |
| time to maximum concentration (Tmax) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose. |
| clearance (CL) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose. |
| apparent volume of distribution (V) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose. |
| elimination half-life (T1/2) of IBI3032 | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. | Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |