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The purpose of this study is to assess how fast IBI362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 - Mild and Moderate Renal Impairment | Experimental | Group 2 - IBI362 administered SC to participants with mild and moderate renal impairment. |
|
| IBI362 - Healthy | Experimental | Group 1 - IBI362 administered subcutaneously (SC) to healthy participants with normal renal function. |
|
| IBI362 - Severe Renal Impairment | Experimental | Group 3 - IBI362 administered SC to participants with severe renal impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 | Drug | 2.0mg, SC, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362 | Predose through 1344 hours postdose | |
| PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362 | Predose through 1344 hours postdose |
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Inclusion Criteria:
All Participants:
o The weight of male subjects is not less than 50 kg, and the body weight of female subjects is not less than 45 kg, and the body mass index (BMI) is within the range of 20~30 kilograms per meter squared (kg/m²), inclusive, at screening
Healthy Participants:
-- Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening
Participants with Renal Impairment:
Exclusion Criteria:
All Participants:
Participants with Renal Impairment:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aerospace Center Hospital | Beijing | Beijing Municipality | 100049 | China |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |