This clinical research study is testing the study compound petrelintide that is being developed for the weight management in people with obesity or overweight with comorbidities or related diseases. The aim of this clinical research study is to investigate whether the effects of petrelintide will be different in people with normal kidney function compared to people with impaired kidney function.
This is a Phase 1, open-label, single-center, single dose, parallel-group, non-randomized study to evaluate the pharmacokinetics (PK), safety, and tolerability of petrelintide after a single dose in participants with mild, moderate, or severe renal impairment, and participants with normal renal function. Allocation of participants to the renal function groups will be based on the estimated glomerular filtration rate (eGFR). Each participant will receive a single subcutaneous dose of petrelintide on Day 1. Up to 24 participants with normal renal function and 24 participants with renal impairment (8 participants each in the following groups: mild, moderate, or severe renal impairment) will participate in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Solution administered with a syringe
Charité Research Organisation GmbH
Berlin, Germany
AUCo-inf of petrelintide
AUCo-inf: Area Under the Curve from time 0 to infinity
Time frame: From administration (Day 1) to Last visit (Day 43)
Maximum observed plasma concentration
Time frame: From administration (Day 1) to Last visit (Day 43)
Time to attain maximum observed plasma concentration
Time frame: From administration (Day 1) to Last visit (Day 43)
Area under the plasma concentration-time curve from time 0 to infinity
Time frame: From administration (Day 1) to Last visit (Day 43)
Area under the concentration versus time curve from time zero to last measurable concentration
Time frame: From administration (Day 1) to Last visit (Day 43)
Terminal elimination half-life
Time frame: From administration (Day 1) to Last visit (Day 43)
Apparent clearance
Time frame: From administration (Day 1) to Last visit (Day 43)
Apparent volume of distribution at terminal phase
Time frame: From administration (Day 1) to Last visit (Day 43)
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