At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
Enlicitide Decanoatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-0616 in Participants With Varying Degrees of Renal Impairment
In Brief
A Phase 1 clinical trial evaluating Enlicitide Decanoate for Hypercholesterolaemia. Completed, enrolled 33 participants across 5 sites.
Detailed Summary
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease \[ESRD\]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolaemia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedJul 2023
Enrollment StartJul 2023
Primary CompletionJan 2024
TodayJul 2026
First PostedJul 6, 2023
Enrollment StartJul 20, 2023
Primary CompletionJan 19, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.0 years ago
Interventions
Enlicitide Decanoatedrug
Oral dose