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A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a single dose of a medication called MK-0616. It aims to see how people with moderate kidney problems process this drug compared to healthy individuals. Researchers are studying how the drug is absorbed, distributed, and eliminated from the body.

Eligible Conditions
  • Chronic kidney disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent Clearance (CL/F) of MK-0616
Apparent Terminal Half-life (t1/2) of MK-0616
Apparent Volume of Distribution (Vz/F) of MK-0616
+4 more
Secondary study objectives
Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616
Fraction of Dose Recovered in Urine (Fe) of MK-0616
Number of Participants Who Discontinued From the Study Due to an AE
+3 more

Side effects data

From 2023 Phase 1 trial • 18 Patients • NCT05070390
13%
Palpitations
13%
Diarrhoea
13%
Fatigue
13%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panel A - Moderate Renal Impairment (RI)
Panel A - Moderate RI

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Panel B - Healthy ControlsExperimental Treatment1 Intervention
Single dose of enlicitide chloride 10 mg
Group II: Panel A - Moderate Renal Impairment (RI)Experimental Treatment1 Intervention
Single dose of enlicitide chloride 10 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enlicitide Chloride
2022
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,470 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,785 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,416 Total Patients Enrolled
~4 spots leftby Dec 2025
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