Moderate Renal ImpairmentPhase 1NCT05070390

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

A Phase 1 study testing Enlicitide Chloride in people with Moderate Renal Impairment, run by Merck Sharp & Dohme LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Moderate Renal Impairment
What is being tested?: Enlicitide Chloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 2 sitesUnited States
Study dates: 16 Nov 2021to 3 May 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Good health based upon medical history, physical examination, vital signs, laboratory safety tests, and electrocardiograms (ECG) performed before randomization
Body mass index (BMI) ≥18 kg/m^2 and ≤40 kg/m^2
Male participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm, PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent, or use acceptable contraception per study protocol
Female participants must be of non-childbearing potential
Moderate RI participants: Baseline estimated glomerular filtration rate (eGFR) ≥30 and <60 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) equation
Moderate Renal Impairment (RI) participants: No clinically significant change in renal status at least 1 month prior to dosing and not currently receiving or has not previously been on hemodialysis
Healthy Matched Controls: eGFR ≥80 mL/min/1.73 m^2 based on the MDRD equation

Who cannot join

Healthy Matched Controls: history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator
History of cancer, with the exception of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study
History of significant multiple and/or severe allergies
Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit

Show all 12Show fewer

Moderate RI participants: Does not agree to follow the smoking restrictions as defined by the study
Healthy Matched Controls: History of smoking and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening
Received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention with the exception of Corona virus disease (COVID-19) vaccine administration. Study intervention must be given at least 72 hours following or at least 48 hours prior to any COVID-19 vaccination
Consumes greater than 3 servings of alcoholic beverages per day
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
Regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Velocity Clinical Research, Hallandale Beach ( Site 0002)
Hallandale, Florida, 33009
Alliance for Multispecialty Research, LLC ( Site 0001)
Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: An Open-Label Clinical Study to Evaluate the Pharmacokinetics of MK-0616 Following Administration of a Single Dose to Participants With Moderate Renal Impairment

This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants. Moderate RI was defined as the estimated glomerular filtration rate (eGFR) ≥30 and <60milliliter/minute/1.73meters^2 (ml/min/1.73m^2). There is no formal hypothesis.

Conditions: Moderate Renal Impairment
Being tested: Enlicitide Chloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enlicitide ChlorideDrug
Also called MK-0616
10 mg capsule administered orally

Study groups in NCT05070390
Study group	Role	What they receive
Panel A - Moderate Renal Impairment (RI)	Experimental	Single dose of enlicitide chloride 10 mg Receives: Drug: Enlicitide Chloride
Panel B - Healthy Controls	Experimental	Single dose of enlicitide chloride 10 mg Receives: Drug: Enlicitide Chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-0616. AUC0-inf was defined as the area under the concentration-time curve of MK-0616 from time zero to infinity.
Measured: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616.
Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration.
Measured: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Maximum Plasma Concentration (Cmax) of MK-0616
Blood samples were collected at pre-specified time points to determine the Cmax of MK-0616. Cmax was defined as the maximum concentration of MK-0616 reached.
Measured: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Time to Maximum Plasma Concentration (Tmax) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the Tmax of MK-0616. Tmax was defined as time to the maximum concentration of MK-0616 reached.
Measured: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Apparent Terminal Half-life (t1/2) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the t1/2 of MK-0616. t1/2 was defined as the time required to divide the MK-0616 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-0616.
Measured: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Apparent Clearance (CL/F) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma.
Measured: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Apparent Volume of Distribution (Vz/F) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration.
Measured: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose

Secondary outcomes (6)

Number of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.
Measured: Up to approximately 14 days
Number of Participants Who Discontinued From the Study Due to an AE
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who discontinued from the study due to an AE were reported.
Measured: Up to approximately 14 days
Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616
Urine samples were collected at pre-specified time points to determine the AE0-24 of MK-0616. Ae0-24 was defined as the amount of MK-0616 recovered in urine from time 0-24 hours.
Measured: Predose and at 0, 4, 8, 12 and 24 hours postdose
Fraction of Dose Recovered in Urine (Fe) of MK-0616
Urine samples were collected at pre-specified time points to determine the Fe of MK-0616. Fe was defined as the fraction of dose of MK-0616 recovered in urine.
Measured: Predose and at 0, 4, 8, 12, 24, 36 and 48 hours postdose
Renal Clearance (CLr) of MK-0616
Urine samples were collected at pre-specified time points to determine the CLr of MK-0616. was defined as the time it takes for the MK-0616 to be completely removed by the kidneys.
Measured: Predose and 4, 8, 12, 24, 36, and 48 hours postdose
Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9)
Urine samples were collected at pre-specified time points (baseline and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 and 336 hours postdose) to evaluate the reduction in free PCSK9 from baseline to up to 336 hours postdose after administration of MK-0616. The percent change from baseline in free PCSK9 was reported.
Measured: Baseline (Predose) and up to 336 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 20213 May 2023

First posted7 Oct 2021
Study start16 Nov 2021
Primary completion3 May 2023
Study completion3 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Moderate Renal ImpairmentStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070390
Sponsor's protocol ID: 0616-007
Other IDs: MK-0616-007
Status last verified: Jul 2026
First submitted: 1 Oct 2021
Last updated: 19 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Active, not recruitingPhase 1
A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
Renal Impairments, IgA Nephropathy (IgAN)

All Moderate Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Clinical Study to Evaluate the Pharmacokinetics of MK-0616 Following Administration of a Single Dose to Participants With Moderate Renal Impairment
ClinicalTrials.gov ID: NCT05070390
Acronym / sponsor ID: 0616-007
Conditions: Moderate Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Nov 2021 (actual)
Primary completion: 3 May 2023 (actual)
Study completion: 3 May 2023 (actual)
First posted: 7 Oct 2021 (actual)
Results: Posted 26 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Panel A - Moderate Renal Impairment (RI)	Experimental	Drug: Enlicitide ChlorideSingle dose of enlicitide chloride 10 mg
Panel B - Healthy Controls	Experimental	Drug: Enlicitide ChlorideSingle dose of enlicitide chloride 10 mg

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Good health based upon medical history, physical examination, vital signs, laboratory safety tests, and electrocardiograms (ECG) performed before randomization
Body mass index (BMI) ≥18 kg/m^2 and ≤40 kg/m^2
Male participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm, PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent, or use acceptable contraception per study protocol
Female participants must be of non-childbearing potential
Moderate RI participants: Baseline estimated glomerular filtration rate (eGFR) ≥30 and <60 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) equation

Key exclusion criteria (12 listed)

Healthy Matched Controls: history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator
History of cancer, with the exception of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study
History of significant multiple and/or severe allergies
Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enlicitide ChlorideAlso: MK-061610 mg capsule administered orally	Drug	Panel A - Moderate Renal Impairment (RI), Panel B - Healthy Controls

Primary outcome

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-0616. AUC0-inf was defined as the area under the concentration-time curve of MK-0616 from time zero to infinity.
Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration.
Maximum Plasma Concentration (Cmax) of MK-0616
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Blood samples were collected at pre-specified time points to determine the Cmax of MK-0616. Cmax was defined as the maximum concentration of MK-0616 reached.
Time to Maximum Plasma Concentration (Tmax) of MK-0616
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Blood samples were collected at pre-specified timepoints to determine the Tmax of MK-0616. Tmax was defined as time to the maximum concentration of MK-0616 reached.
Apparent Terminal Half-life (t1/2) of MK-0616
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Blood samples were collected at pre-specified timepoints to determine the t1/2 of MK-0616. t1/2 was defined as the time required to divide the MK-0616 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-0616.
Apparent Clearance (CL/F) of MK-0616
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma.
Apparent Volume of Distribution (Vz/F) of MK-0616
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration.

6 secondary outcomes

Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 14 days
Number of Participants Who Discontinued From the Study Due to an AE
Time frame: Up to approximately 14 days
Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616
Time frame: Predose and at 0, 4, 8, 12 and 24 hours postdose
Fraction of Dose Recovered in Urine (Fe) of MK-0616
Time frame: Predose and at 0, 4, 8, 12, 24, 36 and 48 hours postdose
Renal Clearance (CLr) of MK-0616
Time frame: Predose and 4, 8, 12, 24, 36, and 48 hours postdose
Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9)
Time frame: Baseline (Predose) and up to 336 hours post dose

Results and safety

Results posted to the registry on 26 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel A - Moderate Renal Impairment (RI)	10	10
Panel B - Healthy Controls	8	8

Primary outcome: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616

Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose. Geometric mean (95% Confidence Interval). Unit: hour*nmol/Liter

Measure	Panel A - Moderate Renal Impairment (RI) n = 7	Panel B - Healthy Controls n = 6
Value	453 (211 to 972)	369 (211 to 646)

Panel A - Moderate Renal Impairment (RI) vs Panel B - Healthy Controls: Geometric Mean Ratio (GMR): 1.23 (90% CI 0.62 to 2.44)

Population analysed: All allocated participants who received a dose of study intervention and had data available for AUC0-inf.

Primary outcome: Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616.

Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose. Geometric mean (95% Confidence Interval). Unit: hour*nmol/Liter

Measure	Panel A - Moderate Renal Impairment (RI) n = 8	Panel B - Healthy Controls n = 8
Value	312 (120 to 815)	192 (64.1 to 574)

Panel A - Moderate Renal Impairment (RI) vs Panel B - Healthy Controls: GMR: 1.63 (90% CI 0.55 to 4.83)

Population analysed: All allocated participants who received a dose of study intervention and had data available for AUC0-last.

Primary outcome: Maximum Plasma Concentration (Cmax) of MK-0616

Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose. Geometric mean (95% Confidence Interval). Unit: nmol/Liter

Measure	Panel A - Moderate Renal Impairment (RI) n = 8	Panel B - Healthy Controls n = 8
Value	5.80 (2.98 to 11.3)	4.00 (1.97 to 8.13)

Panel A - Moderate Renal Impairment (RI) vs Panel B - Healthy Controls: GMR: 1.45 (90% CI 0.70 to 2.99)

Population analysed: All allocated participants who received a dose of study intervention and had data available for Cmax.

Primary outcome: Time to Maximum Plasma Concentration (Tmax) of MK-0616

Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose. Median (Full Range). Unit: Hour

Measure	Panel A - Moderate Renal Impairment (RI) n = 8	Panel B - Healthy Controls n = 8
Value	2.00 (1.00 to 24.00)	4.66 (1.50 to 24.02)

Population analysed: All allocated participants who received a dose of study intervention and had data available for Tmax.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 16 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel A - Moderate RI	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Panel B - Healthy Controls	0 of 8 (0%)	2 of 8 (25%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Moderate Renal Impairment

Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Pruritus, Chronic Kidney Diseases
Active, not recruitingPhase 1
A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment
Renal Impairments, IgA Nephropathy (IgAN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Enlicitide Chloride in people with Moderate Renal Impairment, run by Merck Sharp & Dohme LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616 (time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.