Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolaemia

Treatments: Drug: Enlicitide Decanoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05934292

0616-020

MK-0616-020 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Panel C included participants with ESRD. No urine samples could be obtained on Panel C participants and hence no pharmacokinetic (PK) analysis could be performed for Panel C participants as pre-specified in the protocol.

Enrollment: 33 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be in good health with the exception of renal impairment (RI) and hypercholesterolemia for participants in Panels A, B, and C. Participants with RI that have stable, chronic medical or psychiatric conditions, including but not limited to hypertension, hypercholesterolemia, diabetes mellitus, hyper- or hypothyroidism, gout, and chronic anxiety or depression may be included at the discretion of the investigator
• Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 40 kg/m^2, inclusive
• Be on a stable dose of any statin therapy defined as: no changes to dose or type of statin therapy for at least 2 months prior to Screening and participant anticipates no changes to statin therapy throughout the study until the poststudy visit

Exclusion criteria

• History or presence of renal artery stenosis
• Had a functioning renal transplant in the past 5 years and is taking transplant medication
• Participants in panels A, B and D: Has rapidly fluctuating renal function as determined by historical measurements
• Has a history gastrointestinal disease which might affect food and drug absorption, as determined by the investigator, or has had gastric bypass or similar surgery
• History of cancer (malignancy)
• History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
• Has received an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) small molecule treatment, monoclonal antibody, or short interfering RNA (siRNA) or RNA interference (ie, Inclisiran) within 12 months prior to Screening
• Participants with RI (Panels A, B, and C): Taking medications to treat chronic medical conditions and/or conditions associated with renal disease, if participant has not been on a stable regimen for at least 1 month (other than statins, which require a stable dose for at least 2 months) prior to administration of the initial dose of study intervention, and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 4 hours after administration of study intervention
• Participated in another investigational study within 4 weeks prior to the prestudy (screening) visit
• Consumes greater than 3 servings of alcoholic beverages per day
• Consumes excessive amounts, defined as greater than 6 servings of caffeinated beverages per day

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Panel A: Moderate Renal Impairment (RI)

Experimental group

Description:

Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1

Treatment:

Drug: Enlicitide Decanoate

Panel B: Severe RI

Experimental group

Description:

Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1

Treatment:

Drug: Enlicitide Decanoate

Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)

Experimental group

Description:

Participants receive Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.

Treatment:

Drug: Enlicitide Decanoate

Panel D: Healthy Controls

Experimental group

Description:

Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.

Treatment:

Drug: Enlicitide Decanoate