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Monoclonal Antibodies

Oral PCSK9 Inhibitor for High Cholesterol

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up periods 1 and 2: predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose (each period = 15 days
Awards & highlights

Study Summary

This trial will compare the effect of a single dose of a drug in people with varying degrees of kidney impairment to healthy controls.

Who is the study for?
This trial is for adults with high cholesterol who are on a stable statin therapy and have varying degrees of kidney problems, from moderate to severe or end-stage renal disease. They should be generally healthy otherwise, but can have chronic conditions like hypertension or diabetes if they're stable. People with gastrointestinal issues affecting drug absorption, recent cancer history, renal artery stenosis, past significant allergies or reactions to drugs cannot participate.Check my eligibility
What is being tested?
The study tests MK-0616, an oral PCSK9 inhibitor designed to lower cholesterol levels. It aims to understand how the drug behaves in the bloodstream after a single dose in people with different levels of kidney health compared to healthy individuals also on statins. There's no hypothesis; it's about observing differences in drug processing.See study design
What are the potential side effects?
While specific side effects for MK-0616 aren't listed here, PCSK9 inhibitors may commonly cause symptoms like cold-like signs (runny nose or sore throat), injection site reactions if injectable (not applicable here as MK-0616 is oral), flu symptoms, back pain and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~periods 1 and 2: predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose (each period = 15 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and periods 1 and 2: predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose (each period = 15 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Panel A, B and D: Apparent Clearance (CL/F) of MK-0616: Period 1
Panel A, B, and D: Time to Maximum Plasma Concentration (Tmax) of MK-0616: Period 1
Panel C: AUC0-inf of MK-0616: Periods 1 and 2
+11 more
Secondary outcome measures
Amount of MK-0616 Excreted (AEd) in Dialysate
Amount of MK-0616 Excreted in Urine from 0 to 24 hours (AE0-24)
Dialysate Clearance (CLd) of MK-0616
+6 more

Side effects data

From 2022 Phase 2 trial • 381 Patients • NCT05261126
7%
Dyspepsia
5%
Arthralgia
4%
Fatigue
1%
Nausea
1%
Cholecystitis
1%
Deep vein thrombosis
1%
Diarrhoea
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-0616 12 mg
MK-0616 18 mg
MK-0616 30 mg
Placebo
MK-0616 6 mg

Trial Design

4Treatment groups
Experimental Treatment
Group I: Panel D: HealthyExperimental Treatment1 Intervention
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
Group II: Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)Experimental Treatment1 Intervention
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days). Period 2 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 2 = 15 days). A washout period of 14 days will separate Period 1 and Period 2.
Group III: Panel B: Severe RIExperimental Treatment1 Intervention
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
Group IV: Panel A: Moderate Renal Impairment (RI)Experimental Treatment1 Intervention
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-0616
2023
Completed Phase 2
~440

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 LLCLead Sponsor
3,907 Previous Clinical Trials
5,065,985 Total Patients Enrolled
4 Trials studying High Cholesterol
14,729 Patients Enrolled for High Cholesterol
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,067,219 Total Patients Enrolled
1 Trials studying High Cholesterol
14,550 Patients Enrolled for High Cholesterol

Media Library

MK-0616 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05934292 — Phase 1
High Cholesterol Research Study Groups: Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD), Panel D: Healthy, Panel B: Severe RI, Panel A: Moderate Renal Impairment (RI)
High Cholesterol Clinical Trial 2023: MK-0616 Highlights & Side Effects. Trial Name: NCT05934292 — Phase 1
MK-0616 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05934292 — Phase 1
~18 spots leftby Jun 2025
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