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PCSK9 Inhibitor

MK-0616 for High Cholesterol

Phase 2
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 up to approximately 17 weeks
Awards & highlights

Study Summary

This trial is testing whether or not an oral drug called MK-0616 can lower LDL-C (bad cholesterol) in people with hypercholesterolemia (high cholesterol). The primary hypothesis is that at least one of the four doses of MK-0616 tested is better than placebo at lowering LDL-C at Week 8.

Eligible Conditions
  • High Cholesterol

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 17 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 17 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8
Percentage of Participants Who Discontinued Study Intervention Due to AEs
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
Secondary outcome measures
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8
Percentage of Participants With LDL-C Value at Goal at Week 8

Side effects data

From 2022 Phase 2 trial • 381 Patients • NCT05261126
7%
Dyspepsia
5%
Arthralgia
4%
Fatigue
1%
Nausea
1%
Cholecystitis
1%
COVID-19
1%
Deep vein thrombosis
1%
Diarrhoea
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

5Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-0616 6 mgExperimental Treatment1 Intervention
Participants will receive 6 mg of MK-0616 orally QD for 8 weeks
Group II: MK-0616 30 mgExperimental Treatment1 Intervention
Participants will receive 30 mg of MK-0616 orally QD for 8 weeks
Group III: MK-0616 18 mgExperimental Treatment1 Intervention
Participants will receive 18 mg of MK-0616 orally QD for 8 weeks
Group IV: MK-0616 12 mgExperimental Treatment1 Intervention
Participants will receive 12 mg of MK-0616 orally QD for 8 weeks
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive MK-0616-matching placebo orally QD for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-0616
2023
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,447 Total Patients Enrolled
2 Trials studying High Cholesterol
1,649 Patients Enrolled for High Cholesterol
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,172 Total Patients Enrolled
5 Trials studying High Cholesterol
14,762 Patients Enrolled for High Cholesterol
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,105 Total Patients Enrolled
2 Trials studying High Cholesterol
14,583 Patients Enrolled for High Cholesterol

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Northeast Clinical Research of San Antonio ( Site 0014)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
2022. "A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05261126.
~124 spots leftby Apr 2025
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