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PCSK9 Inhibitor

Oral PCSK9 Inhibitor for High Cholesterol

Q: How many participants are currently included in this research?

<p>Merck Sharp &#x26; Dohme LLC, the sponsor of this trial, requires 270 eligible participants to commence operations. This clinical research is set to be conducted at Velocity Clinical Research at The Pioneer Heart Institute in Lincoln, <a href="https://www.withpower.com/clinical-trials/nebraska">Nebraska</a> as well as Jubilee Clinical Research in Las Vegas, <a href="https://www.withpower.com/clinical-trials/nevada">Nevada</a>.</p>

Q: What are the core goals of this medical research?

<p>The trial sponsor, Merck Sharp &#x26; Dohme LLC, has stated that the primary outcome of this study will be evaluated over a Baseline and Week 24 period. This involves measuring how many patients experience adverse events (AEs). Further assessments are being conducted to determine the Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24, Percentage of participants with LDL-C lower than 70 mg/dL and ≥50% reduction from baseline at week 24, as well as Percent change from baseline in lipoprotein(a) (Lp[a]) at week 24.</p>

Phase 3

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

Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change

Is treated with a moderate- or high-intensity statin medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~60 weeks

Awards & highlights

Study Summary

This trial tests if a drug called MK-0616 can reduce cholesterol levels in people with an inherited form of high cholesterol.

Who is the study for?

This trial is for adults with a condition called heterozygous familial hypercholesterolemia, which causes high cholesterol. Participants must have LDL-C levels above certain thresholds and be on stable doses of statins or other lipid-lowering therapies without plans to change them.Check my eligibility

What is being tested?

The study tests MK-0616, an oral medication intended to lower 'bad' cholesterol (LDL-C), against a placebo. The main goal is to see if MK-0616 can significantly reduce LDL-C levels after 24 weeks compared to the placebo.See study design

What are the potential side effects?

While specific side effects are not listed here, generally PCSK9 inhibitors like MK-0616 could cause symptoms such as nasal congestion, sneezing, sore throat, injection site reactions (if injectable), and back pain.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am on a consistent dose of my cholesterol medications with no changes expected.

Select...

I am currently taking a strong cholesterol-lowering medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~60 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

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24

Number of participants who discontinue study drug due to an AE

Number of participants with one or more adverse events (AEs)

Secondary outcome measures

Mean percent change from baseline in LDL-C at Week 52

Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24

Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24

+3 more

Side effects data

From 2022 Phase 2 trial • 381 Patients • NCT05261126

Dyspepsia

Arthralgia

Fatigue

Nausea

Cholecystitis

COVID-19

Deep vein thrombosis

Diarrhoea

100%

80%

60%

40%

20%

Study treatment Arm

MK-0616 12 mg

MK-0616 18 mg

MK-0616 30 mg

Placebo

MK-0616 6 mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-0616Experimental Treatment1 Intervention

Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-0616

2023

Completed Phase 2

~440

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,276 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

8,063,210 Total Patients Enrolled

2 Trials studying High Cholesterol

14,583 Patients Enrolled for High Cholesterol

Media Library

MK-0616 (PCSK9 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05952869 — Phase 3

High Cholesterol Research Study Groups: MK-0616, Placebo

High Cholesterol Clinical Trial 2023: MK-0616 Highlights & Side Effects. Trial Name: NCT05952869 — Phase 3

MK-0616 (PCSK9 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05952869 — Phase 3

Frequently Asked Questions

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

Is MK-0616 safe to consume for human consumption?

"The safety profile of MK-0616 was rated at 3 due to the multiple rounds of data collected during Phase 3 trials, which suggest that this drug is both efficacious and safe."

Answered by AI

Are there multiple sites where this research is being conducted?

"Currently, this medical trial has 4 sites where patients can be recruited. These locations are in Lincoln, Las Vegas and West Jordan as well as 4 others. Those interested should pick the nearest clinic to reduce commuting demands if enrolled."

Answered by AI

How many participants are currently included in this research?

"Merck Sharp & Dohme LLC, the sponsor of this trial, requires 270 eligible participants to commence operations. This clinical research is set to be conducted at Velocity Clinical Research at The Pioneer Heart Institute in Lincoln, Nebraska as well as Jubilee Clinical Research in Las Vegas, Nevada."

Answered by AI

Are there any openings for participation in this trial?

"Affirmative. The clinicaltrial.gov database shows that the research, initially posted on August 8th 2023 is currently recruiting participants. Currently, 270 people need to be recruited from 4 different sites for this experiment."

Answered by AI

What are the core goals of this medical research?

"The trial sponsor, Merck Sharp & Dohme LLC, has stated that the primary outcome of this study will be evaluated over a Baseline and Week 24 period. This involves measuring how many patients experience adverse events (AEs). Further assessments are being conducted to determine the Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24, Percentage of participants with LDL-C lower than 70 mg/dL and ≥50% reduction from baseline at week 24, as well as Percent change from baseline in lipoprotein(a) (Lp[a]) at week 24."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH

2023. "A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05952869.

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