← Back to Search

PCSK9 Inhibitor

A Study of the Efficacy and Safety of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

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

Summary

This trial is testing MK-0616, a pill that lowers bad cholesterol, in people with high cholesterol. It works by blocking a protein that raises bad cholesterol levels.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
COVID-19
1%
Nausea
1%
Cholecystitis
1%
Diarrhoea
1%
Deep vein thrombosis
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: Enlicitide Decanoate12 mgExperimental Treatment1 Intervention
Participants will receive 12 mg of enlicitide decanoate orally QD for 8 weeks
Group II: Enlicitide Decanoate 6 mgExperimental Treatment1 Intervention
Participants will receive 6 mg of enlicitide decanoate orally QD for 8 weeks
Group III: Enlicitide Decanoate 30 mgExperimental Treatment1 Intervention
Participants will receive 30 mg of enlicitide decanoate orally QD for 8 weeks
Group IV: Enlicitide Decanoate 18 mgExperimental Treatment1 Intervention
Participants will receive 18 mg of enlicitide decanoate orally QD for 8 weeks
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive enlicitide decanoate-matching placebo orally QD for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enlicitide Decanoate
2024
Completed Phase 2
~500

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,107 Total Patients Enrolled
2 Trials studying High Cholesterol
1,649 Patients Enrolled for High Cholesterol
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,422 Total Patients Enrolled
5 Trials studying High Cholesterol
14,762 Patients Enrolled for High Cholesterol
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,053 Total Patients Enrolled
2 Trials studying High Cholesterol
14,583 Patients Enrolled for High Cholesterol
~102 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top