Enlicitide Decanoate for High Cholesterol
Recruiting in Palo Alto (17 mi)
+35 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Merck Sharp & Dohme LLC
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide decanoate is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.
Do I need to stop my current medications for this trial?
The trial requires you to stay on a stable dose of your current lipid-lowering therapies (LLTs) without any planned changes during the study. If you are taking certain cholesterol-lowering medications like ezetimibe, bempedoic acid, or PCSK9 inhibitors, you may need an adequate washout period before starting the trial.
What data supports the idea that Enlicitide Decanoate for High Cholesterol is an effective drug?
The available research shows that drugs targeting PCSK9, like Enlicitide Decanoate, are effective in lowering bad cholesterol levels, known as LDL-C. These drugs have been shown to improve heart health outcomes when used alongside other treatments. They are particularly useful for people who do not respond well to traditional cholesterol-lowering medications. Studies have demonstrated that PCSK9 inhibitors can significantly reduce the risk of heart attacks and strokes by lowering LDL-C levels.
12345What safety data is available for Enlicitide Decanoate (MK-0616) for high cholesterol?
The safety data for PCSK9 inhibitors, which include Enlicitide Decanoate (MK-0616), indicates a generally favorable safety profile in clinical trials. However, real-world data shows some adverse events such as injection-site reactions, influenza-like illness, and myalgia. Neurocognitive adverse reactions and ocular disorders have also been reported, but the long-term safety remains unclear. Most adverse events resolve over time, and no specific patient subgroup at risk has been identified.
678910Is the drug Enlicitide Decanoate a promising treatment for high cholesterol?
Yes, Enlicitide Decanoate, which is a type of PCSK9 inhibitor, is a promising treatment for high cholesterol. PCSK9 inhibitors are known to significantly lower bad cholesterol (LDL-C) levels and reduce the risk of heart attacks and strokes. They are especially useful for people who do not respond well to traditional cholesterol-lowering drugs.
2341112Eligibility Criteria
This trial is for adults with high cholesterol who may have had a cardiovascular event or are at risk of one. They must be on a stable dose of statins, possibly with other lipid-lowering treatments, and meet specific LDL-C levels based on their heart disease history.Inclusion Criteria
Has fasted lipid values at Visit 1 (Screening) meeting specific LDL-C criteria based on ASCVD history
I am on a stable dose of my current medications with no changes expected.
I am 18 years or older and can give informed consent.
+2 more
Exclusion Criteria
I have a genetic condition that causes very high cholesterol.
I was treated with cholesterol medications recently without a break.
I am part of, or plan to join, an LDL cholesterol cleaning program.
+3 more
Participant Groups
The study tests if Enlicitide Decanoate (an oral PCSK9 inhibitor) is better than Ezetimibe, Bempedoic Acid, or their combination in lowering 'bad' cholesterol (LDL-C). Participants will receive either the test drug or placebos to compare effects after 8 weeks.
4Treatment groups
Experimental Treatment
Active Control
Group I: Enlicitide DecanoateExperimental Treatment3 Interventions
Participants receive enlicitide decanoate 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.
Group II: Ezetimibe + Bempedoic AcidActive Control3 Interventions
Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide decanoate-matching placebo orally QD for approximately 56 days.
Group III: EzetimibeActive Control3 Interventions
Participants receive ezetimibe 10mg, enlicitide decanoate-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.
Group IV: Bempedoic AcidActive Control3 Interventions
Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide decanoate-matching placebo QD orally up to approximately 56 days.
Enlicitide Decanoate is already approved in United States for the following indications:
🇺🇸 Approved in United States as Enlicitide Decanoate for:
- Hypercholesterolemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical Trials Research ( Site 1509)Lincoln, CA
Healthcare Research Network - Chicago ( Site 1507)Flossmoor, IL
L-MARC Research Center ( Site 1501)Louisville, KY
Velocity Clinical Research Rockville ( Site 1503)Rockville, MD
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLCLead Sponsor
References
PCSK9 inhibition in clinical practice: Treatment patterns and attainment of lipid goals in a large health maintenance organization. [2021]Proprotein convertase subtilisin/kexin type-9 inhibitors (PCSK9i) effectively reduce low-density lipoprotein cholesterol (LDL-C), improving cardiovascular outcomes in clinical trials when added to statin therapy.
A Retrospective Chart Review Evaluating Efficacy, Tolerability, and Cost of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9i) in Older Adults. [2021]Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are proven to have profound lowering of low-density lipoprotein cholesterol (LDL-C) in patients with clinical atherosclerotic cardiovascular disease or familial hypercholesterolemia.
Prevention of myocardial infarction and stroke with PCSK9 inhibitors treatment: a metanalysis of recent randomized clinical trials. [2022]Proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors treatment induce large reductions in low-density lipoprotein cholesterol (LDLc) and major cardiovascular events. Clinical trials might have been underpowered to test the effect of PSCK9 inhibitors treatment on myocardial infarction and stroke, two of the most relevant cardiovascular events, since all analyzed a combined endpoint.
Proprotein convertase subtilisin/kexin type 9: a new target molecule for gene therapy. [2021]Proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged as a novel target for controlling plasma levels of low-density lipoprotein cholesterol (LDL-C) and decreasing the risk of cardiovascular diseases. At present it is clear that the major classes of commonly prescribed lipid-lowering medications increase serum PCSK9 levels and fail to protect a significant percentage of patients from cardiovascular events. Therefore development of new LDL-C lowering medications that either do not increase circulating PCSK9 levels or work through inhibition of PCSK9 expression and protease activity is a highly desirable approach to overcome hypercholesterolemia. Since there are several agents which are being evaluated in human preclinical and clinical trials, this review summarizes current therapeutic strategies targeting PCSK9, including specific antibodies, antisense oligonucleotides, small interfering RNAs (siRNAs) and other small-molecule inhibitors.
Innovative, centralised, multidisciplinary medicines optimisation clinic for PCSK9 inhibitors. [2022]Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) are an important but underutilised option to help optimise lipid management. We developed a new service to improve patient access to these medicines in line with National Institute for Health and Care Excellence recommendations. This paper describes the model and provides lipid-lowering results and feedback from the first 100 referred patients.
Ocular disorders associated with PCSK9 inhibitors: A pharmacovigilance disproportionality analysis. [2023]To identify and characterize ocular adverse events (oAEs) that are significantly associated with proprotein convertase subtilisin-like/kexin type 9 (PCSK9) inhibitors using the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Proprotein convertase subtilisin/kexin type 9 inhibitors for reduction of cardiovascular events. [2021]The efficacy, safety, and place in therapy of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors for lipid lowering are reviewed.
Increased Risk of Adverse Neurocognitive Outcomes With Proprotein Convertase Subtilisin-Kexin Type 9 Inhibitors. [2021]There is encouraging evidence of the efficacy of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors; however, their long-term safety remains unclear. We performed a meta-analysis of studies to evaluate the long-term safety of PCSK9 inhibitors.
Adverse Events Associated With PCSK9 Inhibitors: A Real-World Experience. [2021]In randomized clinical trials (RCTs) proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors showed a favorable safety profile, however, "real-world" data on adverse events (AEs) is scarce. Three datasets, a hospital registry (n = 164), and two Pharmacovigilance databases, Lareb (n = 149) and VigiLyze (n = 15,554), reporting AEs attributed to PCSK9 inhibitors (alirocumab or evolocumab) prescribed in clinical practice were analyzed. In the hospital registry, 41.5% of the patients reported any AE, most often injection-site reactions (33.8%) and influenza-like illness (27.9%). Twelve patients (7%) discontinued PCSK9 inhibitor treatment. Most common AE reported in the Lareb and VigiLyze database was myalgia (12.8% and 8.3%, respectively). No clinically relevant differences in gender or between drugs were observed. No specific subgroup of patients could be identified at risk of developing AEs. During follow-up, AEs resolved in most patients (71.1%). In a real-world setting, PCSK9 inhibitors are well tolerated with an overall safety profile comparable to RCTs.
PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database. [2023]Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs).
Use of PCSK9 Inhibitors in Solid Organ Transplantation Recipients. [2021]Standard lipid-lowering therapies in solid organ transplantations pose challenges due to interactions with immunosuppressants. Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represent a new class of lipid-lowering therapies with potential promise in this population. We describe PCSK9i as an efficacious and safe option for management of hypercholesterolemia in solid organ transplantations. (Level of Difficulty: Advanced.).
Trends in PCSK9 Inhibitor Prescriptions before and after the Price Reduction in Patients with Atherosclerotic Cardiovascular Disease. [2021]Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors reduce low-density lipoprotein (LDL) cholesterol and cardiovascular event rates, yet due to their high price remain underutilized and difficult to prescribe in clinical practice. In March 2018, their price was significantly reduced. We evaluated whether the price reduction would improve prescribing patterns of PCSK9 inhibitors in eligible patients with atherosclerotic cardiovascular disease (ASCVD).