Enclitide Chloride for High Cholesterol

No longer recruiting at 72 trial locations

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Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Lipid-lowering therapies

Disqualifiers: Homozygous FH, Unstable angina, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, enclitide chloride (also known as MK-0616), to determine if it can safely and effectively lower LDL cholesterol, often referred to as "bad" cholesterol. Participants will receive one of four different doses of this medication or a placebo for eight weeks. The goal is to identify which dose best reduces cholesterol levels. The trial seeks individuals with high cholesterol, a history of heart-related issues, and who have either been on stable cholesterol medication or not on any for at least 30 days. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cholesterol management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable dose of lipid-lowering therapies for at least 30 days before screening, or not have taken any for the same period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that enclitide chloride, a pill that lowers cholesterol, has a good safety record in earlier studies. These studies found that people usually tolerate the treatment well. Specifically, enclitide chloride reduced levels of LDL cholesterol, often called "bad" cholesterol, at various doses compared to a placebo. Importantly, no major side effects were reported at any dose level tested, meaning participants did not experience serious health issues during the trials. Overall, the treatment appears safe based on current evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Enclitide Chloride (MK-0616) because it brings a fresh approach to managing hypercholesterolemia. Unlike traditional treatments like statins, which primarily work by blocking the liver's cholesterol production, Enclitide Chloride is a PCSK9 inhibitor that targets a different pathway to reduce LDL cholesterol levels. This oral medication offers a potentially more convenient option compared to injectable PCSK9 inhibitors currently available. By providing an innovative mechanism of action and a user-friendly delivery method, Enclitide Chloride could significantly enhance patient adherence and outcomes in controlling cholesterol levels.

What evidence suggests that this trial's treatments could be effective for lowering LDL-C in hypercholesterolemia?

Studies have shown that enclitide chloride, a pill that lowers cholesterol, effectively reduces "bad" cholesterol levels in people with high cholesterol. Research indicates that this treatment can significantly lower these levels. Previous studies demonstrated that higher doses of the medication led to greater reductions in cholesterol. This trial will test various doses of enclitide chloride, ranging from 6 mg to 30 mg, to evaluate its effectiveness in managing high cholesterol. ^{2 3 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening.

Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening.

You are female and not pregnant, not a WOCBP and agree to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enclitide chloride or placebo orally once daily for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-0616
• Placebo

How Is the Trial Designed?

Group I: Enclitide Chloride 6 mg Experimental Treatment 1 Intervention

Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks

Group II: Enclitide Chloride 30 mg Experimental Treatment 1 Intervention

Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks

Group III: Enclitide Chloride 18 mg Experimental Treatment 1 Intervention

Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks

Group IV: Enclitide Chloride 12 mg Experimental Treatment 1 Intervention

Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks

Group V: Placebo Placebo Group 1 Intervention

Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05261126

A Study of the Efficacy and Safety of Enclitide Chloride (MK ... The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein ...

2. merck.com merck.com/news/mercks-investigational-oral-pcsk9-inhibitor-enlicitide-decanoate-met-all-primary-and-key-secondary-endpoints-in-adults-with-hypercholesterolemia-in-pivotal-coralreef-lipids-study/

Merck's Investigational Oral PCSK9 Inhibitor Enlicitide ... Treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05261126?term=008%200045&viewType=Table&checkSpell=&rank=1&tab=results

A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36889610/

Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor ... Conclusions: MK-0616 demonstrated statistically significant and robust, dose-dependent placebo-adjusted reductions in LDL-C at Week 8 of up to ...

5. merck.com merck.com/news/merck-announces-positive-topline-results-from-the-first-two-phase-3-coralreef-trials-evaluating-enlicitide-decanoate-for-the-treatment-of-adults-with-hyperlipidemia/

Merck Announces Positive Topline Results From the First ... Enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C in both Phase 3 CORALreef HeFH and CORALreef AddOn trials.

6. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-P4153/Enlicitide-chloride-SDS-MedChemExpress.pdf

Enlicitide chloride-SDS-MedChemExpress For disposal see section 13. 7. HANDLING AND STORAGE. 7.1 Precautions for safe handling. Avoid inhalation, contact with eyes and skin. Avoid ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07058077

NCT07058077 | A Study of Enlicitide Decanoate (MK-0616 ... The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if ...

8. msd.com msd.com/news/msds-mk-0616-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-patients-with-hypercholesterolemia-in-phase-2b-study/

MSD's MK-0616, an Investigational Oral PCSK9 Inhibitor ... March 6, 2023 1:23 pm EST. MK-0616 was generally well tolerated and reduced LDL-C across all dose levels compared to placebo.