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

Recruiting at 62 trial locations

Overseen By Toll Free Number

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

381 Participants Needed

Trial Summary

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.

How does the drug MK-0616 differ from other treatments for its condition?

MK-0616, also known as Enlicitide, is unique because it targets the TMEM16A calcium-activated chloride channel, which is involved in various physiological processes and diseases. This mechanism of action is different from many existing treatments, which may not specifically target this channel. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

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

Treatment Details

Interventions

• MK-0616
• Placebo

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Substituted 2-Acylaminocycloalkylthiophene-3-carboxylic Acid Arylamides as Inhibitors of the Calcium-Activated Chloride Channel Transmembrane Protein 16A (TMEM16A). [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Niclosamide potentiates TMEM16A and induces vasoconstriction. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Niclosamide repurposed for the treatment of inflammatory airway disease. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Synthesis, SAR, crystal structure, and biological evaluation of benzoquinoliziniums as activators of wild-type and mutant cystic fibrosis transmembrane conductance regulator channels. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Permeation Mechanisms in the TMEM16B Calcium-Activated Chloride Channels. [2018]