Hypercholesterolemia MedDRA version: 21.0 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861
Conditions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meets 1 of the following ASCVD status/risk categories AND has a fasted LDL-C value in the corresponding LDL-C range at Visit 1 (Screening) • Has clinical ASCVD • Has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event that is =7.5% • Has a 10-year risk of having an ASCVD event that is =5.0% and =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1. Has a history of homozygous FH based on genetic or clinical criteria [Cuchel, M., et al 2014]. 2. Has a history of nephrotic syndrome. 3. Has any clinically significant malabsorption condition. 4. Had unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Visit 1 (Screening). 5. Has a planned coronary revascularization procedure within the next 3 months after Visit 1 (Screening). 6. Has poorly controlled diabetes mellitus, defined as A1C =9.0%, at Visit 1 (Screening). 7. Has a known allergy or intolerance to any ofthe ingredients in the study intervention. 8. Has a history of malignancy =3 years before Visit 1 (Screening), except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to Visit 1 (Screening). 9. Has a severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or administration of study intervention or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the participant inappropriate for entry into this study. 10. Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening). 11. Is receiving treatment with oral semaglutide at Visit 1 (Screening). 12. Meets 1 or more of the following criteria: • Is on treatment with a PCSK9 inhibitor (siRNA or mAb), an ANGPTL3 inhibitor, or an MTP inhibitor (eg, lomitapide) at Visit 1 (Screening). • Was previously treated with an siRNA PCSK9 inhibitor within 1 year before Visit 1 (Screening). • Was previously treated with a mAb PCSK9 inhibitor within 6 months before Visit 1 (Screening). • Was previously treated with an ANGPTL3 inhibitorwithin 6 months before Visit 1 (Screening). • Was previously treated with an MTP inhibitor (eg, lomitapide) within 1 month before Visit 1 (Screening). 13. Is currently participating in or has previously participated in an interventional clinical study within 3 months (or 5 half-lives for agents in the previous study, whichever is longer) before Visit 1 (Screening). 14. Has moderate or greater renal insufficiency defined as eGFR 2X ULN at Visit 1 (Screening). • A history of hepatitis or liver disease that, in the opinion of the investigator, has been active within the 6 months before Visit 1 (Screening) and may increase the risk associated with study participation or administration of study intervention. 16. Has elevated CK >3X ULN at Visit 1 (Screening). 17. Has a fasting triglyceride value =400 mg/dL (=4.52 mmol/L) at Visit 1 (Screening). 18. Has an abnormal TSH value at Visit 1 (Screening) without a history of hypothyroidism. Participants with a history of hypothyroidism are eligible if their treatment for this condition is stable for =3 months before Visit 1 (Screening) and their FT4 value at Visit 1 (Screening) is normal. 19. Routinely consumes >3 alcoholic drinks per day. One standard drink is defined as any beverage containing 14 g of pure alcohol (ie, 12 oz of beer, 8 to 9 oz of malt liquor, 5 oz of wine, 1.5 oz of distilled spirits). 20. Has
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the effect of MK-0616 with the effect of placebo on percent change from baseline in LDL-C at Week 8. 2. To evaluate the safety and tolerability of each dose of MK-0616. ;Secondary Objective: 1. To compare the effect of MK-0616 with the effect of placebo on percent change from baseline in ApoB and non-HDL-C at Week 8. 2. To compare the effect of MK-0616 with the effect of placebo on the proportion of participants with LDL-C value at goal at Week 8.;Primary end point(s): 1. Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8 2. Proportion of Participants Who Experience One or More Adverse Events (AEs) 3.Proportion of Participants Who Discontinue Study Intervention Due to AEs;Timepoint(s) of evaluation of this end point: 1. Baseline and Week 8 2. Up to approximately 16 Weeks 3. Up to approximately 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8 2. Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (HDL-C) at Week 8 3. Proportion of Participants with LDL-C Value at Goal at Week 8 ;Timepoint(s) of evaluation of this end point: 1. Baseline and Week 8 2. Baseline and Week 8 3. Up to 8 Weeks | — |
Countries
Germany, Japan, Korea, Republic of, Mexico, Norway, Russian Federation, Turkey, United Kingdom, United States
Contacts
Public ContactGCTO
Merck Sharp & Dohme LLC
Outcome results
None listed