A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
Purpose
Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C). The goals of this trial are to evaluate: - if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood - if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood - the safety and tolerability of taking MK-7262 and enlicitide alone and together
Condition
- Lipoprotein(a)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
The main inclusion criteria include but are not limited to the following: - Has Lp(a) ≥ 150 nmol/L - Is receiving an optimized and stable dose of statin for ≥ 30 days with no planned additions, dose changes, or discontinuations through the duration of the study
Exclusion Criteria
The main exclusion criteria include but are not limited to the following: - Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH - Has a history of class IV heart failure, severe ventricular systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization - Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load) - Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection - Has a history of nephrotic syndrome - Has severe renal insufficiency - Has received certain therapies in the prohibited timeframe as specified in the protocol - Has active or chronic hepatobiliary or hepatic disease - Has poorly controlled Type 1 or Type 2 diabetes
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment. |
|
|
Active Comparator enlicitide monotherapy |
Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment. |
|
|
Experimental MK-7262 monotherapy |
Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment. |
|
|
Experimental MK-7262 + enlicitide |
Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment. |
|
Recruiting Locations
Mobile, Alabama 36608
Study Coordinator
251-414-1984
Lincoln, California 95648
Study Coordinator
916-434-8230
Waterbury, Connecticut 06708
Study Coordinator
203-419-4420
Miami Lakes, Florida 33014
Study Coordinator
786-502-4303
Tampa, Florida 33607
Study Coordinator
813-873-8102
Winter Park, Florida 32789
Study Coordinator
407-916-0060
Albuquerque, New Mexico 87106
Study Coordinator
505-855-5505
Kingsport, Tennessee 37660
Study Coordinator
423-857-2789
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC