A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
ConditionLipoprotein(a)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
MK-7262
DrugOral Coated Tablet
Enlicitide
DrugOral Coated Tablet
Placebo for MK-7262
DrugOral Coated Tablet
Placebo for enlicitide
DrugOral Coated Tablet
Treatment groups
750 Participants
are divided into 4 treatment groupsGroup A: PlaceboPlacebo comparator 2 interventions
Group B: enlicitide monotherapyActive comparator 2 interventions
Group C: MK-7262 monotherapyExperimental treatment 2 interventions
Group D: MK-7262 + enlicitideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a).
Time frame
Baseline and Week 82
Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.
Time frame
Baseline and Week 83
Number of Participants who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame
Up to approximately 20 Weeks4
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame
Up to approximately 12 WeeksSecondary outcomes
1
Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with enlicitide monotherapy versus placebo.
Time frame
Baseline and Week 82
Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 monotherapy versus placebo.
Time frame
Baseline and Week 83
Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in Lp(a) between participants treated with MK-7262 + enlicitide versus MK-7262 monotherapy.
Time frame
Baseline and Week 84
Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 + enlicitide versus enlicitide monotherapy.
Time frame
Baseline and Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov