Lipoprotein(a)
Conditions
Brief summary
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
Interventions
DRUGMK-7262
Oral Coated Tablet
DRUGEnlicitide
Oral Coated Tablet
DRUGPlacebo for MK-7262
Oral Coated Tablet
Oral Coated Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8 | Baseline and Week 8 | Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a). |
| Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 | Baseline and Week 8 | Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C. |
| Number of Participants who Experience One or More Adverse Events (AEs) | Up to approximately 20 Weeks | 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. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo) | Baseline and Week 8 | 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. |
| Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo) | Baseline and Week 8 | 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. |
| Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy) | Baseline and Week 8 | 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. |
| Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy) | Baseline and Week 8 | 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. |
| Percentage of Participants with Lp(a) <125 nmol/L at Week 8 | Week 8 | Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) \<125 nmol/L. The percentage of participants with Lp(a) \<125 nmol/L at week 8 will be reported. |
| Percentage of Participants with Lp(a) <75 nmol/L at Week 8 | Week 8 | Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) \<75 nmol/L. The percentage of participants with Lp(a) \<75 nmol/L at week 8 will be reported. |
| Percent Change from Baseline in Lp(a) at Week 12 | Baseline and Week 12 | Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in Lp(a). |
| Percent Change from Baseline in LDL-C at Week 12 | Baseline and Week 12 | Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in LDL-C. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed