Hypercholesterolemia
Conditions
Brief summary
This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).
Interventions
Oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study) * Had an overall study intervention compliance ≥80% while participating in their parent study
Exclusion criteria
* Has discontinued study intervention in their parent study * Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study * Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study * Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with one or more adverse events (AEs) | Up to approximately 3 years | 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. |
| Number of participants who discontinue study drug due to an AE | Up to approximately 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study | Baseline of the parent study and Week 8 of this extension study | The percent change from baseline in apolipoprotein B. Each participant's baseline data from their parent study will be used as baseline data for this analysis. |
| Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study | Baseline of the parent study and Week 8 of this extension study | The percent change from baseline in Lp(a). Each participant's baseline data from their parent study will be used as baseline data for this analysis. |
| Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study | Baseline of the parent study and Week 8 of this extension study | The percent change from baseline in LDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis. |
| Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study | Baseline in the parent study and up to approximately 3 years in this extension study | The percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis. |
| Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study | Baseline in the parent study and up to approximately 3 years in this extension study | The percentage of participants who have LDL-C \<70 mg/dL and ≥50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis. |
| Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study | Baseline of the parent study and Week 8 of this extension study | The percent change from baseline in Non-HDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis. |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed