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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3,000
Oral tablet
Number of participants with 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.
Time frame: Up to approximately 3 years
Number of participants who discontinue study drug 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.
Time frame: Up to approximately 3 years
Mean percent change from baseline of the parent study in LDL-C at 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.
Time frame: Baseline of the parent study and Week 8 of this extension study
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
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.
Time frame: Baseline of the parent study and Week 8 of this extension study
Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at 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.
Time frame: Baseline of the parent study and Week 8 of this extension study
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Alliance for Multispecialty Research, LLC ( Site 0027)
Daphne, Alabama, United States
G&L Research ( Site 0035)
Foley, Alabama, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
Phoenix, Arizona, United States
National Heart Institute-Research ( Site 0029)
Beverly Hills, California, United States
Clinical Trials Research ( Site 0054)
Sacramento, California, United States
Velocity Clinical Research, Banning ( Site 0023)
San Bernardino, California, United States
Emerson Clinical Research Institute ( Site 0017)
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials ( Site 0010)
Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0037)
Doral, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0056)
Fort Myers, Florida, United States
...and 212 more locations
Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at 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.
Time frame: Baseline of the parent study and Week 8 of this extension study
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent 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.
Time frame: Baseline in the parent study and up to approximately 3 years in this extension study
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent 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.
Time frame: Baseline in the parent study and up to approximately 3 years in this extension study