The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
303
Oral tablet
Oral tablet (placebo).
Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Blood samples were collected at baseline and at Week 24 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Time frame: Baseline and Week 24
Number of Participants With Adverse Events (AEs)
An AE was defined as 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 64 weeks (8 weeks postdose)
Number of Participants Who Discontinued Study Drug Due to an AE
An AE was defined as 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 56 weeks
Mean Percent Change From Baseline in LDL-C at Week 52
Blood samples were collected at baseline and at Week 52 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Time frame: Baseline and Week 52
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Blood samples were collected at baseline and at Week 24 to determine mean percent change in non-HDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline non-HDL-C as a covariate.
Time frame: Baseline and Week 24
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Alliance for Multispecialty Research, LLC ( Site 0023)
Daphne, Alabama, United States
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, Florida, United States
Advanced Pharma Research ( Site 0007)
Cutler Bay, Florida, United States
Progressive Medical Research ( Site 0021)
Port Orange, Florida, United States
Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)
Winter Park, Florida, United States
Synexus Clinical Research US - Evansville ( Site 0031)
Evansville, Indiana, United States
Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)
Indianapolis, Indiana, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)
Troy, Michigan, United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)
Lincoln, Nebraska, United States
Jubilee Clinical Research ( Site 0030)
Las Vegas, Nevada, United States
...and 49 more locations
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Blood samples were collected at baseline and at Week 24 to determine mean percent change in ApoB. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline ApoB as a covariate.
Time frame: Baseline and Week 24
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
Blood samples were collected at baseline and at Week 24 to determine percent change in Lp(a). For percent change in Lp(a) at Week 24, the two treatment groups were analyzed using the Wilcoxon signed rank test with Hodges-Lehmann estimation.
Time frame: Baseline and Week 24
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24
Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C \<70 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
Time frame: Baseline and Week 24
Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24
Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C \<55 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
Time frame: Baseline and Week 24