The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with 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
2,912
Oral tablet
Oral tablet
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Time frame: Baseline and Week 24
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 ~60 weeks
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 ~52 weeks
Mean percent change from baseline in LDL-C at Week 52
Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.
Time frame: Baseline and Week 52
Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Time frame: Baseline and Week 24
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Time frame: Baseline and Week 24
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Alliance for Multispecialty Research, LLC ( Site 0093)
Daphne, Alabama, United States
G&L Research ( Site 0043)
Foley, Alabama, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
Phoenix, Arizona, United States
National Heart Institute-Research ( Site 0087)
Beverly Hills, California, United States
Clinical Trials Research ( Site 0115)
Sacramento, California, United States
Velocity Clinical Research, Banning ( Site 0017)
San Bernardino, California, United States
Emerson Clinical Research Institute ( Site 0118)
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials ( Site 0053)
Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0088)
Coral Gables, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0094)
Fort Myers, Florida, United States
...and 158 more locations
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).
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 will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \<70 mg/dL and ≥50% reduction from baseline.
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 will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline.
Time frame: Baseline and Week 24