The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
381
Enclitide Chloride administered orally
Placebo matching enclitide chloride administered orally
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported.
Time frame: Baseline and up to Week 8
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one AE was reported.
Time frame: Up to approximately 17 Weeks
Percentage of Participants Who Discontinued Study Intervention Due to AEs
An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to AEs was reported.
Time frame: Up to approximately 9 Weeks
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in ApoB at week 8 was reported.
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Westside Medical Associates of Los Angeles ( Site 0026)
Beverly Hills, California, United States
Clinical Trials Research ( Site 0007)
Sacramento, California, United States
National Research Institute (NRI) - Santa Ana ( Site 0024)
Santa Ana, California, United States
Excel Medical Clinical Trials ( Site 0042)
Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0050)
Coral Gables, Florida, United States
ForCare Clinical Research ( Site 0017)
Tampa, Florida, United States
Healthcare Research Network - Chicago ( Site 0037)
Flossmoor, Illinois, United States
Midwest Institute For Clinical Research ( Site 0036)
Indianapolis, Indiana, United States
Cotton O'Neil Mulvane ( Site 0022)
Topeka, Kansas, United States
L-MARC Research Center ( Site 0003)
Louisville, Kentucky, United States
...and 53 more locations
Time frame: Baseline and up to Week 8
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8
Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in non-HDL-C at week 8 was reported.
Time frame: Baseline and up to Week 8
Percentage of Participants With LDL-C Value at Goal at Week 8
LDL-C goal was defined as: LDL-C \<70 mg/dL (\<1.81 mmol/L) in participants with clinical atherosclerotic cardiovascular disease (ASCVD), LDL-C \<100 mg/dL (\<2.59 mmol/L) in participants with an ASCVD risk-equivalent and/or a 10-year risk of having an ASCVD event that is ≥7.5%, OR LDL-C \<130 mg/dL (\<3.37mmol/L) in participants with a 10-year risk of having an ASCVD event that is ≥5.0% and \<7.5%. The percentage of participants with LDL-C value at goal at week 8 were reported.
Time frame: Week 8