Open-label Extension Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
NCT Number: NCT06492291
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hypercholesterolemia
Interventions: DRUG: Enlicitide Decanoate
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2028-10-13
Locations: Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048), Phoenix, Arizona, 85020, United States|Clinical Trials Research ( Site 0054), Sacramento, California, 95821, United States|Velocity Clinical Research, Banning ( Site 0023), San Bernardino, California, 92408, United States|Excel Medical Clinical Trials ( Site 0010), Boca Raton, Florida, 33434, United States|Alliance for Multispecialty Research, LLC ( Site 0056), Fort Myers, Florida, 33912, United States|Jacksonville Center for Clinical Research ( Site 0025), Jacksonville, Florida, 32216, United States|Progressive Medical Research ( Site 0033), Port Orange, Florida, 32127, United States|Clinical Research Trials of Florida ( Site 0006), Tampa, Florida, 33607, United States|East Coast Institute for Research, LLC ( Site 0020), Macon, Georgia, 31210, United States|Healthcare Research Network - Chicago ( Site 0051), Flossmoor, Illinois, 60422, United States|Midwest Institute For Clinical Research ( Site 0052), Indianapolis, Indiana, 46260, United States|Velocity Clinical Research Rockville ( Site 0022), Rockville, Maryland, 20854, United States|Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018), Troy, Michigan, 48098, United States|Velocity Clinical Research, Gulfport ( Site 0032), Gulfport, Mississippi, 39503, United States|Healthcare Research Network - St. Louis ( Site 0040), Hazelwood, Missouri, 63042, United States|Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0031), Lincoln, Nebraska, 68506, United States|Jubilee Clinical Research ( Site 0049), Las Vegas, Nevada, 89106, United States|New Mexico Clinical Research & Osteoporosis Center ( Site 0043), Albuquerque, New Mexico, 87106, United States|Lillestol Research ( Site 0030), Fargo, North Dakota, 58104, United States|altoona center for clinical research ( Site 0024), Duncansville, Pennsylvania, 16635, United States|Piedmont Research Partners ( Site 0045), Fort Mill, South Carolina, 29707, United States|Velocity Clinical Research, Greenville ( Site 0015), Greenville, South Carolina, 29615, United States|Holston Medical Group ( Site 0034), Kingsport, Tennessee, 37660, United States|Alliance for Multispecialty Research, LLC ( Site 0050), Knoxville, Tennessee, 37920, United States|Synexus Clinical Research US, Inc. ( Site 0003), Salt Lake City, Utah, 84106, United States|Velocity Clinical Research, Salt Lake City ( Site 0041), West Jordan, Utah, 84088, United States|Manassas Clinical Research Center ( Site 0007), Manassas, Virginia, 20110, United States|Health Research of Hampton Roads, Inc. ( Site 0019), Newport News, Virginia, 23606, United States|Alliance for Multispecialty Research, LLC ( Site 0008), Norfolk, Virginia, 23502, United States|National Clinical Research, Inc ( Site 0044), Richmond, Virginia, 23294, United States|Rainier Clinical Research Center ( Site 0013), Renton, Washington, 98057, United States|North York Diagnostic and Cardiac Centre ( Site 0505), North York, Ontario, M6B 3H7, Canada|Samsung Medical Center-cardiology ( Site 3000), Seoul, 06351, Korea, Republic of|Pacific Clinical Research Network - Rotorua ( Site 2902), Rotorua, Bay Of Plenty, 3010, New Zealand|Changhua Christian Hospital ( Site 3101), Changhua County, Changhua, 50006, Taiwan|National Cheng Kung University Hospital-Internal Medicine ( Site 3107), Tainan, 704, Taiwan|National Taiwan University Hospital ( Site 3100), Taipei, 10002, Taiwan|Taipei Veterans General Hospital ( Site 3106), Taipei, 112, Taiwan

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).

Primary Outcome Measures: 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., 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., Up to approximately 3 years
Secondary Outcome Measures: 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., 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., 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., Baseline of the parent study and Week 8 of this extension study|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., 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., 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., Baseline in the parent study and up to approximately 3 years in this extension study