A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
Public ClinicalTrials.gov record NCT05952856. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05952856
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,912 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 10, 2023 (Actual)
- Primary completion
- Jul 28, 2025 (Actual)
- Completion
- Jul 28, 2025 (Actual)
- Last update posted
- Sep 24, 2026
2023 – 2025
United States locations
- U.S. sites
- 49
- U.S. states
- 25
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC ( Site 0093) | Daphne | Alabama | 36526 | — |
| G&L Research ( Site 0043) | Foley | Alabama | 36535 | — |
| Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084) | Phoenix | Arizona | 85020 | — |
| National Heart Institute-Research ( Site 0087) | Beverly Hills | California | 90211 | — |
| Clinical Trials Research ( Site 0115) | Sacramento | California | 95821 | — |
| Velocity Clinical Research, Banning ( Site 0017) | San Bernardino | California | 92408 | — |
| Emerson Clinical Research Institute ( Site 0118) | Washington D.C. | District of Columbia | 20009 | — |
| Excel Medical Clinical Trials ( Site 0053) | Boca Raton | Florida | 33434 | — |
| Alliance for Multispecialty Research, LLC ( Site 0088) | Coral Gables | Florida | 33134 | — |
| Alliance for Multispecialty Research, LLC ( Site 0094) | Fort Myers | Florida | 33912 | — |
| Velocity Clinical Research, Hallandale Beach ( Site 0018) | Hallandale | Florida | 33009 | — |
| Jacksonville Center for Clinical Research ( Site 0049) | Jacksonville | Florida | 32216 | — |
| South Broward Research ( Site 0051) | Miramar | Florida | 33027 | — |
| Clinical Research Trials of Florida ( Site 0063) | Tampa | Florida | 33607 | — |
| East Coast Institute for Research, LLC ( Site 0033) | Macon | Georgia | 31210 | — |
| Healthcare Research Network - Chicago ( Site 0052) | Flossmoor | Illinois | 60422 | — |
| Synexus Clinical Research US, Inc. ( Site 0109) | Evansville | Indiana | 47714 | — |
| Midwest Institute For Clinical Research ( Site 0059) | Indianapolis | Indiana | 46260 | — |
| Alliance for Multispecialty Research, LLC ( Site 0028) | Lexington | Kentucky | 40509 | — |
| L-MARC Research Center ( Site 0001) | Louisville | Kentucky | 40213 | — |
| Velocity Clinical Research, Covington ( Site 0068) | Covington | Louisiana | 70433 | — |
| Velocity Clinical Research Rockville ( Site 0082) | Rockville | Maryland | 20854 | — |
| Velocity Clinical Research, Gulfport ( Site 0039) | Gulfport | Mississippi | 39503 | — |
| Healthcare Research Network - St. Louis ( Site 0054) | Hazelwood | Missouri | 63042 | — |
| Jubilee Clinical Research ( Site 0106) | Las Vegas | Nevada | 89106 | — |
| AB Clinical Trials ( Site 0070) | Las Vegas | Nevada | 89119 | — |
| New Mexico Clinical Research & Osteoporosis Center ( Site 0005) | Albuquerque | New Mexico | 87106 | — |
| Velocity Clinical Research, Syracuse ( Site 0021) | East Syracuse | New York | 13057 | — |
| Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002) | New York | New York | 10029 | — |
| Lillestol Research ( Site 0026) | Fargo | North Dakota | 58104 | — |
| altoona center for clinical research ( Site 0089) | Duncansville | Pennsylvania | 16635 | — |
| Cardiology Consultants of Philadelphia Yardley ( Site 0097) | Yardley | Pennsylvania | 19067 | — |
| Piedmont Research Partners ( Site 0090) | Fort Mill | South Carolina | 29707 | — |
| Velocity Clinical Research, Greenville ( Site 0023) | Greenville | South Carolina | 29615 | — |
| Coastal Carolina Research Center ( Site 0006) | North Charleston | South Carolina | 29405 | — |
| Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009) | Rapid City | South Dakota | 57701 | — |
| Holston Medical Group ( Site 0048) | Kingsport | Tennessee | 37660 | — |
| Alliance for Multispecialty Research, LLC ( Site 0008) | Knoxville | Tennessee | 37920 | — |
| Velocity Clinical Research, Dallas ( Site 0114) | Dallas | Texas | 75230 | — |
| Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111) | Houston | Texas | 77030 | — |
| Clinical Trials of Texas, LLC ( Site 0103) | San Antonio | Texas | 78229 | — |
| Synexus Clinical Research US, Inc. ( Site 0110) | Salt Lake City | Utah | 84106 | — |
| Velocity Clinical Research, Salt Lake City ( Site 0019) | West Jordan | Utah | 84088 | — |
| Manassas Clinical Research Center ( Site 0007) | Manassas | Virginia | 20110 | — |
| Health Research of Hampton Roads, Inc. ( Site 0044) | Newport News | Virginia | 23606 | — |
| Alliance for Multispecialty Research, LLC ( Site 0101) | Norfolk | Virginia | 23502 | — |
| National Clinical Research, Inc ( Site 0061) | Richmond | Virginia | 23294 | — |
| Centricity Research Suffolk Family Medicine ( Site 0092) | Suffolk | Virginia | 23435 | — |
| Rainier Clinical Research Center ( Site 0116) | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 119 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05952856, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05952856 live on ClinicalTrials.gov.