A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Public ClinicalTrials.gov record NCT05261126. 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 2b, 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 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 identification
- NCT ID
- NCT05261126
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 381 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Mar 9, 2022
- Primary completion
- Nov 27, 2022
- Completion
- Nov 27, 2022
- Last update posted
- Dec 8, 2024
2022
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Westside Medical Associates of Los Angeles ( Site 0026) | Beverly Hills | California | 90211 | — |
| Clinical Trials Research ( Site 0007) | Sacramento | California | 95821 | — |
| National Research Institute (NRI) - Santa Ana ( Site 0024) | Santa Ana | California | 92704 | — |
| Excel Medical Clinical Trials ( Site 0042) | Boca Raton | Florida | 33434 | — |
| Alliance for Multispecialty Research, LLC ( Site 0050) | Coral Gables | Florida | 33134 | — |
| ForCare Clinical Research ( Site 0017) | Tampa | Florida | 33613 | — |
| Healthcare Research Network - Chicago ( Site 0037) | Flossmoor | Illinois | 60422 | — |
| Midwest Institute For Clinical Research ( Site 0036) | Indianapolis | Indiana | 46260 | — |
| Cotton O'Neil Mulvane ( Site 0022) | Topeka | Kansas | 66606 | — |
| L-MARC Research Center ( Site 0003) | Louisville | Kentucky | 40213 | — |
| The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028) | Jackson | Mississippi | 39216 | — |
| Jubilee Clinical Research ( Site 0047) | Las Vegas | Nevada | 89106 | — |
| New Mexico Clinical Research & Osteoporosis Center ( Site 0032) | Albuquerque | New Mexico | 87106 | — |
| Mid Hudson Medical Research ( Site 0004) | New Windsor | New York | 12553 | — |
| altoona center for clinical research ( Site 0045) | Duncansville | Pennsylvania | 16635 | — |
| Piedmont Research Partners ( Site 0005) | Fort Mill | South Carolina | 29707 | — |
| Dallas Diabetes Research Center ( Site 0012) | Dallas | Texas | 75230 | — |
| Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051) | Houston | Texas | 77030 | — |
| Northeast Clinical Research of San Antonio ( Site 0014) | San Antonio | Texas | 78233 | — |
| National Clinical Research, Inc-research office ( Site 0019) | Richmond | Virginia | 23294 | — |
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 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05261126, 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 Dec 8, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05261126 live on ClinicalTrials.gov.