> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-extension-study-of-enlicitide-decanoate-mk-0616-ef95c8e2-8a60-4c35-a329-bffd257ea451 > Record changed: 2026-10-13 # Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension NCT06492291 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) Participants 3,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) Start date 2024-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) Number of sites 222 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Short title** Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Official title** A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Dates **Completion date** 2028-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **First posted** 2024-07-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Registry last updated** 2025-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Primary completion date** 2028-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Start date** 2024-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Size and sites **Participants** 3,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Planned participants** 3,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Number of sites** 222 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Identifiers **Registry ID** NCT06492291 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **ClinicalTrials.gov ID** NCT06492291 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Outcomes ### Primary outcomes 1. Number of participants with one or more adverse events (AEs) Timeframe: Up to approximately 3 years 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. 2. Number of participants who discontinue study drug due to an AE Timeframe: Up to approximately 3 years 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. ### Secondary outcomes 1. Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study Timeframe: Baseline of the parent study and 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. 2. 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 Timeframe: Baseline of the parent study and 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. 3. Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study Timeframe: Baseline of the parent study and 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. 4. Percent change from baseline of the parent study in lipoprotein(a) (Lp\[a\]) at Week 8 of this extension study Timeframe: Baseline of the parent study and 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. 5. Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study Timeframe: Baseline in the parent study and up to approximately 3 years in this extension 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. 6. Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study Timeframe: Baseline in the parent study and up to approximately 3 years in this extension 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study) - Had an overall study intervention compliance ≥80% while participating in their parent study ### Exclusion criteria - Has discontinued study intervention in their parent study - Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study - Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study - Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Sites - Alliance for Multispecialty Research, LLC ( Site 0027)Daphne, United States - G&L Research ( Site 0035)Foley, United States - Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)Phoenix, United States - National Heart Institute-Research ( Site 0029)Beverly Hills, United States - Clinical Trials Research ( Site 0054)Sacramento, United States - Velocity Clinical Research, Banning ( Site 0023)San Bernardino, United States - Emerson Clinical Research Institute ( Site 0017)Washington D.C., United States - Excel Medical Clinical Trials ( Site 0010)Boca Raton, United States - Alliance for Multispecialty Research, LLC ( Site 0037)Doral, United States - Alliance for Multispecialty Research, LLC ( Site 0056)Fort Myers, United States - Velocity Clinical Research, Hallandale Beach ( Site 0053)Hallandale, United States - Jacksonville Center for Clinical Research ( Site 0025)Jacksonville, United States - South Broward Research ( Site 0012)Miramar, United States - Progressive Medical Research ( Site 0033)Port Orange, United States - Clinical Research Trials of Florida ( Site 0006)Tampa, United States - Clinical Site Partners, LLC dba Flourish Research ( Site 0004)Winter Park, United States - East Coast Institute for Research, LLC ( Site 0020)Macon, United States - Healthcare Research Network - Chicago ( Site 0051)Flossmoor, United States - Synexus Clinical Research US - Evansville ( Site 0005)Evansville, United States - Midwest Institute For Clinical Research ( Site 0052)Indianapolis, United States - Alliance for Multispecialty Research, LLC ( Site 0001)Lexington, United States - L-MARC Research Center ( Site 0011)Louisville, United States - Velocity Clinical Research, Covington ( Site 0026)Covington, United States - Velocity Clinical Research Rockville ( Site 0022)Rockville, United States - Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)Troy, United States And 197 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](http://www.merckclinicaltrials.com/) ### Other registry identifiers (5) - MK-0616-019 - 2023 - U1111-1290-3950 - jRCT2051240110 - 2023-504922-20-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06492291) ## Related records ### Drugs (1) - [Enlicitide decanoate](https://trialight.com/data/asset/enlicitide-decanoate-3671a2dd-56b6-4033-acf5-27fbb0102d79.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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