Enlicitide Decanoate Clinical Trials (2026): 28 Studies for Healthy & Hypercholesterolemia
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
28 Enlicitide Decanoate clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 8 indications (including Healthy & Hypercholesterolemia) and 22,873 total planned enrollment. 6 Phase 3 Enlicitide Decanoate trials are listed. 2 Enlicitide Decanoate clinical trials are actively recruiting at 7 U.S. sites across 7 states. Most recent activity: NCT07058077 (Jan 2037).
Where to Participate: All Enlicitide Decanoate Trial Sites in the U.S. (7 sites across 7 states)
Every actively recruiting Enlicitide Decanoatetrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AZ | Celerion ( Site 0001) | Tempe85283 | NCT07300280 | Map |
| DE | Nemours/Alfred I. duPont Hospital for Children ( Site 0001) | Wilmington19803 | NCT07058077 | Map |
| DC | Children's National Medical Center ( Site 0015) | Washington D.C.20010 | NCT07058077 | Map |
| FL | Excel Medical Clinical Trials ( Site 0008) | Boca Raton33434 | NCT07058077 | Map |
| GA | Children's Healthcare of Atlanta Cardiology ( Site 0026) | Atlanta30329 | NCT07058077 | Map |
| OH | Cincinnati Children's Hospital Medical Center ( Site 0016) | Cincinnati45229 | NCT07058077 | Map |
| WV | West Virginia University ( Site 0013) | Morgantown26506 | NCT07058077 | Map |
Enlicitide Decanoate clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | Total |
|---|---|---|---|---|
| P1 | 1 | 20 | 21 | |
| P2/P3 | 1 | 1 | ||
| P3 | 3 | 3 | 6 |
Recruiting Enlicitide Decanoate clinical trials (2)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07058077 | MK-0616-029A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) | P2/P3 | Heterozygous Familial Hypercholesterolemia (HeFH) | 153 | Aug 2025 |
| NCT07300280 | MK-0616-039A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) | P1 | Healthy | 60 | Dec 2025 |
Enlicitide Decanoate clinical trials by indication
Healthy (18)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07300280 | MK-0616-039 | P1 | recruiting | A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) |
| NCT07481708 | MK-0616 | P1 | completed | A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041) |
| NCT07044479 | MK-0616-040 | P1 | completed | A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040) |
| NCT06643377 | MK-0616-032 | P1 | completed | A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032) |
| NCT06880874 | MK-0616 | P1 | completed | A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035) |
| NCT06719544 | MK-0616-034 | P1 | completed | A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034) |
| NCT06609512 | MK-0616-033 | P1 | completed | A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033) |
| NCT06597760 | MK-0616-031 | P1 | completed | A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) |
| + 10 more, see All trials below. | ||||
Hypercholesterolemia (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06492291 | MK-0616-019 | P3 | active not recruiting | Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension |
| NCT05952856 | MK-0616-013 | P3 | completed | A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids |
| NCT05952869 | — | P3 | completed | A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH) |
| NCT06450366 | — | P3 | completed | A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) |
Hyperlipidemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07216482 | MK-0616-037 | P3 | active not recruiting | A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) |
Heterozygous Familial Hypercholesterolemia (HeFH) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07058077 | MK-0616-029 | P2/P3 | recruiting | A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) |
Hepatic Insufficiency (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06575959 | MK-0616-030 | P1 | completed | A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030) |
Arteriosclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06008756 | MK-0616-015 | P3 | active not recruiting | Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes |
Hypercholesterolaemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05934292 | MK-0616-020 | P1 | completed | Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020) |
Moderate Renal Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05070390 | MK-0616-007 | P1 | completed | A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007) |
Enlicitide Decanoate pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| MK-0616-015 | NCT06008756 | P3 | active not recruiting | Arteriosclerosis | 14,550 | — |
| MK-0616-019 | NCT06492291 | P3 | active not recruiting | Hypercholesterolemia | 3,000 | — |
| MK-0616-037 | NCT07216482 | P3 | active not recruiting | Hyperlipidemia | 975 | — |
| MK-0616-013 | NCT05952856 | P3 | completed | Hypercholesterolemia | 2,912 | PMID 41879224 |
All Enlicitide Decanoate trials (28)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07058077 | MK-0616-029 | A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) | P2/P3 | recruiting | 153 | Merck Sharp & Dohme LLC | Aug 2025 |
| NCT06008756 | MK-0616-015 | Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes | P3 | active not recruiting | 14,550 | Merck Sharp & Dohme LLC | Oct 2023 |
| NCT06492291 | MK-0616-019 | Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension | P3 | active not recruiting | 3,000 | Merck Sharp & Dohme LLC | Aug 2024 |
| NCT07216482 | MK-0616-037 | A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) | P3 | active not recruiting | 975 | Merck Sharp & Dohme LLC | Nov 2025 |
| NCT07300280 | MK-0616-039 | A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) | P1 | recruiting | 60 | Merck Sharp & Dohme LLC | Dec 2025 |
| NCT07481708 | MK-0616 | A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041) | P1 | completed | 30 | Merck Sharp & Dohme LLC | Mar 2026 |
| NCT07044479 | MK-0616-040 | A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040) | P1 | completed | 60 | Merck Sharp & Dohme LLC | Jul 2025 |
| NCT05952856 | MK-0616-013 | A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids | P3 | completed | 2,912 | Merck Sharp & Dohme LLC | Aug 2023 |
| NCT06643377 | MK-0616-032 | A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032) | P1 | completed | 27 | Merck Sharp & Dohme LLC | Nov 2024 |
| NCT06880874 | MK-0616 | A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035) | P1 | completed | 40 | Merck Sharp & Dohme LLC | Apr 2025 |
| NCT06575959 | MK-0616-030 | A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030) | P1 | completed | 20 | Merck Sharp & Dohme LLC | Sep 2024 |
| NCT05952869 | A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH) | P3 | completed | 303 | Merck Sharp & Dohme LLC | Aug 2023 | |
| NCT06450366 | A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) | P3 | completed | 301 | Merck Sharp & Dohme LLC | Jul 2024 | |
| NCT06719544 | MK-0616-034 | A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034) | P1 | completed | 16 | Merck Sharp & Dohme LLC | Jan 2025 |
| NCT06609512 | MK-0616-033 | A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033) | P1 | completed | 20 | Merck Sharp & Dohme LLC | Oct 2024 |
| NCT06597760 | MK-0616-031 | A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031) | P1 | completed | 24 | Merck Sharp & Dohme LLC | Oct 2024 |
| NCT06625814 | MK-0616 | A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028) | P1 | completed | 28 | Merck Sharp & Dohme LLC | Jul 2024 |
| NCT06772792 | MK-0616 | A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027) | P1 | completed | 36 | Merck Sharp & Dohme LLC | Apr 2024 |
| NCT06772779 | MK-0616 | A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026) | P1 | completed | 36 | Merck Sharp & Dohme LLC | Apr 2024 |
| NCT06699329 | MK-0616 | A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023) | P1 | completed | 38 | Merck Sharp & Dohme LLC | Jan 2024 |
| NCT06691906 | MK-0616 | A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025) | P1 | completed | 40 | Merck Sharp & Dohme LLC | Mar 2024 |
| NCT05934292 | MK-0616-020 | Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020) | P1 | completed | 33 | Merck Sharp & Dohme LLC | Jul 2023 |
| NCT06655311 | MK-0616 | A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012) | P1 | completed | 56 | Merck Sharp & Dohme LLC | Sep 2022 |
| NCT06699355 | MK-0616 | A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024) | P1 | completed | 18 | Merck Sharp & Dohme LLC | Nov 2023 |
| NCT06658652 | MK-0616 | The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022) | P1 | completed | 34 | Merck Sharp & Dohme LLC | Oct 2023 |
| NCT06658626 | MK-0616-016 | A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016) | P1 | completed | 8 | Merck Sharp & Dohme LLC | Mar 2023 |
| NCT06814106 | MK-0616 | A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010) | P1 | completed | 37 | Merck Sharp & Dohme LLC | Mar 2023 |
| NCT05070390 | MK-0616-007 | A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007) | P1 | completed | 18 | Merck Sharp & Dohme LLC | Nov 2021 |
Enlicitide Decanoate clinical trials: frequently asked questions
- How many Enlicitide Decanoate clinical trials are there?
- 28 Enlicitide Decanoate clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 2 are actively recruiting participants. 23 are marked completed.
- Are Enlicitide Decanoate clinical trials recruiting in 2026?
- Yes — 2 Enlicitide Decanoate trials are actively recruiting in 2026, with 7 U.S. sites across 7 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Enlicitide Decanoate being studied for?
- Enlicitide Decanoate is being studied for Healthy, Hypercholesterolemia, Familial Hypercholesterolemia, Hypercholesterolaemia, Hyperlipidemia and 6 more. The trials are grouped by indication on this page.
- What phase is Enlicitide Decanoate in?
- Enlicitide Decanoate clinical trials span 6 Phase 3, 21 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Enlicitide Decanoate clinical trials?
- The lead sponsor across the most Enlicitide Decanoate trials is Merck Sharp & Dohme LLC. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Enlicitide Decanoateas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: