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NCT06575959
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Phase 1 trial testing Enlicitide in Hepatic Insufficiency in 20 participants. Completed in 8 May 2025.
1 May 2025
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 20 September 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 8 May 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Enlicitide — full drug profile →
Conditions studied
- Hepatic Insufficiency — all drugs for Hepatic Insufficiency →
- Hepatic Impairment — all drugs for Hepatic Impairment →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
Adults 18 to 75, any sex, with Hepatic Insufficiency or Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health. This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
New frontiers in the treatment of hypercholesterolaemia: oral inhibition of PCSK9.
Arnaboldi L, Tang Z, Ferri N, Corsini A. · · 2026 · PMID 42099491 · DOI 10.1093/eurheartjsupp/suag035
Verify or expand the search:
- PubMed search for NCT06575959
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Enlicitide
Trials testing the same drug.
- NCT07481708 — A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041) · Phase 1 · active not recruiting
- NCT07300280 — A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) · Phase 1 · active not recruiting
- NCT07216482 — A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) · Phase 3 · recruiting
- NCT07044479 — A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040) · Phase 1 · completed
- NCT06880874 — A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035) · Phase 1 · completed
Other recruiting trials for Hepatic Insufficiency
Currently open trials in the same condition.
- NCT06957756 — A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
- NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
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- NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
- NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
- NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06575959 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 28 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06575959.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing