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NCT06643377
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
Phase 1 trial testing Enlicitide in Healthy in 27 participants. Completed in 25 June 2025.
25 June 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 | 27 |
| Start date | 22 November 2024 |
| Primary completion | 25 June 2025 |
| Estimated completion | 25 June 2025 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Enlicitide — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
- Renal Impairment — all drugs for Renal Impairment →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
Adults 18 to 85, any sex, with Healthy or Renal 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 (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06643377
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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
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Currently open trials in the same condition.
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Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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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 NCT06643377 (US National Library of Medicine, public domain)
- 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: 23 July 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/NCT06643377.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing