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NCT06048302
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
Phase 1 trial testing Obicetrapib in Hepatic Impairment in 18 participants. Completed in 19 March 2024.
12 March 2024
Quick facts
| Lead sponsor | NewAmsterdam Pharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 18 |
| Start date | 30 November 2023 |
| Primary completion | 12 March 2024 |
| Estimated completion | 19 March 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Obicetrapib — full drug profile →
Conditions studied
- Hepatic Impairment — all drugs for Hepatic Impairment →
- Healthy — all drugs for Healthy →
Sponsor
NewAmsterdam Pharma — full company profile →
Who can join
Adults 18 to 75, any sex, with Hepatic Impairment or Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Existing and Potential Therapeutic Strategies for Lowering Lipoprotein(a) Levels: An Update.
Domański I, Kozieł A, Domański J, Trocha M. · · 2026 · PMID 41899103 · DOI 10.3390/jcm15062179
Verify or expand the search:
- PubMed search for NCT06048302
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Obicetrapib
Trials testing the same drug.
- NCT06250205 — Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib · Phase 1 · completed
- NCT05972278 — Investigating the Effect of Obicetrapib on Lipoprotein Metabolism · Phase 1 · active not recruiting
- NCT06081166 — A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin · Phase 1 · completed
- NCT05425745 — Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies. · Phase 3 · completed
- NCT05421078 — A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy. · Phase 2 · completed
Other recruiting trials for Hepatic Impairment
Currently open trials in the same condition.
- NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
- NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
- NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting
Other NewAmsterdam Pharma trials
Trials by the same sponsor.
- NCT06547359 — A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects · Phase 1 · completed
- NCT06005597 — Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies · Phase 3 · completed
- NCT06250205 — Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib · Phase 1 · completed
- NCT06050291 — Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe · Phase 1 · completed
- NCT05972278 — Investigating the Effect of Obicetrapib on Lipoprotein Metabolism · Phase 1 · active not 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 NCT06048302 (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 NewAmsterdam Pharma
- Last refreshed: 19 September 2024
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/NCT06048302.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing