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NCT06592482
A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
Phase 1 trial testing AZD0780 in Renal Impairment in 30 participants. Completed in 1 December 2024.
1 December 2024
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 2 August 2024 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- AZD0780 — full drug profile →
Conditions studied
- Renal Impairment — all drugs for Renal Impairment →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 85, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase I, multi-centre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 in male and female participants (females of non-childbearing potential) with severe renal impairment not on dialysis, end-stage renal disease (ESRD) on intermittent haemodialysis (HD), or moderate renal impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal renal function. Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention. Eligible participants will be admitted to the study site on Day -1. On Day 1, an "A" single oral dose of AZD0780 will be administered, and participants will be confined to the study site until after assessments are completed on Day 11.
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 NCT06592482
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD0780
Trials testing the same drug.
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- NCT07218900 — A Study to Investigate the Effect of AZD0780 Tablets in Combination With Rosuvastatin Tablets on Low Density Lipoprotein · Phase 2 · recruiting
- NCT07216131 — A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Yea · Phase 1 · completed
- NCT07000136 — A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH · Phase 3 · active not recruiting
- NCT07000357 — A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a · Phase 3 · recruiting
Other recruiting trials for Renal Impairment
Currently open trials in the same condition.
- NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
- NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
- NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
- NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
- NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
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- NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
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- NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
- NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · 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 NCT06592482 (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 AstraZeneca
- Last refreshed: 20 February 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/NCT06592482.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing