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NCT05469347: PALMS
Alirocumab in Patients with Sepsis
Phase 1 trial testing Alirocumab in Sepsis in 50 participants. Completed in 23 February 2025.
18 February 2025
Quick facts
| Lead sponsor | Jonathan Sevransky |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 4 January 2023 |
| Primary completion | 18 February 2025 |
| Estimated completion | 23 February 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Alirocumab (ALIROCUMAB) — full drug profile →
- Placebo
Conditions studied
- Sepsis — all drugs for Sepsis →
Sponsor
Jonathan Sevransky
Who can join
Adults 18 to 90, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine whether the drug alirocumab, which may lower cholesterol, can reduce the amount of inflammation caused by an infection that has caused either low blood pressure or difficulty breathing. Participants will be randomized to receive a single IV infusion of alirocumab or a placebo.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
From geroscience to precision geromedicine: Understanding and managing aging.
Kroemer G, Maier AB, Cuervo AM, Gladyshev VN, et al · · 2025 · cited 139× · PMID 40250404 · DOI 10.1016/j.cell.2025.03.011 -
Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside.
Bao X, Liang Y, Chang H, Cai T, et al · · 2024 · cited 101× · PMID 38185721 · DOI 10.1038/s41392-023-01690-3 -
The evolving landscape of PCSK9 inhibition in cancer.
Oza PP, Kashfi K. · · 2023 · cited 32× · PMID 37059376 · DOI 10.1016/j.ejphar.2023.175721 -
Dysregulation of Neutrophil-Endothelial Communication in Sepsis: Mechanisms and Therapeutic Perspectives.
Esmalian Afyouni N, Kiani MF, Kilpatrick LE. · · 2026 · PMID 41972674 · DOI 10.3390/cells15070581
Verify or expand the search:
- PubMed search for NCT05469347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alirocumab
Trials testing the same drug.
- NCT07477704 — A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemi · Phase 2 · not yet recruiting
- NCT06858332 — Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia · recruiting
- NCT06385262 — TOP 2301: Neoadjuvant Chemo for NSCLC · Phase 2 · suspended
- NCT06080256 — Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS) · Phase 3 · unknown
- NCT06083961 — The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis · Phase 4 · not yet recruiting
Other recruiting trials for Sepsis
Currently open trials in the same condition.
- NCT07507877 — Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness · recruiting
- NCT07154615 — Assessing Immune Dysfunction in Sepsis · recruiting
- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07351344 — African Survey on Sepsis Knowledge (ASK) · recruiting
- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · 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 NCT05469347 (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 Jonathan Sevransky
- Last refreshed: 24 March 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/NCT05469347.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing