Loading
Fisetin-dose 1 / Fisetin-dose 2 / Organ Failure · Phase 2 Trial
ClinicalTrials.gov · September 1, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active Phase 2 adaptive allocation trial testing two doses of the senolytic fisetin versus placebo in sepsis, with no results yet reported. The study is designed to identify the most efficacious dose and estimate the probability of Phase 3 success; the primary outcome is change in composite cardiovascular, respiratory, and renal SOFA score at day 7.
Phase 2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Sepsis, Acute Infection, Organ Failure; age from 65 Years. Intervention: Fisetin- dose 1; Fisetin- dose 2. Compared with: Placebo — Placebo Comparator. n = 220. 10 sites: United States.
This is an active Phase 2 adaptive allocation trial testing two doses of the senolytic fisetin versus placebo in sepsis, with no results yet reported. The study is designed to identify the most efficacious dose and estimate the probability of Phase 3 success; the primary outcome is change in composite cardiovascular, respiratory, and renal SOFA score at day 7.
Primary outcome is a composite organ dysfunction score, not a hard clinical endpoint such as mortality or length of stay
Clinicians should not interpret this registry record as evidence of benefit; it describes an ongoing trial designed to test whether fisetin reduces organ dysfunction in sepsis and to determine optimal dosing for a subsequent Phase 3 trial. Results are not yet available.
This is a Phase 2 adaptive allocation trial in active recruitment with no results posted; it is designed to identify an efficacious dose and predict Phase 3 success, not to establish clinical benefit.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should not interpret this registry record as evidence of benefit; it describes an ongoing trial designed to test whether fisetin reduces organ dysfunction in sepsis and to determine optimal dosing for a subsequent Phase 3 trial. Results are not yet available.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05758246). This is a study registration, not published results. Lead sponsor: University of Minnesota. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 220 participants (ESTIMATED). Conditions: Sepsis, Acute Infection, Organ Failure. Interventions: DRUG: Fisetin-dose 1; DRUG: Fisetin-dose 2; DRUG: Placebo. Primary outcome measures: Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA) , day 7. Brief summary: The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway. A multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.