Actively Recruiting

Phase 1
Phase 2
Age: 20Years +
All Genders
Healthy Volunteers
NCT06431932

Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity

Led by Ove Andersen · Updated on 2026-03-27

60

Participants Needed

1

Research Sites

427 weeks

Total Duration

On this page

Sponsors

O

Ove Andersen

Lead Sponsor

U

University of Southern Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in animal models. We will conduct a clinical trial in healthy volunteers and older patients with multiple chronic diseases. The participants will receive fisetin or placebo for two days, after which they will be examined at regular intervals for up to three months. We will investigate how fisetin is absorbed and metabolized by the body, and whether fisetin is safe. We will also identify methods to best measure the effect of fisetin on chronic inflammation, senescent cells, and general health.

CONDITIONS

Official Title

Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteers aged 20 to 35 years
  • suPAR levels below 3.5 ng/mL (± 15% assay variation)
  • Ability to cooperate cognitively
  • Ability to read and understand Danish
  • Women of childbearing potential must use effective contraception
  • Older patients aged 65 years or older
  • Acutely hospitalized medical patients
  • suPAR levels above 5 ng/mL (± 15% assay variation) at screening
  • Multimorbidity with two or more chronic diagnoses
  • Ability to cooperate cognitively
  • Ability to read and understand Danish
  • suPAR levels above 5 ng/mL (± 15% assay variation) at 28 days after hospital discharge
Not Eligible

You will not qualify if you...

  • Body weight over 100 kg
  • Inability to swallow pills
  • Pregnancy or lactation
  • Known allergy or hypersensitivity to fisetin or placebo ingredients
  • Any condition that may pose a risk or prevent successful trial completion as judged by the investigator
  • Known chronic diagnosis (for healthy volunteers)
  • Active acute illness
  • Use of prescribed medications except contraceptives (for healthy volunteers)
  • Previous cancer diagnosis or treatment (for healthy volunteers)
  • Use of senolytic or other "anti-aging" supplements
  • Known HIV infection, active hepatitis B or C, or invasive fungal infection (older patients)
  • Uncontrolled pleural or pericardial effusions or ascites
  • New or active invasive cancer except non-melanoma skin cancers
  • Active cancer treatment or disseminated cancer
  • Major immunodeficiency conditions
  • CRP levels above 30 mg/L at 28 days after discharge (older patients)
  • Unstable major disorders such as cardiovascular, renal, endocrine, immunological, hepatic disease, or cancer
  • Estimated glomerular filtration rate below 15 ml/min/1.73 m2 or judged at risk of acute kidney injury
  • Use of strong CYP3A4 inhibitors or inducers, or medications with narrow therapeutic ranges affecting CYP3A4, CYP2D6, CYP2C9, or CYP2C8 enzymes
  • Use of specific drug classes or medications as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre

Hvidovre, Denmark, 2650

Actively Recruiting

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Research Team

J

Juliette Tavenier

CONTACT

L

Line Jee Hartmann Rasmussen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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