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RECRUITING Phase 2 ClinicalTrials.gov

Ongoing Lung Decline With Age Intensified Response

Sponsor: Cedars-Sinai Medical Center • ClinicalTrials.gov ID: NCT07676435

Registry updated: 2026-10-15
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Description

This Phase II, randomized, double-blind, placebo-controlled pilot study will evaluate the effects of fisetin, a senolytic flavonoid compound, on lung function and biomarkers of cellular senescence in older adults aged 60 years and older. Participants will include individuals with a history of at least 10 pack-years of smoking as well as age-matched never-smokers. Forty participants will be randomized to receive either fisetin or placebo using a short-course "hit-and-run" dosing strategy (approximately 20 mg/kg/day orally for 2 consecutive days on Days 1-2 and Days 8-9).

Interventions

  • Fisetin (Drug)
    Participants randomized to the experimental arm will receive oral fisetin capsules administered at a target dose of approximately 20 mg/kg/day for 2 consecutive days on Days 1-2 and again on Days 8-9. Fisetin will be supplied as 100 mg capsules and dosed according to body weight using a senolytic "hit-and-run" treatment approach.
  • Placebo (Drug)
    Participants randomized to the control arm will receive matching placebo capsules administered orally on the same schedule as the fisetin arm (Days 1-2 and Days 8-9). Placebo will be used to maintain blinding and permit comparison of efficacy and safety outcomes between treatment groups.

Eligibility criteria

Inclusion Criteria: * Adults aged 60 years and older who are physically capable of participating in study procedures; * Willing to be randomized to fisetin or placebo; weight stable within the previous 2 months (\<5-pound change); * No blood donation within 2 months before screening; absence of unstable chronic disease; * Willing to maintain baseline activity level throughout the study; * Body mass index \<30 kg/m²; * Either a history of at least 10 pack-years of cigarette smoking or never-smoking status. Exclusion Criteria: * Electrocardiogram (ECG) abnormalities, including prolonged QTc. * Use of fisetin, other flavonoid supplements, or known senolytic compounds within 6 months prior to screening. * Resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>110 mmHg. * Known allergy or hypersensitivity to fisetin or any component of the study product. * Active malignancy, except non-melanoma skin cancer. * Clinically significant hepatic, renal, cardiovascular, endocrine, immunologic, metabolic, or other uncontrolled medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results. * Clinically significant laboratory abnormalities, including severe anemia, leukopenia, thrombocytopenia, uncontrolled diabetes, advanced kidney disease, significant liver dysfunction, or evidence of systemic inflammation. * Human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, or invasive fungal infection. * History of diverticulitis or diverticulosis with gastrointestinal bleeding. * Current use of systemic corticosteroids. * Current use of warfarin. * Current use of medications with significant interaction potential with fisetin, including selected CYP450 or transporter substrates, inhibitors, or inducers, unless such medications can be safely withheld according to protocol requirements. * Recent medication, supplement, or lifestyle changes that may affect study outcomes, in the opinion of the investigator. * Inability to perform required study procedures, including pulmonary function testing, exercise testing, or other protocol assessments. * Unwillingness or inability to provide informed consent. * Pregnancy or breastfeeding. * Any other condition that, in the opinion of the investigator, would make participation unsafe or compromise study integrity.

Conditions

Age-Related Lung Function Decline

Locations

  • Cedars-Sinai Medical Center — Los Angeles, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record