Recruiting
Phase 2

Fisetin

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT07676435

Conditions

Age-Related Lung Function Decline

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Fisetin

Placebo

Study Details

Brief summary:

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).

Conditions

Age-Related Lung Function Decline

Study ID

NCT07676435

Start date

Jun 17, 2026

Status verified date

Jun, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Jun 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fisetin

Participants receive oral fisetin at approximately 20 mg/kg/day for 2 consecutive days on Days 1-2 and again on Days 8-9 using a senolytic "hit-and-run" dosing strategy.

placebo comparator: Placebo

Participants receive matching placebo capsules administered on the same schedule as the fisetin arm (Days 1-2 and Days 8-9).

Interventions

Fisetin

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

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.

Primary outcome measure

  • Forced Vital Capacity (FVC) [ Time Frame: Baseline and Day 14 ]
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline and Day 14 ]
  • FEV1/FVC Ratio [ Time Frame: Baseline and Day 14 ]

Central Contacts and Locations

Central contacts

Samuel Cohen, MD

310-423-1725samuel.cohen@csmc.edu

Yunhee Choi-Kuaea

Yunhee.Choi-Kuaea@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Yunhee Choi-Kuaea

yunhee.choi-kuaea@cshs.org

Principal Investigator:

Samuel Cohen, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Aging
  • Cellular Senescence
  • Healthy Aging
  • Smoking-Related Lung Function Decline
  • Pulmonary Function
  • Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-07-01.