Ongoing Lung Decline With Age Intensified Response

NCT07676435 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-01

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-17
Primary Completion
2027-06-16
Completion
2027-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676435 on ClinicalTrials.gov