NCT04488601: PEARL

Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study

Completed Phase 2 Last updated 24 January 2024

What this trial tests

Phase 2 trial testing Rapamycin in Aging in 129 participants. Completed in 30 December 2023.

Timeline

1 January 2020

Primary endpoint
30 December 2023

30 December 2023

Quick facts

Lead sponsor	AgelessRx
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	129
Start date	1 January 2020
Primary completion	30 December 2023
Estimated completion	30 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Rapamycin — full drug profile →
• Placebo

Conditions studied

• Aging — all drugs for Aging →

Sponsor

AgelessRx — full company profile →

Who can join

Adults 50 to 85, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, placebo-controlled trial into the safety and efficacy in reducing clinical measures of aging in an older adult population.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigenetic regulation of aging: implications for interventions of aging and diseases.
   Wang K, Liu H, Hu Q, Wang L, et al · · 2022 · cited 406× · PMID 36336680 · DOI 10.1038/s41392-022-01211-8
2. Microglial phagocytosis dysfunction in stroke is driven by energy depletion and induction of autophagy.
   Beccari S, Sierra-Torre V, Valero J, Pereira-Iglesias M, et al · · 2023 · cited 59× · PMID 36622892 · DOI 10.1080/15548627.2023.2165313
3. Human age reversal: Fact or fiction?
   Johnson AA, English BW, Shokhirev MN, Sinclair DA, et al · · 2022 · cited 56× · PMID 35778957 · DOI 10.1111/acel.13664
4. A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults.
   Huang H. · · 2022 · cited 38× · PMID 35821806 · DOI 10.3389/fragi.2022.851698
5. Blazing a trail for the clinical use of rapamycin as a geroprotecTOR.
   Konopka AR, Lamming DW, RAP PAC Investigators, EVERLAST Investigators. · · 2023 · cited 33× · PMID 37801202 · DOI 10.1007/s11357-023-00935-x
6. A comprehensive AI-driven analysis of large-scale omic datasets reveals novel dual-purpose targets for the treatment of cancer and aging.
   Pun FW, Leung GHD, Leung HW, Rice J, et al · · 2023 · cited 21× · PMID 37888486 · DOI 10.1111/acel.14017
7. Chronic HIV Infection and Aging: Application of a Geroscience-Guided Approach.
   Masters MC, Landay AL, Robbins PD, Tchkonia T, et al · · 2022 · cited 21× · PMID 35015744 · DOI 10.1097/qai.0000000000002858
8. Influence of rapamycin on safety and healthspan metrics after one year: PEARL trial results.
   Moel M, Harinath G, Lee V, Nyquist A, et al · · 2025 · cited 17× · PMID 40188830 · DOI 10.18632/aging.206235