PEARL — Participatory Evaluation of Aging with Rapamycin

Design

PEARL was a Phase 4, decentralised, randomised, double-blind, placebo- controlled trial of weekly rapamycin in healthy adults aged 50–85, sponsored by AgelessRx with academic collaborators. Participants were randomised to placebo, 5 mg/week, or 10 mg/week of compounded rapamycin for ~48 weeks.

Endpoints included:

• visceral adiposity by DEXA;
• lean mass;
• physical-function tests;
• quality-of-life measures;
• a broad safety panel.

Why it matters

Most prior rapamycin human data came from transplant or oncology contexts at much higher continuous doses. PEARL was among the first trials to test the low, intermittent dosing schedules used in longevity-medicine practice under blinded, randomised conditions.

Findings (preliminary)

Reported in conference proceedings and pre-prints rather than full peer-reviewed manuscripts at the time of writing:

• Modest improvements in lean-mass preservation, particularly in women.
• Quality-of-life measures favoured the active arms.
• No serious safety signals at the doses tested over the trial duration.

Final published manuscript should be consulted for definitive results.

Limitations

Small sample, decentralised methodology, and reliance on patient-reported and home-collected measures limit interpretation. A trial of this size cannot rule out rare or longer-term harms.

Related entries

See also: Rapamycin, ITP, Matt Kaeberlein.