SAMSON-2

Clinical trial
N-of-1
Statins
Nationwide randomized trial testing a digital double-blind N-of-1 platform against standard care for statin intolerance. Sponsor and principal investigator.

Role: Sponsor and principal investigator
Design: Multicenter randomized controlled trial across 11 Danish cardiology lipid clinics
Status: Approved in CTIS (2025-524955-30-01), protocol paper submitted October 2026
Funding: Capital Region of Denmark, Bispebjerg Hospital research fund, Hørslev-Fonden

Many patients stop statins because of muscle symptoms, but blinded trials show that most of those symptoms also appear on placebo. SAMSON-2 asks whether a patient’s own blinded comparison changes that. Participants in the N-of-1 arm go through six blinded 28-day blocks, three on rosuvastatin 20 mg and three on identical placebo, separated by 14-day washouts. They record symptoms daily in an app and receive their personal result at the end. The control arm gets guideline-directed titration by the lipid clinic. The primary question is whether the N-of-1 result leads to more patients on a statin one year later.

The trial builds on the UK SAMSON trial by Howard, Francis and colleagues (2020). Darrel P. Francis (Imperial College London) and Luke Pilling (University of Exeter) collaborate on design and genetics.

Trial flow. 160 participants are randomised 1:1. The N-of-1 arm alternates rosuvastatin and placebo in six four-week blocks and sees its own result at week 36; the control arm gets standard titration. The primary endpoint is read at month 15.

Trial flow. 160 participants are randomised 1:1. The N-of-1 arm alternates rosuvastatin and placebo in six four-week blocks and sees its own result at week 36; the control arm gets standard titration. The primary endpoint is read at month 15.