Alirocumab Trial Posts Plaque-Volume Results After Transplant

ClinicalTrials.gov posted results on 2026-08-18 for a completed phase 2 trial of alirocumab early after heart transplantation. The study enrolled 114 participants with vasculopathy and compared alirocumab with placebo, reporting plaque-volume, LDL-C, and apolipoprotein B measurements.

Background

The study evaluated alirocumab, described in the record as a PCSK9 inhibitor, when administered early after heart transplantation. Its stated focus was the safety and efficacy of alirocumab and its impact on cardiac allograft vasculopathy, a form of vasculopathy affecting the transplanted heart. The trial compared alirocumab with placebo.

Trial design

This was a completed phase 2 study listed under the condition vasculopathy. It enrolled 114 participants and included alirocumab and placebo intervention groups. The record’s stated main objective was to assess safety and impact on cardiac allograft vasculopathy when alirocumab was given early after heart transplantation. No primary outcome measures were listed in the supplied record.

Key results

For plaque volume, the posted mean was 176.3 mm³ with a standard deviation of 95.2 mm³ in the alirocumab group, compared with 173.7 mm³ and a standard deviation of 96.7 mm³ with placebo. A second posted plaque-volume measurement listed means of 184.5 mm³ and 183.1 mm³ for alirocumab and placebo, respectively; the corresponding standard deviations were 105.4 mm³ and 109.8 mm³.

LDL-C means were reported as 72.7 mg/dL for alirocumab and 69.0 mg/dL for placebo, with standard deviations of 31.7 mg/dL and 22.4 mg/dL. Another LDL-C measurement listed means of 31.5 mg/dL and 69.2 mg/dL, with standard deviations of 20.7 mg/dL and 28.1 mg/dL. ApoB means were also posted: 73.8 mg/dL versus 68.2 mg/dL, and 39.6 mg/dL versus 70.1 mg/dL, for alirocumab and placebo, respectively.

What this means

The record provides several group-level measurements but no p-values, confidence intervals, primary outcome results, or adverse-event summary. The plaque-volume means were similar between groups in the listed measurements, while the reported LDL-C and ApoB values varied across the posted measurements. These data alone do not establish comparative efficacy or safety.

Source

This article is based on results posted by ClinicalTrials.gov on 2026-08-18. The source document is the ClinicalTrials.gov study record, available at clinicaltrials.gov.