Lp(a)FRONTIERS EXPANSION enrols 422 Black and Hispanic patients for a pelacarsen trial, ahead of schedule (Am J Prev Cardiol 2026)

Original title: Enhancing representation in cardiovascular trials: Lessons from Lp(a)FRONTIERS EXPANSION in United States Black and Hispanic patients with elevated lipoprotein(a) and established atherosclerotic cardiovascular disease

Am J Prev Cardiol · 10 February 2026 · 7

Ferdinand KC, Rodriguez F, Amraotkar AR, Venkataraman S, Ayaz I, Antequera O, Cao H, Zhu W, Wang J, Shapiro MD

Design and baseline report of Lp(a)FRONTIERS EXPANSION (NCT06267560), a phase 3b randomised, double-blind, placebo-controlled trial of pelacarsen (80 mg monthly subcutaneous injection) in US Black/African American and/or Hispanic individuals with Lp(a) 125 nmol/L or more and established ASCVD, describing strategies used to improve minority enrolment and retention. 422 patients were randomised 2:1 to pelacarsen or placebo across 103 sites in 21 US states/territories, completing enrolment a year ahead of schedule; 64 had completed the trial at the 7 October 2025 data cut-off. Mean age was 63.2±9.1 years, 50.7% male, 68.0% Black/African American, with median Lp(a) 110.3 mg/dL (226.6 nmol/L). The authors conclude culturally tailored design and operational strategies can improve minority participation in cardiovascular trials, with efficacy and safety results from the trial still pending.

Original abstract

Background: Black and Hispanic individuals are disproportionately impacted by elevated levels of lipoprotein(a) [Lp(a)] and atherosclerotic cardiovascular disease (ASCVD). Despite this, these populations are underrepresented in cardiovascular clinical trials. Herein, the strategies aimed to improve minority representation during the study design and recruitment phase of the Lp(a)FRONTIERS EXPANSION trial are described. Baseline characteristics and study attrition to date are also presented.

Methods: Lp(a)FRONTIERS EXPANSION (NCT06267560) is a randomized, double-blind, phase 3b, placebo-controlled trial evaluating pelacarsen in United States (US) Black/African American and/or Hispanic individuals with elevated Lp(a) (≥125 nmol/L) and established ASCVD. Eligible individuals were randomized 2:1 to receive monthly subcutaneous injections of either pelacarsen 80 mg or placebo, for 12 months. Various design and operational strategies were employed to improve enrollment and retention under four key themes: study design, site selection and engagement, enrollment support, and barrier removal.

Results: Overall, 422 patients were randomized to receive pelacarsen or placebo, with enrollment completed 1 year ahead of schedule. Patients were randomized from 103 sites across 21 US states/territories (including Puerto Rico); 8 sites recruited ≥10 patients. At data cut-off (7 October 2025), 64 patients had completed the trial. The mean±standard deviation age was 63.2 ± 9.1 years, 50.7% (214/422) of patients were male, and 68.0% (287/422) identified as Black/African American. Median (Q1, Q3) Lp(a) levels were 110.3 (79.4, 143.7) mg/dL (226.6 [165.8, 299.7] nmol/L).

Conclusion: The Lp(a)FRONTIERS EXPANSION trial suggests that deliberate, culturally tailored design and operational strategies may improve cardiovascular trial participation by US minority populations. Results from Lp(a)FRONTIERS EXPANSION will provide critical insights into the efficacy and safety profile of pelacarsen in treating elevated Lp(a).

Summary written by lp-a.org from the published abstract; figures as published. Page updated 17 August 2026. Methods.