Amgen Advances Olpasiran Heart Plaque Study, Highlighting a Growing Bet on Lipoprotein(a)

Amgen Inc (AMGN) announced an update on their ongoing clinical study.

Study Overview

Amgen is launching a Phase 3 trial called “A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a).” The study will test whether lowering a blood fat marker called lipoprotein(a) with olpasiran can reduce soft plaque in heart arteries, a key driver of heart attacks and strokes. This update matters because it advances a new class of drugs aimed at a high-risk patient group that is not well served by current cholesterol medicines.

Intervention/Treatment

The trial is testing olpasiran, an injectable drug given under the skin every 12 weeks, against a placebo. Olpasiran is designed to reduce levels of lipoprotein(a), which is linked to clogged arteries and heart disease. The goal is to see if this targeted lowering of lipoprotein(a) can shrink non-calcified plaque in coronary arteries and improve long-term heart health.

Study Design

This is an interventional, randomized study, meaning participants are assigned by chance to receive either olpasiran or a placebo. It uses a parallel design, so each participant stays in their assigned group throughout the trial. The study is double-blind, so neither the patients nor the doctors know who is getting the active drug, which helps avoid bias. The main goal is treatment-focused: to see if olpasiran is safe and can reduce plaque burden compared with placebo.

Study Timeline

The study was first submitted on December 17, 2025, marking the formal start of the trial’s regulatory and site activation process. The same date, December 17, 2025, is also listed as the most recent update, signaling a fresh protocol and the transition toward site start-up and enrollment. Primary completion and final completion dates are not yet posted, but investors should assume a typical multi-year Phase 3 timeline from first patient in to headline data, suggesting that key efficacy readouts will likely land several years after recruitment begins.

Market Implications

For Amgen (AMGN), this study reinforces its strategy to build a strong position in cardiovascular medicine beyond traditional cholesterol drugs. Clear, positive data showing plaque reduction would support premium pricing, expand the treatable population, and deepen the company’s moat in high-risk cardiovascular patients. The update that the trial is moving into the Phase 3 setting should support long-term growth expectations and may be viewed positively by investors who focus on pipeline durability rather than near-term earnings. However, the lack of results and the early status of the trial mean little immediate revenue impact, and the stock reaction may be muted until key milestones such as first patient dosed or interim data are announced. Competitors in the lipoprotein(a) space, including other large-cap biopharma players developing similar injectable agents, face rising pressure as Amgen advances its program, increasing the chance of future market share battles and potential pricing competition. For now, the update mainly reduces development risk on execution and shows Amgen’s continued commitment to this high-value segment.

The study is currently in the start-up phase and remains active in planning, with further details and ongoing updates available on the ClinicalTrials.gov portal under the listed identifier.

To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.