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New pill could melt away heart disease plaque, major trial underway

NCT ID NCT06305559

Disease control Sponsor: NewAmsterdam Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a daily pill (obicetrapib plus ezetimibe) to see if it can reduce fatty plaque buildup in the arteries of 300 adults with heart disease. Participants must already be on cholesterol-lowering therapy but still have high LDL cholesterol and measurable plaque. The trial uses CT scans to track plaque changes over 18 months, comparing the drug to a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Fasting serum LDL-C ≥70 mg/dL (≥1.81 mmol/L) * Evaluable non-calcified plaque of at least 75 mm3 in the major epicardial coronary arteries * BMI 18-40, inclusive * Max tolerated lipid modifying therapy * Estimated glomerular filtration rate ≥40 mL/min/1.73 m2 Exclusion Criteria: * HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening * Contraindications for CCTA * History of coronary artery bypass graft * Active liver disease

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease coronary artery disorder hyperlipidemia Plaque, Atherosclerotic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Lipidemia Plaque, atherosclerotic

Contacts and locations

Locations

  • NGMR

    Hialeah, Florida, 33016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.