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New daily pill aims to crush stubborn cholesterol in High-Risk patients

NCT ID NCT06005597

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a daily pill combining two drugs, obicetrapib and ezetimibe, in 407 people with inherited high cholesterol or heart disease. Participants took the combination or a placebo on top of their usual cholesterol meds. The main goal was to see if the combo lowered LDL ('bad') cholesterol more than placebo or either drug alone. Results are pending.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
obicetrapib and ezetimibe combination pill
What this could lead to
If successful, this combination pill could offer a new, more effective daily option to lower LDL cholesterol in people with stubborn high cholesterol, potentially reducing heart attack and stroke risk.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The combination may cause side effects or not work better than existing treatments. Long-term safety and heart benefits are still unknown.

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

407 people

The number who actually took part.

Started

Mar 2024

Finished

Oct 2024

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

18 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: * Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors * On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications * LDL-C ≥ 70 mg/dL * Triglycerides \< 500 * Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2 Exclusion Criteria: * History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction \<30% * Hospitalized for heart failure within the last 5 years * Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months * Uncontrolled severe hypertension * Diagnosis of homozygous FH * Liver disease * HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL * Thyroid-stimulating hormone \>1.5 x upper limit of normal (ULN) * History of malignancy * Creatinine kinase (CK) \>3 X ULN * Alcohol abuse * Treatment with investigational product * Treatment with gemfibrozil or ezetimibe * Previous participation in a trial evaluating obicetrapib * Known allergy to study drugs, placebo or excipients in study drugs of placebo * Other condition that would interfere with the conduct of the study

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease Dyslipidemias familial hypercholesterolemia Hypercholesterolemia hyperlipidemia Hyperlipoproteinemia Type II inherited lipid metabolism disorder

As listed by the trial registrant

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

ASCVD Dyslipidemias Familial hypercholesterolemia High cholesterol Hypercholesterolemia

Contacts and locations

Locations

  • Alpine Research Organization, Inc.

    Clinton, Utah, 84015, United States

  • Amarillo Heart Clinical Research Institute, Inc

    Amarillo, Texas, 79124, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Capital Area Research

    Camp Hill, Pennsylvania, 17074, United States

  • Cardiovascular Research of Knoxville

    Powell, Tennessee, 37849, United States

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, Indiana, 46321, United States

  • Cary Research Group, LLC

    Cary, North Carolina, 27518, United States

  • Center for Advanced Research and Education

    Gainesville, Georgia, 30501, United States

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303, United States

  • Centricity Research - Columbus

    Columbus, Georgia, 31904, United States

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee, 37404, United States

  • DM Clinical Research

    Houston, Texas, 77375, United States

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132, United States

  • East Valley Diabetes & Endocrinology

    Gilbert, Arizona, 85297, United States

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077, United States

  • Grace Research, LLC - Bossier City, LA

    Bossier City, Louisiana, 71111, United States

  • Hampton Roads Center for Clinical Research

    Suffolk, Virginia, 23435, United States

  • Horizon Research Group of Opelousas

    Eunice, Louisiana, 70535, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Juno Research, LLC - Medical Center Office

    Houston, Texas, 77054, United States

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557, United States

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229, United States

  • McClaren Bay Heart and Vascular

    Bay City, Michigan, 49770, United States

  • Metabolic and Atherosclerosis Research Center

    Cincinnati, Ohio, 45227, United States

  • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc

    Rapid City, South Dakota, 57701, United States

  • NSC Research

    Johns Creek, Georgia, 30024, United States

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Northern Pines Health Center

    Buckley, Michigan, 49620, United States

  • Northwest Houston Heart Center

    Tomball, Texas, 77375, United States

  • Novant Health Clinical Research, LLC

    Charlotte, North Carolina, 27701, United States

  • Novant Health Heart and Vascular Institute

    Charlotte, North Carolina, 28204, United States

  • Oakland Medical Research Center

    Troy, Michigan, 48085, United States

  • PharmaTex Research, LLC

    Amarillo, Texas, 79109, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404, United States

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • Spectrum Medical, Inc.

    Danville, Virginia, 24541, United States

  • St. Louis Heart and Vascular Cardiology

    St Louis, Missouri, 63136, United States

  • Summit Research Group, LLC

    Stow, Ohio, 44240, United States

  • TidalHealth Peninsula Regional, Inc.

    Salisbury, Maryland, 21804, United States

  • Triad Internal Medicine

    Asheboro, North Carolina, 27203, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63136, United States

  • Wellness Clinical Research Associates

    McKinney, Texas, 75069, United States

  • Wilmington Health Associates

    Wilmington, North Carolina, 28412, United States

More trials for these conditions

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