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New pill combo aims to slash cholesterol in High-Risk patients

NCT ID NCT07219602

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This Phase 3 study tests whether a daily pill combining obicetrapib and ezetimibe, or obicetrapib alone, can lower LDL (bad) cholesterol more than placebo in 300 people with type 2 diabetes or metabolic syndrome. Participants continue their standard cholesterol medications. The main goal is to measure cholesterol changes after 84 days.

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 (fixed-dose combination or obicetrapib alone)
What this could lead to
If successful, this could provide a new daily pill option to better control cholesterol in people with diabetes or metabolic syndrome, reducing heart disease risk.
What could go wrong
This is a Phase 3 trial, but results may not apply to everyone. Side effects or lack of significant benefit over existing treatments are possible.

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

Dec 2025

Expected to finish

Jun 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

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: * fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L) * Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \<400 mg/dL (\<4.5 mmol/L) * Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \<400 mg/dL (\<4.5 mmol/L) and at least 2 risk factors * Are on stable guideline-recommended lipid-lowering therapy * Estimated glomerular filtration rate ≥15 mL/min/1.73 m2 Exclusion Criteria: * Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30% * Have been hospitalized for heart failure within 5 years prior to Screening * Have uncontrolled severe hypertension * Have a formal diagnosis of homozygous familial hypercholesterolemia * HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening * active liver disease

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome hyperlipidemia metabolic syndrome X type 2 diabetes mellitus

As listed by the trial registrant

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

Lipidemia Metabolic syndrome (METS) Type 2 diabetes (T2DM)

Contacts and locations

Locations

  • Albert Schweitzer Ziekenhuis

    Zwijndrecht, South Holland, 3331LZ, Netherlands

  • Baylor College of Medicine - Center for Cardiometabolic Disease Prevention (The Center for Cardiovascular Disease Prevention)

    Houston, Texas, 77030, United States

  • Bethesda Diabetes Research Center

    Hoogeveen, Drenthe, 7909AA, Netherlands

  • Burke Internal Medicine

    Burke, Virginia, 22015-2234, United States

  • Burke International Medicine DBA Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Cardiovascular Center of Sarasote Foundation for Research and Education

    Sarasota, Florida, 34239-3513, United States

  • Central New York Clinical Research

    Manlius, New York, 13104, United States

  • Centricity Research dba Lucas Research

    Morehead City, North Carolina, 28557, United States

  • Clinical Research Institute of Arizona

    Sun City West, Arizona, 85375, United States

  • Clinical Trials of Texas dba Flourish Research

    San Antonio, Texas, 78229, United States

  • DIA-GNOSIS, s.r.o.

    Piešťany, Trnava Region, 92101, Slovakia

  • DOCTOR MN s.r.o

    Čáslav, 286 01, Czechia

  • Deventer Ziekenhuis

    Deventer, Overijssel, 7416SE, Netherlands

  • Diabetes & Glandular Disease Clinic, P.A.

    Kingsport, Tennessee, 37660, United States

  • Diabetologie - Dr. Tomas Edelsberger

    Krnov, 79401, Czechia

  • Dieko s.r.o

    Pilsen, 30100, Czechia

  • Dien Servis s.r.o.

    Humpolec, Vysocina, 39601, Czechia

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • East Coast Institute of Research LLC

    Jacksonville, Florida, 32216, United States

  • East Coast Institute of Research LLC

    Lake City, Florida, 32055, United States

  • Eastern Maine Medical Center

    Bangor, Maine, 04401, United States

  • Endeavour Health

    Skokie, Illinois, 60077, United States

  • Fakultni Nemocnice (FN) v Motole (Motol University Hospital)

    Prague, 15006, Czechia

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Funkystuff s.r.o.

    Nové Zámky, Nitra Region, 940 02, Slovakia

  • High Desert Heart

    Meridian, Idaho, 83642, United States

  • Human-Care, s.r.o.

    Košice, Košice Region, 4001, Slovakia

  • Inspira Health - Internal Medicine Associates

    Bridgeton, New Jersey, 08302, United States

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21, Czechia

  • Interni diabetologicka ambulance (Pratia)

    Jílové u Prahy, 252 42, Czechia

  • JAL s.r.o.

    Trnava, Trnava Region, 917 01, Slovakia

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109, United States

  • Juno Research LLC - Medical Center

    Houston, Texas, 77054, United States

  • K2 Medical Research

    Maitland, Florida, 32751, United States

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213, United States

  • MD Medical Research

    Oxon Hill, Maryland, 20745, United States

  • MEDIKA Hradec Králové, s.r.o.

    Hradec Králové, 50002, Czechia

  • MUDr. Alena Váchová

    České Budějovice, 370 11, Czechia

  • MUDr. Žáková s.r.o.

    Trenčín, Trenčín Region, 91101, Slovakia

  • Montana Medical Research

    Missoula, Montana, 59808, United States

  • Nemocnice Na Františku

    Prague, 11 000, Czechia

  • Nemocnicna a.s

    Malacky, 901 01, Slovakia

  • Noordwest Ziekenhuisgroep - Alkmaar

    Alkmaar, North Holland, 1815JD, Netherlands

  • Pavol Jozef Šafárik University

    Košice, Košice Region, 4022, Slovakia

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina, 27408, United States

  • PlanIt Research, PLLC

    Houston, Texas, 77079, United States

  • Pratia Pardubice a.s. (Pratia)

    Pardubice, 53002, Czechia

  • Rijnstate Ziekenhuis

    Arnhem, Gelderland, 6815AD, Netherlands

  • Scripps Health - Whittier Diabetes Institute

    La Jolla, California, 92037, United States

  • Summit Research Group

    Munroe Falls, Ohio, 44262, United States

  • UC SanDiego Health

    La Jolla, California, 92037, United States

  • UF Health Jackson

    Jacksonville, Florida, 32209, United States

  • Universal Research Group

    Tacoma, Washington, 98405, United States

  • Velocity Clinical Research

    Durham, North Carolina, 27710, United States

  • Western University of Health Sciences

    Pomona, California, 91766, United States

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