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New pill could help lower stubborn high cholesterol

NCT ID NCT05142722

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tested a new drug called obicetrapib in over 2,500 people with high cholesterol that wasn't well controlled by their current treatments. Participants took either a 10 mg obicetrapib pill or a placebo daily for about 6 months. The main goal was to see if obicetrapib could lower LDL (bad) cholesterol more than placebo.

What this could mean

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

Active substance
obicetrapib
What this could lead to
If successful, obicetrapib could offer a new daily pill to help lower stubborn high cholesterol when statins aren't enough.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not work better than placebo or could have side effects not yet known.

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

2,530 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 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: * Females may be enrolled if all 3 of the following criteria are met: * They are not pregnant; * They are not breastfeeding; and * They do not plan on becoming pregnant during the study; * Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD * Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows: * A statin at a maximally tolerated stable dose for at least 8 weeks prior to Screening * Atorvastatin 40 and 80 mg; and * Rosuvastatin 20 and 40 mg; * Ezetimibe with or without maximally tolerated statin for at least 8 weeks prior to Screening * Bempedoic acid with a maximally tolerated statin for at least 8 weeks prior to Screening * A PCSK-9 targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening * Have a fasting serum LDL-C at Screening as follows: * Fasting serum LDL-C ≥ 55 to \< 100 mg/dL (≥1.4 to \<2.6 mmol/L) OR non-HDL-C ≥85 mg/dL (≥2.2 mmol/L) to \< 130 mg/dL (\<3.4 mmol/L) with at least 1 of the following risk enhancers at Screening; * Recent MI (\> 3 and \< 12 months prior to Randomization); * Type 2 diabetes mellitus; * Current daily cigarette smoking; * Age of \> 60 years; * High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L (≥19.0 nmol/L) at Screening or within 6 months prior to Screening * Fasting triglycerides (TG) \> 150 mg/dL (\>1.7 mmol/L); * Fasting lipoprotein (a) \> 30 mg/dL (\>70 nmol/L); and/or * Fasting HDL-C \< 40 mg/dL (\<1.0 mmol/L); OR * Fasting serum LDL-C ≥ 100 mg/dL (≥2.6 mmol/L) or non-HDL-C ≥130 mg/dL (≥3.4 mmol/L) * Fasting triglyceride (TG) \< 500 mg/dL (\<5.7 mmol/L) at Screening; and * Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at Screening Exclusion Criteria: * New York Heart Association class III or IV heart failure or left ventricular ejection fraction \< 30%; * Hospitalized for heart failure within 5 years prior to Screening * Major adverse cardiac event (MACE) within 3 months prior to Screening; * Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization; * Formal diagnosis of homozygous familial hypercholesterolemia (HoFH); * Active liver disease; * HbA1c ≥10% or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening; * Thyroid-stimulating hormone \>1.5 X upper limit of normal (ULN) at Screening; * Creatine kinase \> 3 X upper limit of normal (ULN) at Screening; * History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization; * Known history of alcohol and/or drug abuse within 5 years prior to Randomization * Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer; * Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening * Planned use of other investigational products or devices during the course of the study; * Participated in any clinical trial evaluating obicetrapib; or * Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo * Any condition that, according to the Investigator, could 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.

Atherosclerotic cardiovascular disease Dyslipidemias Familial hypercholesterolemia High cholesterol Hypercholesterolemia

Contacts and locations

Locations

  • 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu

    Wroclaw, 50-981, Poland

  • AB Clinical Trials

    Las Vegas, Nevada, 89119, United States

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Acad. G. Chapidze Emergency Cardiology Center LTD

    Tbilisi, 0159, Georgia

  • Academic Medical Center - Department of Vascular Medicine

    Amsterdam, 1105 AZ, Netherlands

  • Adapti LTD

    Tbilisi, 0186, Georgia

  • Advanced Research Institute Inc

    New Port Richey, Florida, 34653, United States

  • Affiliated Hospital of Chifeng University

    Chifeng, 24050, China

  • Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia

    Ruda Śląska, 41-710, Poland

  • Albert Schweitzer Ziekenhuis - Location Dordrecht

    Zwijndrecht, 3331 LZ, Netherlands

  • Alta Pharmaceutical Research Center

    Peachtree Corners, Georgia, 30092, United States

  • Amager Hospital

    Copenhagen S, 2300, Denmark

  • Amarillo Heart Clinical Research Institute, Inc

    Amarillo, Texas, 79106, United States

  • American Institute of Research

    Beverly Hills, California, 90211, United States

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401, United States

  • Arcturus Healthcare, Troy Internal Medicine Research Division

    Troy, Michigan, 48098, United States

  • Biofortis, Inc

    Addison, Illinois, 60101, United States

  • Bokhua Memorial Cardiovascular Center LTD

    Tbilisi, 0159, Georgia

  • Bravis ziekenhuis - Locatie Roosendaal

    Roosendaal, 4708 AE, Netherlands

  • CCR Czech a.s.

    Pardubice, 530 02, Czechia

  • CCR Ostrava s.r.o.

    Ostrava, 702 00, Czechia

  • CENTRUM MEDYCZNE INTERCOR Sp. z o.o.

    Bydgoszcz, 85-605, Poland

  • Cambridge Medical Trials

    Alexandria, Louisiana, 71301, United States

  • Cangzhou Central Hospital

    Cangzhou, 61017, China

  • Canisius-Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, 6532 SZ, Netherlands

  • Cardiovascular Research of Knoxville, LLC

    Powell, Tennessee, 37849, United States

  • Central Alabama Research

    Birmingham, Alabama, 35209, United States

  • Centricity Research

    Columbus, Georgia, 31904, United States

  • Centrum Medyczne Kermed - Renata Bijata-Bronisz I Ewa Kowalinska Spólka Jawna

    Bydgoszcz, 85-231, Poland

  • Centrum pro zdravi - kardiologie s.r.o.

    Brno, 603 00, Czechia

  • Cevni ambulance - MATMED s.r.o.

    Hodonín, 695 01, Czechia

  • Chear Center LLC

    The Bronx, New York, 10455, United States

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Chifeng Municipal Hospital

    Chifeng, 24099, China

  • China-Japan Union Hospital Of Jilin University

    Changchun, 130033, China

  • ClinCloud LLC

    Maitland, Florida, 32751, United States

  • Clinical Best Solutions - Lublin

    Lublin, 20-078, Poland

  • Clinical Best Solutions Sp. z.o.o Spolka Komandytowa

    Warsaw, 00-710, Poland

  • Clinical Research Institute of Arizona, LLC

    Sun City West, Arizona, 85375, United States

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125, United States

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606, United States

  • Daqing People's Hospital

    Daqing, 163711, China

  • Diabetes and Endocrinology Consultants, P.C.

    Morehead City, North Carolina, 28557, United States

  • East Coast Institute for Research

    Saint Augustine, Florida, 32086, United States

  • East Coast Institute for Research - Canton

    Canton, Georgia, 30114, United States

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32204, United States

  • East Coast Institute for Research, LLC

    Macon, Georgia, 31210, United States

  • East Coast Institute for Research, LLC - Jacksonville University Blvd

    Jacksonville, Florida, 32216, United States

  • East Coast Institute for Research- Lake City

    Lake City, Florida, 32055, United States

  • Eclipse Clinical Research

    Tucson, Arizona, 85745, United States

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077, United States

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434, United States

  • Foshan First People's Hospital

    Foshan, 528010, China

  • FutureMeds Lodz

    Lodz, 91-363, Poland

  • FutureMeds Sp. z o.o

    Wroclaw, 50-088, Poland

  • FutureMeds Targowek

    Warsaw, 03-291, Poland

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215, Poland

  • Futuremeds Olsztyn

    Olsztyn, 10-010, Poland

  • Gelre Ziekenhuizen - Locatie Zutphen

    Zutphen, 7207 AE, Netherlands

  • Georgian-Ducht Hospital LTD

    Tbilisi, 0172, Georgia

  • Godstrup Regional Hospital (Gødstrup)

    Herning, 7400, Denmark

  • Grace Research, LLC

    Bossier City, Louisiana, 71111, United States

  • Grace Research, LLC

    Shreveport, Louisiana, 71105, United States

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • Hampton Roads Center for Clinical Research

    Suffolk, Virginia, 23434, United States

  • Health LTD

    Batumi, 6004, Georgia

  • Hebei Petro China Central Hospital

    Langfang, 65099, China

  • Heilongjiang Provincial Hospital

    Harbin, 150036, China

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530, Japan

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hornicka nemocnice s poliklinikou Bilina s.r.o.

    Bílina, 418 01, Czechia

  • Huabei Petroleum Administration Bureau General Hospital

    Renqiu, 62550, China

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Hyōgo, 670-8560, Japan

  • IJsselland ziekenhuis

    Capelle aan den IJssel, 2906 ZC, Netherlands

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN, Netherlands

  • Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus

    Lodz, 94-255, Poland

  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman

    Gdynia, 81-157, Poland

  • Inquest Clinical Research

    Baytown, Texas, 77521, United States

  • Inspira Medical Centers dba Internal Medicine Associates, P.A.

    Bridgeton, New Jersey, 08302, United States

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Ishikawa Prefectural Central Hospital

    Ishikawa, 920-8530, Japan

  • JSC Curatio

    Tbilisi, 0114, Georgia

  • Japan Community Health Care Organization Kyushu Hospital

    Fukuoka, 806-8501, Japan

  • Javara Inc.

    Conroe, Texas, 77384, United States

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ, Netherlands

  • Jinan Central Hospital

    Jinan, 250013, China

  • KARDIOLOGIE - LIBEREC s.r.o.

    Liberec, 46014, Czechia

  • KO - MED Centra Kliniczne Lublin II

    Lublin, 20-362, Poland

  • Kardiologicka ambulance Brno s.r.o.

    Brno, 612 00, Czechia

  • Kardiologie COR s.r.o.

    Prague, 106 00, Czechia

  • Kendall South Medical Center, Inc.

    Miami, Florida, 33185, United States

  • Kokura Memorial Hospital

    Kitakyushu, 802-8555, Japan

  • Komatsu Municipal Hospital

    Ishikawa, 923-8560, Japan

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501, Poland

  • Laurentius Hospital Roermond

    Roermond, 6043 CV, Netherlands

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104, United States

  • Lishui Central Hospital

    Lishui, 323020, China

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

    Louisville, Kentucky, 40213, United States

  • Luoyang Third People's Hospital

    Luoyang, 471002, China

  • MUDr. Tomas Edelsberger - diabetologicka ambulance

    Krnov, 794 01, Czechia

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Martini Ziekenhuis

    Groningen, 9728 NT, Netherlands

  • Medi Club Georgia LLC

    Tbilisi, 0160, Georgia

  • Medicus Services SRO

    Brandýs nad Labem, 250 01, Czechia

  • Mid Hudson Medical Research

    New Windsor, New York, 12553, United States

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260, United States

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701, United States

  • NZOZ Twoje Zdrowie EL Sp. z o.o.

    Elblag, 82-300, Poland

  • National Cerebral and Cardiovascular Center Research Institute

    Osaka, 565-8565, Japan

  • New Generation of Medical Research

    Hialeah, Florida, 33016, United States

  • New Tokyo Heart Clinic

    Chiba, 271-0077, Japan

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8510, Japan

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD, Netherlands

  • Northern Light Cardiology

    Bangor, Maine, 04401, United States

  • Northwest Houston Clinical Research

    Tomball, Texas, 77375, United States

  • Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna

    Staszów, 28-200, Poland

  • Oakland Medical Research

    Troy, Michigan, 48085, United States

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC, Netherlands

  • Orange County Research Center

    Tustin, California, 92780, United States

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, 569-8686, Japan

  • Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Panjin Liaoyou Gem Flower Hospital

    Panjin, 124010, China

  • Peking University First Hospital

    Beijing, 100034, China

  • Pinnacle Research Group

    Anniston, Alabama, 36207, United States

  • Pioneer Clinical Studies

    Ft. Pierce, Florida, 34950, United States

  • PreventaMed s.r.o.

    Olomouc, 779 00, Czechia

  • Prime Revival Research Institute, LLC

    Coppell, Texas, 75019, United States

  • Privia Medical Group, LLC

    Silver Spring, Maryland, 20901, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Prywatny Gabinet Lekarski Jacek Gessek

    Torun, 87-100, Poland

  • Public Central Hospital of Matto lshikawa

    Ishikawa, 924-8588, Japan

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD, Netherlands

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303, United States

  • Sakurabashi Watanabe Hospital

    Osaka, 530-0001, Japan

  • Showa University Northern Yokohama Hospital

    Kanagawa, 224-8503, Japan

  • Silmedic Sp. z o.o.

    Katowice, 40-282, Poland

  • Slingeland Ziekenhuis

    Doetinchem, 7009 BL, Netherlands

  • SouthCoast Health

    Savannah, Georgia, 31406, United States

  • Southern Clinical Research, LLC

    Zachary, Louisiana, 70791, United States

  • St. Jansdal Ziekenhuis

    Harderwijk, 3844 DG, Netherlands

  • Summit Research Group, LLC

    Stow, Ohio, 44224, United States

  • Sydvestjysk Hospital

    Esbjerg, 6700, Denmark

  • Syed Research Consultants, LLC

    Sheffield, Alabama, 35660, United States

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083, United States

  • Synexus Clinical Research US, Inc.

    The Villages, Florida, 32162, United States

  • Synexus Clinical Research US, Inc.

    Atlanta, Georgia, 30328, United States

  • Synexus Clinical Research US, Inc.

    Evansville, Indiana, 47714, United States

  • Synexus Clinical Research US, Inc.

    New York, New York, 10017, United States

  • Synexus Clinical Research US, Inc.

    Salt Lake City, Utah, 84106, United States

  • Synexus Clinical Research US, Inc. / Orange Grove Family Practice

    Tucson, Arizona, 85741, United States

  • Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PC

    Birmingham, Alabama, 35211, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • Tandem Clinical Research GI - Metairie

    Metairie, Louisiana, 70006, United States

  • Tandem Clinical Research GI, LLC

    New York, New York, 10033, United States

  • Tergooiziekenhuizen Blaricum

    Blaricum, 1261 AN, Netherlands

  • The Center for Clinical Trials, Inc

    Saraland, Alabama, 36571, United States

  • The First Affiliated Hospital Of University Of South China

    Hunan, 421001, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233017, China

  • The First Medical Center LTD

    Tbilisi, 0180, Georgia

  • The First People's Hospital of Changde City

    Changde, 415003, China

  • The First affiliated Hospital of Nanyang Medical College

    Nanyang, 473024, China

  • The Sakakibara Heart Institute of Okayama

    Okayama, 700-0804, Japan

  • The Second People's Hospital of Changzhou

    Changzhou, 213164, China

  • The Third Affiliated Hospital of Guangzhou Medical university

    Guangzhou, 510150, China

  • The Third Affiliatied Hospital of Xinxiang Medical University

    Xinxiang, 453000, China

  • Thyroid, Endocrinology & Diabetes, PA

    Dallas, Texas, 75208, United States

  • Tianjin Fourth Central Hospital

    Tianjin, 300143, China

  • Tianjin People's Hospital

    Tianjin, 300121, China

  • Tokyo Saiseikai Central Hospital

    Tokyo, 108-0073, Japan

  • Universal Research Group, LLC

    Tacoma, Washington, 98405, United States

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • Viborg Regional Hospital

    Viborg, 8800, Denmark

  • VieCuri Medisch Centrum

    Venlo, 5912 BL, Netherlands

  • Vitamedi LTD

    Tbilisi, 0159, Georgia

  • Wenzhou People's Hospital

    Wenzhou, 325099, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xi'an Gaoxin Hospital

    Xi'an, 710075, China

  • Xianyang Hospital of Yan 'an University

    Xianyang, 712099, China

  • Zaozhuang Municipal Hospital

    Zaozhuang, 277102, China

  • Ziekenhuis Deventer

    Deventer, 7416 SE, Netherlands

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD, Netherlands

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