AzTrials
AzTrials

DyslipidemiasPhase 3BROADWAYNCT05142722

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

A Phase 3 study testing Obicetrapib in people with Dyslipidemias and High Cholesterol, run by NewAmsterdam Pharma at 181 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Obicetrapib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,530 participants
Where
181 sitesin 8 countries
Study dates
15 Dec 2021to 26 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 25Show fewer
  • 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

Who cannot join

  • 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;
Show all 17Show fewer
  • 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

Trial locations and contacts

181 sites in 8 countries.

181 sites in 8 countries

United States69 sites

  • Biofortis, Inc

    Addison, Illinois, 60101

  • Cambridge Medical Trials

    Alexandria, Louisiana, 71301

  • Amarillo Heart Clinical Research Institute, Inc

    Amarillo, Texas, 79106

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • Synexus Clinical Research US, Inc.

    Atlanta, Georgia, 30328

  • Northern Light Cardiology

    Bangor, Maine, 04401

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401

  • American Institute of Research

    Beverly Hills, California, 90211

  • Central Alabama Research

    Birmingham, Alabama, 35209

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

    Birmingham, Alabama, 35211

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Grace Research, LLC

    Bossier City, Louisiana, 71111

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

    Bridgeton, New Jersey, 08302

  • East Coast Institute for Research - Canton

    Canton, Georgia, 30114

  • Centricity Research

    Columbus, Georgia, 31904

  • Javara Inc.

    Conroe, Texas, 77384

  • Prime Revival Research Institute, LLC

    Coppell, Texas, 75019

  • Thyroid, Endocrinology & Diabetes, PA

    Dallas, Texas, 75208

  • Synexus Clinical Research US, Inc.

    Evansville, Indiana, 47714

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Pioneer Clinical Studies

    Ft. Pierce, Florida, 34950

  • New Generation of Medical Research

    Hialeah, Florida, 33016

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32204

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

    Jacksonville, Florida, 32216

  • East Coast Institute for Research- Lake City

    Lake City, Florida, 32055

  • AB Clinical Trials

    Las Vegas, Nevada, 89119

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

    Louisville, Kentucky, 40213

  • East Coast Institute for Research, LLC

    Macon, Georgia, 31210

  • ClinCloud LLC

    Maitland, Florida, 32751

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Tandem Clinical Research GI - Metairie

    Metairie, Louisiana, 70006

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125

  • Kendall South Medical Center, Inc.

    Miami, Florida, 33185

  • Diabetes and Endocrinology Consultants, P.C.

    Morehead City, North Carolina, 28557

  • Advanced Research Institute Inc

    New Port Richey, Florida, 34653

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • Synexus Clinical Research US, Inc.

    New York, New York, 10017

  • Tandem Clinical Research GI, LLC

    New York, New York, 10033

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • Alta Pharmaceutical Research Center

    Peachtree Corners, Georgia, 30092

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Cardiovascular Research of Knoxville, LLC

    Powell, Tennessee, 37849

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • East Coast Institute for Research

    Saint Augustine, Florida, 32086

  • Synexus Clinical Research US, Inc.

    Salt Lake City, Utah, 84106

  • The Center for Clinical Trials, Inc

    Saraland, Alabama, 36571

  • SouthCoast Health

    Savannah, Georgia, 31406

  • Syed Research Consultants, LLC

    Sheffield, Alabama, 35660

  • Grace Research, LLC

    Shreveport, Louisiana, 71105

  • Privia Medical Group, LLC

    Silver Spring, Maryland, 20901

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077

  • Summit Research Group, LLC

    Stow, Ohio, 44224

  • Hampton Roads Center for Clinical Research

    Suffolk, Virginia, 23434

  • Clinical Research Institute of Arizona, LLC

    Sun City West, Arizona, 85375

  • Universal Research Group, LLC

    Tacoma, Washington, 98405

  • Chear Center LLC

    The Bronx, New York, 10455

  • Synexus Clinical Research US, Inc.

    The Villages, Florida, 32162

  • Northwest Houston Clinical Research

    Tomball, Texas, 77375

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Oakland Medical Research

    Troy, Michigan, 48085

  • Arcturus Healthcare, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

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

    Tucson, Arizona, 85741

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

  • Orange County Research Center

    Tustin, California, 92780

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083

  • Southern Clinical Research, LLC

    Zachary, Louisiana, 70791

Other trials in United States

China29 sites

  • Peking University First Hospital

    Beijing, 100034

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233017

  • Cangzhou Central Hospital

    Cangzhou, 61017

  • China-Japan Union Hospital Of Jilin University

    Changchun, 130033

  • The First People's Hospital of Changde City

    Changde, 415003

  • The Second People's Hospital of Changzhou

    Changzhou, 213164

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Affiliated Hospital of Chifeng University

    Chifeng, 24050

  • Chifeng Municipal Hospital

    Chifeng, 24099

  • Daqing People's Hospital

    Daqing, 163711

  • Foshan First People's Hospital

    Foshan, 528010

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The Third Affiliated Hospital of Guangzhou Medical university

    Guangzhou, 510150

  • Heilongjiang Provincial Hospital

    Harbin, 150036

  • The First Affiliated Hospital Of University Of South China

    Hunan, 421001

  • Jinan Central Hospital

    Jinan, 250013

  • Hebei Petro China Central Hospital

    Langfang, 65099

  • Lishui Central Hospital

    Lishui, 323020

  • Luoyang Third People's Hospital

    Luoyang, 471002

  • The First affiliated Hospital of Nanyang Medical College

    Nanyang, 473024

  • Panjin Liaoyou Gem Flower Hospital

    Panjin, 124010

  • Huabei Petroleum Administration Bureau General Hospital

    Renqiu, 62550

  • Tianjin People's Hospital

    Tianjin, 300121

  • Tianjin Fourth Central Hospital

    Tianjin, 300143

  • Wenzhou People's Hospital

    Wenzhou, 325099

  • Xi'an Gaoxin Hospital

    Xi'an, 710075

  • Xianyang Hospital of Yan 'an University

    Xianyang, 712099

  • The Third Affiliatied Hospital of Xinxiang Medical University

    Xinxiang, 453000

  • Zaozhuang Municipal Hospital

    Zaozhuang, 277102

Other trials in China

Poland21 sites

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

    Bydgoszcz, 85-231

  • CENTRUM MEDYCZNE INTERCOR Sp. z o.o.

    Bydgoszcz, 85-605

  • NZOZ Twoje Zdrowie EL Sp. z o.o.

    Elblag, 82-300

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

    Gdynia, 81-157

  • Silmedic Sp. z o.o.

    Katowice, 40-282

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501

  • FutureMeds Lodz

    Lodz, 91-363

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus

    Lodz, 94-255

  • Clinical Best Solutions - Lublin

    Lublin, 20-078

  • KO - MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • Futuremeds Olsztyn

    Olsztyn, 10-010

  • Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik

    Ostrowiec Świętokrzyski, 27-400

  • Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia

    Ruda Śląska, 41-710

  • Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna

    Staszów, 28-200

  • Prywatny Gabinet Lekarski Jacek Gessek

    Torun, 87-100

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215

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

    Warsaw, 00-710

  • FutureMeds Targowek

    Warsaw, 03-291

  • FutureMeds Sp. z o.o

    Wroclaw, 50-088

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

    Wroclaw, 50-981

Other trials in Poland

Netherlands20 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

  • Academic Medical Center - Department of Vascular Medicine

    Amsterdam, 1105 AZ

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

  • Tergooiziekenhuizen Blaricum

    Blaricum, 1261 AN

  • IJsselland ziekenhuis

    Capelle aan den IJssel, 2906 ZC

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD

  • Ziekenhuis Deventer

    Deventer, 7416 SE

  • Slingeland Ziekenhuis

    Doetinchem, 7009 BL

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • St. Jansdal Ziekenhuis

    Harderwijk, 3844 DG

  • Canisius-Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, 6532 SZ

  • Laurentius Hospital Roermond

    Roermond, 6043 CV

  • Bravis ziekenhuis - Locatie Roosendaal

    Roosendaal, 4708 AE

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

  • VieCuri Medisch Centrum

    Venlo, 5912 BL

  • Gelre Ziekenhuizen - Locatie Zutphen

    Zutphen, 7207 AE

  • Albert Schweitzer Ziekenhuis - Location Dordrecht

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

Japan17 sites

  • Chiba University Hospital

    Chiba, 260-8677

  • New Tokyo Heart Clinic

    Chiba, 271-0077

  • Japan Community Health Care Organization Kyushu Hospital

    Fukuoka, 806-8501

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Hyōgo, 670-8560

  • Ishikawa Prefectural Central Hospital

    Ishikawa, 920-8530

  • Komatsu Municipal Hospital

    Ishikawa, 923-8560

  • Public Central Hospital of Matto lshikawa

    Ishikawa, 924-8588

  • Showa University Northern Yokohama Hospital

    Kanagawa, 224-8503

  • Kokura Memorial Hospital

    Kitakyushu, 802-8555

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8510

  • The Sakakibara Heart Institute of Okayama

    Okayama, 700-0804

  • Sakurabashi Watanabe Hospital

    Osaka, 530-0001

  • National Cerebral and Cardiovascular Center Research Institute

    Osaka, 565-8565

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, 569-8686

  • Tokyo Saiseikai Central Hospital

    Tokyo, 108-0073

Other trials in Japan

Czechia11 sites

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

    Bílina, 418 01

  • Medicus Services SRO

    Brandýs nad Labem, 250 01

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

    Brno, 603 00

  • Kardiologicka ambulance Brno s.r.o.

    Brno, 612 00

  • Cevni ambulance - MATMED s.r.o.

    Hodonín, 695 01

  • MUDr. Tomas Edelsberger - diabetologicka ambulance

    Krnov, 794 01

  • KARDIOLOGIE - LIBEREC s.r.o.

    Liberec, 46014

  • PreventaMed s.r.o.

    Olomouc, 779 00

  • CCR Ostrava s.r.o.

    Ostrava, 702 00

  • CCR Czech a.s.

    Pardubice, 530 02

  • Kardiologie COR s.r.o.

    Prague, 106 00

Other trials in Czechia

Georgia9 sites

  • Health LTD

    Batumi, 6004

  • JSC Curatio

    Tbilisi, 0114

  • Acad. G. Chapidze Emergency Cardiology Center LTD

    Tbilisi, 0159

  • Bokhua Memorial Cardiovascular Center LTD

    Tbilisi, 0159

  • Vitamedi LTD

    Tbilisi, 0159

  • Medi Club Georgia LLC

    Tbilisi, 0160

  • Georgian-Ducht Hospital LTD

    Tbilisi, 0172

  • The First Medical Center LTD

    Tbilisi, 0180

  • Adapti LTD

    Tbilisi, 0186

Other trials in Georgia

Denmark5 sites

  • Aarhus University Hospital

    Aarhus, 8200

  • Amager Hospital

    Copenhagen S, 2300

  • Sydvestjysk Hospital

    Esbjerg, 6700

  • Godstrup Regional Hospital (Gødstrup)

    Herning, 7400

  • Viborg Regional Hospital

    Viborg, 8800

Other trials in Denmark

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10mg Obicetrapib in Participants With HeFH and/or ASCVD Who Are Not Adequately Controlled by Their Lipid Modifying Therapies

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy

Read the detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying HeFH and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 28 days. Afterwards patients will be randomized to placebo or 10 mg obicetrapib for a 365 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

Being tested
Placebo, Obicetrapib
Keywords
obicetrapib, BROADWAY, Cholesteryl ester transfer protein (CETP) inhibitor, Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD)
Medical subject headings
Dyslipidemias, Hypercholesterolemia, Hyperlipoproteinemia Type II, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    placebo tablet made to resemble active

  • ObicetrapibDrug

    10mg obicetrapib tablet

Study groups in NCT05142722
Study groupRoleWhat they receive
PlaceboPlacebo comparatorone placebo tablet once daily
Receives: Drug: Placebo
obicetrapib 10mgExperimentalone 10mg obicetrapib tablet once daily
Receives: Drug: Obicetrapib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]

    LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Measured: 84 Days

Secondary outcomes (19)

  1. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]

    LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [Martin/Hopkins]. LDL-C value was calculated using the Martin/Hopkins equation unless TG >= 400 mg/dL or LDL-C <= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).

    Measured: 180 Days

  2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]

    LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Measured: 365 Days

  3. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

    Measured: 84 Days

  4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

    Measured: 180 Days

  5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

    Measured: 365 Days

  6. Percent Change in Non-HDL-C From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group.

    Measured: 84 Days

  7. Percent Change in Non-HDL-C From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.

    Measured: 180 Days

  8. Percent Change in Non-HDL-C From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.

    Measured: 365 Days

  9. Percent Change in HDL-C From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

    Measured: 84 Days

  10. Percent Change in HDL-C From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

    Measured: 180 Days

  11. Percent Change in HDL-C From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

    Measured: 365 Days

  12. Percent Change in Lp(a) From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group.

    Measured: 84 Days

  13. Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Apolipoprotein A1 (ApoA1) in obicetrapib group compared to the placebo group.

    Measured: 84 Days

  14. Percent Change in Total Cholesterol From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group.

    Measured: 84 Days

  15. Percent Change in Total Cholesterol From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group.

    Measured: 180 Days

  16. Percent Change in Total Cholesterol From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group.

    Measured: 365 Days

  17. Percent Change in Triglycerides From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group.

    Measured: 84 Days

  18. Percent Change in Triglycerides From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group.

    Measured: 180 Days

  19. Percent Change in Triglycerides From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group.

    Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start15 Dec 2021
  3. Primary completion26 Sep 2024
  4. Study completion26 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Placebo-controlled, double-blind, randomized
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05142722
Sponsor's protocol ID
TA-8995-302
Acronym
BROADWAY
Status last verified
Feb 2025
First submitted
18 Nov 2021
Last updated
19 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nicholls SJ, Nelson AJ, Ditmarsch M, Kastelein JJP, Ballantyne CM, Ray KK, Navar AM, Nissen SE, Goldberg AC, Brunham LR, Curcio D, Wuerdeman E, Neild A, Kling D, Hsieh A, Dicklin MR, Ference BA, Laufs U, Banach M, Mehran R, Catapano AL, Davidson MH. Obicetrapib on top of maximally tolerated lipid-modifying therapies in participants with or at high risk for atherosclerotic cardiovascular disease: rationale and designs of BROADWAY and BROOKLYN. Am Heart J. 2024 Aug;274:32-45. doi: 10.1016/j.ahj.2024.05.002. Epub 2024 May 4.

    PubMed 38705341

  • Nicholls SJ, Nelson AJ, Ditmarsch M, Kastelein JJP, Ballantyne CM, Ray KK, Navar AM, Nissen SE, Harada-Shiba M, Curcio DL, Neild A, Kling D, Hsieh A, Butters J, Ference BA, Laufs U, Banach M, Mehran R, Catapano AL, Huo Y, Szarek M, Balinskaite V, Davidson MH; BROADWAY Investigators. Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk. N Engl J Med. 2025 Jul 3;393(1):51-61. doi: 10.1056/NEJMoa2415820. Epub 2025 May 7.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Obicetrapib in people with Dyslipidemias and High Cholesterol, run by NewAmsterdam Pharma at 181 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 sites in United States, China, Poland, Netherlands, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] (time frame: 84 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05142722, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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