Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
BROADWAY
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
1 other identifier
interventional
2,530
8 countries
181
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2021
Typical duration for phase_3
181 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2021
CompletedFirst Posted
Study publicly available on registry
December 3, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2024
CompletedResults Posted
Study results publicly available
September 19, 2025
CompletedSeptember 19, 2025
February 1, 2025
2.8 years
November 18, 2021
September 2, 2025
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
84 Days
Secondary Outcomes (19)
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]
180 Days
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]
365 Days
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84
84 Days
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180
180 Days
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365
365 Days
- +14 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORone placebo tablet once daily
obicetrapib 10mg
EXPERIMENTALone 10mg obicetrapib tablet once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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);
- +10 more criteria
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (181)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Central Alabama Research
Birmingham, Alabama, 35209, United States
Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PC
Birmingham, Alabama, 35211, United States
The Center for Clinical Trials, Inc
Saraland, Alabama, 36571, United States
Syed Research Consultants, LLC
Sheffield, Alabama, 35660, United States
Clinical Research Institute of Arizona, LLC
Sun City West, Arizona, 85375, United States
Synexus Clinical Research US, Inc. / Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Eclipse Clinical Research
Tucson, Arizona, 85745, United States
American Institute of Research
Beverly Hills, California, 90211, United States
Orange County Research Center
Tustin, California, 92780, United States
Synexus Clinical Research US, Inc.
Vista, California, 92083, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Pioneer Clinical Studies
Ft. Pierce, Florida, 34950, United States
New Generation of Medical Research
Hialeah, Florida, 33016, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204, 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
ClinCloud LLC
Maitland, Florida, 32751, United States
Columbus Clinical Services, LLC
Miami, Florida, 33125, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
Advanced Research Institute Inc
New Port Richey, Florida, 34653, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
East Coast Institute for Research
Saint Augustine, Florida, 32086, United States
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328, United States
East Coast Institute for Research - Canton
Canton, Georgia, 30114, United States
Centricity Research
Columbus, Georgia, 31904, United States
East Coast Institute for Research, LLC
Macon, Georgia, 31210, United States
Alta Pharmaceutical Research Center
Peachtree Corners, Georgia, 30092, United States
SouthCoast Health
Savannah, Georgia, 31406, United States
Biofortis, Inc
Addison, Illinois, 60101, United States
Evanston Premier Healthcare Research LLC
Skokie, Illinois, 60077, United States
Synexus Clinical Research US, Inc.
Evansville, Indiana, 47714, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
Cambridge Medical Trials
Alexandria, Louisiana, 71301, United States
Grace Research, LLC
Bossier City, Louisiana, 71111, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Tandem Clinical Research GI - Metairie
Metairie, Louisiana, 70006, United States
Grace Research, LLC
Shreveport, Louisiana, 71105, United States
Southern Clinical Research, LLC
Zachary, Louisiana, 70791, United States
Northern Light Cardiology
Bangor, Maine, 04401, United States
Privia Medical Group, LLC
Silver Spring, Maryland, 20901, United States
Oakland Medical Research
Troy, Michigan, 48085, United States
Arcturus Healthcare, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Inspira Medical Centers dba Internal Medicine Associates, P.A.
Bridgeton, New Jersey, 08302, United States
Mid Hudson Medical Research
New Windsor, New York, 12553, United States
Synexus Clinical Research US, Inc.
New York, New York, 10017, United States
Tandem Clinical Research GI, LLC
New York, New York, 10033, United States
Chear Center LLC
The Bronx, New York, 10455, United States
Diabetes and Endocrinology Consultants, P.C.
Morehead City, North Carolina, 28557, United States
Lillestol Research, LLC
Fargo, North Dakota, 58104, United States
Summit Research Group, LLC
Stow, Ohio, 44224, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
Cardiovascular Research of Knoxville, LLC
Powell, Tennessee, 37849, United States
Amarillo Heart Clinical Research Institute, Inc
Amarillo, Texas, 79106, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
Apex Mobile Clinical Research
Bellaire, Texas, 77401, United States
Javara Inc.
Conroe, Texas, 77384, United States
Prime Revival Research Institute, LLC
Coppell, Texas, 75019, United States
Thyroid, Endocrinology & Diabetes, PA
Dallas, Texas, 75208, United States
Northwest Houston Clinical Research
Tomball, Texas, 77375, United States
Synexus Clinical Research US, Inc.
Salt Lake City, Utah, 84106, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Hampton Roads Center for Clinical Research
Suffolk, Virginia, 23434, United States
Universal Research Group, LLC
Tacoma, Washington, 98405, United States
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Peking University First Hospital
Beijing, 100034, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233017, China
Cangzhou Central Hospital
Cangzhou, 61017, China
China-Japan Union Hospital Of Jilin University
Changchun, 130033, China
The First People's Hospital of Changde City
Changde, 415003, China
The Second People's Hospital of Changzhou
Changzhou, 213164, China
Affiliated Hospital of Chifeng University
Chifeng, 24050, China
Chifeng Municipal Hospital
Chifeng, 24099, China
Daqing People's Hospital
Daqing, 163711, China
Foshan First People's Hospital
Foshan, 528010, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
The Third Affiliated Hospital of Guangzhou Medical university
Guangzhou, 510150, China
Heilongjiang Provincial Hospital
Harbin, 150036, China
The First Affiliated Hospital Of University Of South China
Hunan, 421001, China
Jinan Central Hospital
Jinan, 250013, China
Hebei Petro China Central Hospital
Langfang, 65099, China
Lishui Central Hospital
Lishui, 323020, China
Luoyang Third People's Hospital
Luoyang, 471002, China
The First affiliated Hospital of Nanyang Medical College
Nanyang, 473024, China
Panjin Liaoyou Gem Flower Hospital
Panjin, 124010, China
Huabei Petroleum Administration Bureau General Hospital
Renqiu, 62550, China
Tianjin People's Hospital
Tianjin, 300121, China
Tianjin Fourth Central Hospital
Tianjin, 300143, China
Wenzhou People's Hospital
Wenzhou, 325099, China
Xi'an Gaoxin Hospital
Xi'an, 710075, China
Xianyang Hospital of Yan 'an University
Xianyang, 712099, China
The Third Affiliatied Hospital of Xinxiang Medical University
Xinxiang, 453000, China
Zaozhuang Municipal Hospital
Zaozhuang, 277102, China
Hornicka nemocnice s poliklinikou Bilina s.r.o.
Bílina, 418 01, Czechia
Medicus Services SRO
Brandýs nad Labem, 250 01, Czechia
Centrum pro zdravi - kardiologie s.r.o.
Brno, 603 00, Czechia
Kardiologicka ambulance Brno s.r.o.
Brno, 612 00, Czechia
Cevni ambulance - MATMED s.r.o.
Hodonín, 695 01, Czechia
MUDr. Tomas Edelsberger - diabetologicka ambulance
Krnov, 794 01, Czechia
KARDIOLOGIE - LIBEREC s.r.o.
Liberec, 46014, Czechia
PreventaMed s.r.o.
Olomouc, 779 00, Czechia
CCR Ostrava s.r.o.
Ostrava, 702 00, Czechia
CCR Czech a.s.
Pardubice, 530 02, Czechia
Kardiologie COR s.r.o.
Prague, 106 00, Czechia
Aarhus University Hospital
Aarhus, 8200, Denmark
Amager Hospital
Copenhagen S, 2300, Denmark
Sydvestjysk Hospital
Esbjerg, 6700, Denmark
Godstrup Regional Hospital (Gødstrup)
Herning, 7400, Denmark
Viborg Regional Hospital
Viborg, 8800, Denmark
Health LTD
Batumi, 6004, Georgia
JSC Curatio
Tbilisi, 0114, Georgia
Acad. G. Chapidze Emergency Cardiology Center LTD
Tbilisi, 0159, Georgia
Bokhua Memorial Cardiovascular Center LTD
Tbilisi, 0159, Georgia
Vitamedi LTD
Tbilisi, 0159, Georgia
Medi Club Georgia LLC
Tbilisi, 0160, Georgia
Georgian-Ducht Hospital LTD
Tbilisi, 0172, Georgia
The First Medical Center LTD
Tbilisi, 0180, Georgia
Adapti LTD
Tbilisi, 0186, Georgia
Chiba University Hospital
Chiba, 260-8677, Japan
New Tokyo Heart Clinic
Chiba, 271-0077, Japan
Japan Community Health Care Organization Kyushu Hospital
Fukuoka, 806-8501, Japan
Hiroshima Prefectural Hospital
Hiroshima, 734-8530, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Hyōgo, 670-8560, Japan
Ishikawa Prefectural Central Hospital
Ishikawa, 920-8530, Japan
Komatsu Municipal Hospital
Ishikawa, 923-8560, Japan
Public Central Hospital of Matto lshikawa
Ishikawa, 924-8588, Japan
Showa University Northern Yokohama Hospital
Kanagawa, 224-8503, Japan
Kokura Memorial Hospital
Kitakyushu, 802-8555, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8510, Japan
The Sakakibara Heart Institute of Okayama
Okayama, 700-0804, Japan
Sakurabashi Watanabe Hospital
Osaka, 530-0001, Japan
National Cerebral and Cardiovascular Center Research Institute
Osaka, 565-8565, Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, 569-8686, Japan
Tokyo Saiseikai Central Hospital
Tokyo, 108-0073, Japan
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC, Netherlands
Academic Medical Center - Department of Vascular Medicine
Amsterdam, 1105 AZ, Netherlands
Ziekenhuis Rijnstate
Arnhem, 6815 AD, Netherlands
Tergooiziekenhuizen Blaricum
Blaricum, 1261 AN, Netherlands
IJsselland ziekenhuis
Capelle aan den IJssel, 2906 ZC, Netherlands
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
Ziekenhuis Deventer
Deventer, 7416 SE, Netherlands
Slingeland Ziekenhuis
Doetinchem, 7009 BL, Netherlands
Martini Ziekenhuis
Groningen, 9728 NT, Netherlands
St. Jansdal Ziekenhuis
Harderwijk, 3844 DG, Netherlands
Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen, 6532 SZ, Netherlands
Laurentius Hospital Roermond
Roermond, 6043 CV, Netherlands
Bravis ziekenhuis - Locatie Roosendaal
Roosendaal, 4708 AE, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083 AN, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
VieCuri Medisch Centrum
Venlo, 5912 BL, Netherlands
Gelre Ziekenhuizen - Locatie Zutphen
Zutphen, 7207 AE, Netherlands
Albert Schweitzer Ziekenhuis - Location Dordrecht
Zwijndrecht, 3331 LZ, Netherlands
Centrum Medyczne Kermed - Renata Bijata-Bronisz I Ewa Kowalinska Spólka Jawna
Bydgoszcz, 85-231, Poland
CENTRUM MEDYCZNE INTERCOR Sp. z o.o.
Bydgoszcz, 85-605, Poland
NZOZ Twoje Zdrowie EL Sp. z o.o.
Elblag, 82-300, Poland
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
Gdynia, 81-157, Poland
Silmedic Sp. z o.o.
Katowice, 40-282, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, 31-501, Poland
FutureMeds Lodz
Lodz, 91-363, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
Lodz, 94-255, Poland
Clinical Best Solutions - Lublin
Lublin, 20-078, Poland
KO - MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
Futuremeds Olsztyn
Olsztyn, 10-010, Poland
Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik
Ostrowiec Świętokrzyski, 27-400, Poland
Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia
Ruda Śląska, 41-710, Poland
Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
Staszów, 28-200, Poland
Prywatny Gabinet Lekarski Jacek Gessek
Torun, 87-100, Poland
FutureMeds Warszawa Centrum
Warsaw, 00-215, Poland
Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
Warsaw, 00-710, Poland
FutureMeds Targowek
Warsaw, 03-291, Poland
FutureMeds Sp. z o.o
Wroclaw, 50-088, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
Wroclaw, 50-981, Poland
Related Publications (3)
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.
PMID: 38705341BACKGROUNDNicholls 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.
PMID: 40337982RESULTDavidson MH, Szarek M, Scheltens P, Vijverberg E, Hsieh A, Ditmarsch M, Kling D, Curcio D, Nicholls SJ, Ray KK, Cummings JL, Kastelein JJ. Effect of obicetrapib, a potent cholesteryl ester transfer protein inhibitor, on p-tau217 levels in patients with cardiovascular disease. J Prev Alzheimers Dis. 2026 Jan;13(1):100394. doi: 10.1016/j.tjpad.2025.100394. Epub 2025 Oct 17.
PMID: 41109840DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- NewAmsterdam Pharma
Study Officials
- STUDY DIRECTOR
Marc Ditmarsch
NewAmsterdam Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- placebo tablet made to resemble active
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2021
First Posted
December 3, 2021
Study Start
December 15, 2021
Primary Completion
September 26, 2024
Study Completion
September 26, 2024
Last Updated
September 19, 2025
Results First Posted
September 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share