Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
BROOKLYN
A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH Who Are Not Adequately Controlled by Their Lipid Modifying Therapies
1 other identifier
interventional
354
10 countries
96
Brief Summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2022
96 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
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
July 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2024
CompletedResults Posted
Study results publicly available
June 11, 2025
CompletedJune 11, 2025
June 1, 2025
1.8 years
June 15, 2022
May 21, 2025
June 10, 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 10 mg
EXPERIMENTALone 10 mg Obicetrapib tablet once daily
Interventions
Eligibility Criteria
You may qualify if:
- Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of \> 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH)
- Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses
- Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)
You may not qualify if:
- New York Heart Association class II or IV heart failure or last known 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;
- HbA1c ≥10%, or fasting glucose
- Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
- Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
Site 01022
Jonesboro, Arkansas, 72401, United States
Site 01015
Toluca Lake, California, 91602, United States
Site 01009
Sarasota, Florida, 34230, United States
Site 01023
Boise, Idaho, 83702, United States
Site 01018
Chicago, Illinois, 60602, United States
Site 01012
Iowa City, Iowa, 52240, United States
Site 01007
Baton Rouge, Louisiana, 70809, United States
Site 01005
Port Gibson, Mississippi, 39105, United States
Site 01006
St Louis, Missouri, 63130, United States
Site 01011
Lincoln, Nebraska, 68510, United States
Site 01004
Norfolk, Nebraska, 68701, United States
Site 01002
Morristown, New Jersey, 07960, United States
Site 01010
New Providence, New Jersey, 07901, United States
Site 01001
North Massapequa, New York, 11758, United States
Site 01020
Morganton, North Carolina, 28655, United States
Site 01019
Winston-Salem, North Carolina, 27157, United States
Site 01008
Chattanooga, Tennessee, 37405, United States
Site 01016
El Paso, Texas, 79905, United States
Site 01013
Houston, Texas, 76706, United States
Site 01014
Suffolk, Virginia, 23434, United States
Site 06007
Brampton, L6Z 4N5, Canada
Site 06008
Chicoutimi, G7H 7K9, Canada
Site 06005
Halifax, B3H 3A7, Canada
Site 06003
Montreal, H2W 1R7, Canada
Site 06009
Montreal, H3A 1A1, Canada
Site 06004
Québec, G1V 4W2, Canada
Site 06006
Sherbrooke, J1H 5N4, Canada
Site 06001
Vancouver, V6Z 2C7, Canada
Site 06002
Victoria, V8T 5G4, Canada
Site 02006
Brno, 65691, Czechia
Site 02002
Hradec Králové, 500 05, Czechia
Site 02003
Prague, 128 08, Czechia
Site 02005
Prague, 140 21, Czechia
Site 02004
Prague, 15006, Czechia
Site 02001
Uherské Hradiště, 686 01, Czechia
Site 022001
Batumi, 6000, Georgia
Site 022003
Tbilisi, 112, Georgia
Site 022004
Tbilisi, 131, Georgia
Site 022010
Tbilisi, 144, Georgia
Site 022006
Tbilisi, 159, Georgia
Site 022007
Tbilisi, 159, Georgia
Site 022008
Tbilisi, 159, Georgia
Site 022002
Tbilisi, 186, Georgia
Site 022005
Tbilisi, 186, Georgia
Site 022009
Tbilisi, 579, Georgia
Site 04001
Amsterdam, 1105AZ, Netherlands
Site 04003
Arnhem, 6815 AD, Netherlands
Site 04002
Deventer, 7416 SE, Netherlands
Site 04004
Eindhoven, 5631 BM, Netherlands
Site 04005
Roosendaal, 4708 AE, Netherlands
Site 04006
Rotterdam, 3015 GD, Netherlands
Site 023003
Bodø, 8008, Norway
Site 023002
Oslo, 587, Norway
Site 05002
Bialystok, 15-276, Poland
Site 05003
Lodz, 92-213, Poland
Site 05004
Lodz, 93-338, Poland
Site 05005
Zabrze, 41-800, Poland
Site 05001
Zamość, 22-400, Poland
Site 018001
Bloemfontein, 9301, South Africa
Site 018002
Cape Town, 7530, South Africa
Site 018009
Centurion, 154, South Africa
Site 018006
Centurion, 157, South Africa
Site 018004
Parow, 7500, South Africa
Site 018003
Somerset West, 7130, South Africa
Site 018005
Somerset West, 7130, South Africa
Site 018007
Tongaat, 4400, South Africa
Site 018008
Umhlanga, 4321, South Africa
Site 17004
A Coruña, 15001, Spain
Site 017001
Barcelona, 8036, Spain
Site 17002
Barcelona, 8907, Spain
Site 17003
Córdoba, 14004, Spain
Site 17018
Figueras, 17600, Spain
Site 17011
Granada, 18014, Spain
Site 17017
Huelva, 21007, Spain
Site 17012
Huesca, 22002, Spain
Site 17008
Las Palmas de Gran Canaria, 35016, Spain
Site 17010
Madrid, 28034, Spain
Site 17016
Madrid, 28041, Spain
Site 17007
Málaga, 29010, Spain
Site 17013
Sabadell, 8208, Spain
Site 17015
Santiago de Compostela, 15706, Spain
Site 17009
Seville, 41009, Spain
Site 17006
Seville, 41013, Spain
Site 17014
Valencia, 46014, Spain
Site 17005
Zaragoza, 50009, Spain
Site 014006
Birmingham, B21 9RY, United Kingdom
Site 014012
Bristol, BS2 8HW, United Kingdom
Site 014009
Cardiff, CF14 4XW, United Kingdom
Site 014010
Chichester, PO19 6SE, United Kingdom
Site 014001
Dundee, DD1 9SY, United Kingdom
Site 014002
London, NW3 2QG, United Kingdom
Site 014003
Manchester, M23 9LT, United Kingdom
Site 014008
Metropolitan Borough of Wirral, CH62 6EE, United Kingdom
Site 014011
Penzance, TR19 7HU, United Kingdom
Site 014005
Stevenage, SG14AB, United Kingdom
Site 014004
West Bromwich, B71 4HJ, United Kingdom
Related Publications (1)
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: 38705341DERIVED
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
June 15, 2022
First Posted
June 21, 2022
Study Start
July 25, 2022
Primary Completion
May 28, 2024
Study Completion
May 28, 2024
Last Updated
June 11, 2025
Results First Posted
June 11, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share