Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
NCT ID: NCT05425745
Last Updated: 2025-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2022-07-25
2024-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
one placebo tablet once daily
Placebo
placebo tablet made to resemble active
Obicetrapib 10 mg
one 10 mg Obicetrapib tablet once daily
Obicetrapib
10 mg Obicetrapib tablet
Interventions
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Obicetrapib
10 mg Obicetrapib tablet
Placebo
placebo tablet made to resemble active
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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NewAmsterdam Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Ditmarsch
Role: STUDY_DIRECTOR
NewAmsterdam Pharma
Locations
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Site 01022
Jonesboro, Arkansas, United States
Site 01015
Toluca Lake, California, United States
Site 01009
Sarasota, Florida, United States
Site 01023
Boise, Idaho, United States
Site 01018
Chicago, Illinois, United States
Site 01012
Iowa City, Iowa, United States
Site 01007
Baton Rouge, Louisiana, United States
Site 01005
Port Gibson, Mississippi, United States
Site 01006
St Louis, Missouri, United States
Site 01011
Lincoln, Nebraska, United States
Site 01004
Norfolk, Nebraska, United States
Site 01002
Morristown, New Jersey, United States
Site 01010
New Providence, New Jersey, United States
Site 01001
North Massapequa, New York, United States
Site 01020
Morganton, North Carolina, United States
Site 01019
Winston-Salem, North Carolina, United States
Site 01008
Chattanooga, Tennessee, United States
Site 01016
El Paso, Texas, United States
Site 01013
Houston, Texas, United States
Site 01014
Suffolk, Virginia, United States
Site 06007
Brampton, , Canada
Site 06008
Chicoutimi, , Canada
Site 06005
Halifax, , Canada
Site 06003
Montreal, , Canada
Site 06009
Montreal, , Canada
Site 06004
Québec, , Canada
Site 06006
Sherbrooke, , Canada
Site 06001
Vancouver, , Canada
Site 06002
Victoria, , Canada
Site 02006
Brno, , Czechia
Site 02002
Hradec Králové, , Czechia
Site 02003
Prague, , Czechia
Site 02005
Prague, , Czechia
Site 02004
Prague, , Czechia
Site 02001
Uherské Hradiště, , Czechia
Site 022001
Batumi, , Georgia
Site 022003
Tbilisi, , Georgia
Site 022004
Tbilisi, , Georgia
Site 022010
Tbilisi, , Georgia
Site 022006
Tbilisi, , Georgia
Site 022007
Tbilisi, , Georgia
Site 022008
Tbilisi, , Georgia
Site 022002
Tbilisi, , Georgia
Site 022005
Tbilisi, , Georgia
Site 022009
Tbilisi, , Georgia
Site 04001
Amsterdam, , Netherlands
Site 04003
Arnhem, , Netherlands
Site 04002
Deventer, , Netherlands
Site 04004
Eindhoven, , Netherlands
Site 04005
Roosendaal, , Netherlands
Site 04006
Rotterdam, , Netherlands
Site 023003
Bodø, , Norway
Site 023002
Oslo, , Norway
Site 05002
Bialystok, , Poland
Site 05003
Lodz, , Poland
Site 05004
Lodz, , Poland
Site 05005
Zabrze, , Poland
Site 05001
Zamość, , Poland
Site 018001
Bloemfontein, , South Africa
Site 018002
Cape Town, , South Africa
Site 018009
Centurion, , South Africa
Site 018006
Centurion, , South Africa
Site 018004
Parow, , South Africa
Site 018003
Somerset West, , South Africa
Site 018005
Somerset West, , South Africa
Site 018007
Tongaat, , South Africa
Site 018008
Umhlanga, , South Africa
Site 17004
A Coruña, , Spain
Site 017001
Barcelona, , Spain
Site 17002
Barcelona, , Spain
Site 17003
Córdoba, , Spain
Site 17018
Figueras, , Spain
Site 17011
Granada, , Spain
Site 17017
Huelva, , Spain
Site 17012
Huesca, , Spain
Site 17008
Las Palmas de Gran Canaria, , Spain
Site 17010
Madrid, , Spain
Site 17016
Madrid, , Spain
Site 17007
Málaga, , Spain
Site 17013
Sabadell, , Spain
Site 17015
Santiago de Compostela, , Spain
Site 17009
Seville, , Spain
Site 17006
Seville, , Spain
Site 17014
Valencia, , Spain
Site 17005
Zaragoza, , Spain
Site 014006
Birmingham, , United Kingdom
Site 014012
Bristol, , United Kingdom
Site 014009
Cardiff, , United Kingdom
Site 014010
Chichester, , United Kingdom
Site 014001
Dundee, , United Kingdom
Site 014002
London, , United Kingdom
Site 014003
Manchester, , United Kingdom
Site 014008
Metropolitan Borough of Wirral, , United Kingdom
Site 014011
Penzance, , United Kingdom
Site 014005
Stevenage, , United Kingdom
Site 014004
West Bromwich, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TA-8995-301
Identifier Type: -
Identifier Source: org_study_id
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