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DyslipidemiasPhase 3BROOKLYNNCT05425745

Evaluate the Effect of Obicetrapib in Patients With HeFH 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 96 sites in 10 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 to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH). 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
354 participants
Where
96 sitesin 10 countries
Study dates
25 Jul 2022to 28 May 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

  • 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)

Who cannot join

  • 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

Trial locations and contacts

96 sites in 10 countries.

96 sites in 10 countries

United States20 sites

  • Site 01007

    Baton Rouge, Louisiana, 70809

  • Site 01023

    Boise, Idaho, 83702

  • Site 01008

    Chattanooga, Tennessee, 37405

  • Site 01018

    Chicago, Illinois, 60602

  • Site 01016

    El Paso, Texas, 79905

  • Site 01013

    Houston, Texas, 76706

  • Site 01012

    Iowa City, Iowa, 52240

  • Site 01022

    Jonesboro, Arkansas, 72401

  • Site 01011

    Lincoln, Nebraska, 68510

  • Site 01020

    Morganton, North Carolina, 28655

  • Site 01002

    Morristown, New Jersey, 07960

  • Site 01010

    New Providence, New Jersey, 07901

  • Site 01004

    Norfolk, Nebraska, 68701

  • Site 01001

    North Massapequa, New York, 11758

  • Site 01005

    Port Gibson, Mississippi, 39105

  • Site 01009

    Sarasota, Florida, 34230

  • Site 01006

    St Louis, Missouri, 63130

  • Site 01014

    Suffolk, Virginia, 23434

  • Site 01015

    Toluca Lake, California, 91602

  • Site 01019

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain18 sites

  • Site 17004

    A Coruña, 15001

  • Site 017001

    Barcelona, 8036

  • Site 17002

    Barcelona, 8907

  • Site 17003

    Córdoba, 14004

  • Site 17018

    Figueras, 17600

  • Site 17011

    Granada, 18014

  • Site 17017

    Huelva, 21007

  • Site 17012

    Huesca, 22002

  • Site 17008

    Las Palmas de Gran Canaria, 35016

  • Site 17010

    Madrid, 28034

  • Site 17016

    Madrid, 28041

  • Site 17007

    Málaga, 29010

  • Site 17013

    Sabadell, 8208

  • Site 17015

    Santiago de Compostela, 15706

  • Site 17009

    Seville, 41009

  • Site 17006

    Seville, 41013

  • Site 17014

    Valencia, 46014

  • Site 17005

    Zaragoza, 50009

Other trials in Spain

United Kingdom11 sites

  • Site 014006

    Birmingham, B21 9RY

  • Site 014012

    Bristol, BS2 8HW

  • Site 014009

    Cardiff, CF14 4XW

  • Site 014010

    Chichester, PO19 6SE

  • Site 014001

    Dundee, DD1 9SY

  • Site 014002

    London, NW3 2QG

  • Site 014003

    Manchester, M23 9LT

  • Site 014008

    Metropolitan Borough of Wirral, CH62 6EE

  • Site 014011

    Penzance, TR19 7HU

  • Site 014005

    Stevenage, SG14AB

  • Site 014004

    West Bromwich, B71 4HJ

Other trials in United Kingdom

Georgia10 sites

  • Site 022001

    Batumi, 6000

  • Site 022003

    Tbilisi, 112

  • Site 022004

    Tbilisi, 131

  • Site 022010

    Tbilisi, 144

  • Site 022006

    Tbilisi, 159

  • Site 022007

    Tbilisi, 159

  • Site 022008

    Tbilisi, 159

  • Site 022002

    Tbilisi, 186

  • Site 022005

    Tbilisi, 186

  • Site 022009

    Tbilisi, 579

Other trials in Georgia

Canada9 sites

  • Site 06007

    Brampton, L6Z 4N5

  • Site 06008

    Chicoutimi, G7H 7K9

  • Site 06005

    Halifax, B3H 3A7

  • Site 06003

    Montreal, H2W 1R7

  • Site 06009

    Montreal, H3A 1A1

  • Site 06004

    Québec, G1V 4W2

  • Site 06006

    Sherbrooke, J1H 5N4

  • Site 06001

    Vancouver, V6Z 2C7

  • Site 06002

    Victoria, V8T 5G4

Other trials in Canada

South Africa9 sites

  • Site 018001

    Bloemfontein, 9301

  • Site 018002

    Cape Town, 7530

  • Site 018009

    Centurion, 154

  • Site 018006

    Centurion, 157

  • Site 018004

    Parow, 7500

  • Site 018003

    Somerset West, 7130

  • Site 018005

    Somerset West, 7130

  • Site 018007

    Tongaat, 4400

  • Site 018008

    Umhlanga, 4321

Other trials in South Africa

Czechia6 sites

  • Site 02006

    Brno, 65691

  • Site 02002

    Hradec Králové, 500 05

  • Site 02003

    Prague, 128 08

  • Site 02005

    Prague, 140 21

  • Site 02004

    Prague, 15006

  • Site 02001

    Uherské Hradiště, 686 01

Other trials in Czechia

Netherlands6 sites

  • Site 04001

    Amsterdam, 1105AZ

  • Site 04003

    Arnhem, 6815 AD

  • Site 04002

    Deventer, 7416 SE

  • Site 04004

    Eindhoven, 5631 BM

  • Site 04005

    Roosendaal, 4708 AE

  • Site 04006

    Rotterdam, 3015 GD

Other trials in Netherlands

Poland5 sites

  • Site 05002

    Bialystok, 15-276

  • Site 05003

    Lodz, 92-213

  • Site 05004

    Lodz, 93-338

  • Site 05005

    Zabrze, 41-800

  • Site 05001

    Zamość, 22-400

Other trials in Poland

Norway2 sites

  • Site 023003

    Bodø, 8008

  • Site 023002

    Oslo, 587

Other trials in Norway

About this study

Official title: 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

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).

Read the detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with HeFH 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 14 days. Afterwards, patients will be randomized to placebo or 10 mg obicetrapib for an 365-day treatment period. After the treatment period, participants will have an end-of-study follow-up visit.

Being tested
Obicetrapib, Placebo
Keywords
Obicetrapib, BROOKLYN, Cholesteryl ester transfer protein (CETP) inhibitor, Heterozygous Familial Hypercholesterolemia (HeFH), LDL-C
Medical subject headings
Dyslipidemias, Hypercholesterolemia, Hyperlipoproteinemia Type II, Lipid Metabolism Disorders, Metabolic Diseases, Lipid Metabolism, Inborn Errors, Genetic Diseases, Inborn, Hyperlipoproteinemias

What participants receive

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

  • ObicetrapibDrug

    Also called CETP-inhibitor

    10 mg Obicetrapib tablet

  • PlaceboDrug

    placebo tablet made to resemble active

Study groups in NCT05425745
Study groupRoleWhat they receive
PlaceboPlacebo comparatorone placebo tablet once daily
Receives: Drug: Placebo
Obicetrapib 10 mgExperimentalone 10 mg 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 Lp(a) From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group

    Measured: 365 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. Precent 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 posted21 Jun 2022
  2. Study start25 Jul 2022
  3. Primary completion28 May 2024
  4. Study completion28 May 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
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425745
Sponsor's protocol ID
TA-8995-301
Acronym
BROOKLYN
Status last verified
Jun 2025
First submitted
15 Jun 2022
Last updated
11 Jun 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, Wuerdeman E, Neild AL, Kling D, Hsieh A, Butters J, Ference BA, Laufs U, Banach M, Mehran R, Catapano AL, Szarek M, Balinskaite V, Davidson MH. Obicetrapib in patients with heterozygous familial hypercholesterolemia: the BROOKLYN randomized clinical trial. Nat Med. 2026 Mar;32(3):1052-1060. doi: 10.1038/s41591-025-04179-4. Epub 2026 Feb 27.

    PubMed 41760952

  • 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

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 96 sites in 10 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 3 inclusion and 6 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Spain, United Kingdom, Georgia, Canada and 5 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 11 Jun 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 NCT05425745, which also lists 2 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 11 Jun 2025.

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