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Completed

NCT Number: NCT05425745

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated 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).

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Key information

Conditions

Dyslipidemias Congenital, Hereditary, and Neonatal Diseases and Abnormalities Familial Hypercholesterolemia Genetic Disease, Inborn Genetic Diseases, Inborn High Cholesterol Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorder Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Disease Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 06007, Brampton, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Obicetrapib

Drug

10 mg Obicetrapib tablet

Other names: CETP-inhibitor

Placebo

Drug

placebo tablet made to resemble active

Primary outcomes

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

    Time frame: 84 Days

    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).

Secondary outcomes

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

    Time frame: 180 Days

    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).

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

    Time frame: 365 Days

    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).

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

    Time frame: 84 Days

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

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

    Time frame: 180 Days

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

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

    Time frame: 365 Days

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

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

    Time frame: 84 Days

    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

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

    Time frame: 180 Days

    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

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

    Time frame: 365 Days

    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

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

    Time frame: 84 Days

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

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

    Time frame: 180 Days

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

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

    Time frame: 365 Days

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

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

    Time frame: 84 Days

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

  13. Percent Change in Lp(a) From Baseline to Day 365

    Time frame: 365 Days

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

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

    Time frame: 84 Days

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

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

    Time frame: 180 Days

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

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

    Time frame: 365 Days

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

  17. Percent Change in Triglycerides From Baseline to Day 84

    Time frame: 84 Days

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

  18. Percent Change in Triglycerides From Baseline to Day 180

    Time frame: 180 Days

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

  19. Precent Change in Triglycerides From Baseline to Day 365

    Time frame: 365 days

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

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Registry information

Official study 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

Acronym: BROOKLYN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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