Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY)

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Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY)

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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

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. 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;
  2. Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD
  3. Are on maximally tolerated lipid-modifying therapy, defined as follows:
    • maximally tolerated statin, at a stable dose for at least 4 weeks prior to Screening
    • Atorvastatin 40 or 80 mg; or
    • Rosuvastatin 20 or 40 mg;
    • Ezetimibe for at least 4 weeks prior to Screening
    • Bempedoic acid for at least 4 weeks prior to Screening
    • A PCSK-9 targeted therapy for at least 3 stable doses prior to Screening
    • A fibrate at a stable dose for at least 6 weeks prior to Screening (with the exception of gemfibrozil, which is not allowed); and / or
    • Statin intolerant participants and participants using a statin at a maximally tolerated stable dose may be on any of the following or combinations of ezetimibe, bempedoic acid, a PCSK9-targeted therapy, or a fibrate as defined in the previous bullets.
  4. Have a fasting serum LDL-C as follows:
    • Fasting serum LDL-C ≥70 and < 100 mg/dL (≥1.8 and <2.6 mmol/L) with at least 1 of the following risk enhancers at Screening:
      • Recent MI (> 3 and < 12 months prior to Randomization);
      • Type 2 diabetes mellitus;
      • Fasting triglycerides (TG) > 150 mg/dL (>1.7 mmol/L);
      • Fasting lipoprotein (a) > 30 mg/dL (>70 nmol/L); and/or
      • Fasting HDL-C < 40 mg/dL (<1.0 mmol/L); OR
      • Fasting serum LDL-C ≥ 100 mg/dL
  5. Fasting triglyceride (TG) < 400 mg/dL (<4.52 mmol/L) at Screening
  6. Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at Screening
Exclusion Criteria
  1. New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction < 30%;
  2. Hospitalized for heart failure within 5 years prior to Screening
  3. Major adverse cardiac event (MACE) within 3 months prior to Screening;
  4. Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization;
  5. Formal diagnosis of homozygous familial hypercholesterolemia (HoFH);
  6. Active liver disease;
  7. HbA1c ≥10% at Screening;
  8. Thyroid-stimulating hormone >1.5 X upper limit of normal (ULN) at Screening;
  9. Creatine kinase 3 X upper limit of normal (ULN) at Screening;
  10. 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;
  11. Known history of alcohol and/or drug abuse within 5 years prior to Screening;
  12. 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;
  13. Planned use of other investigational products or devices during the course of the study;
  14. Participated in any clinical trial evaluating obicetrapib; or
  15. Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
  16. Any condition that, according to the Investigator, could interfere with the conduct of the study
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