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 and LDL-C ≥70 and <100 mg/dL 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 with additional risk factors
  3. Are on maximally tolerated lipid-modifying therapy, including a maximally tolerated statin, at a stable dose for at least 4 weeks
  4. Atorvastatin 40 or 80 mg; or
  5. Rosuvastatin 20 or 40 mg;
  6. Fasting serum LDL-C ≥70 and < 100 mg/dL (≥1.8 and <2.6 mmol/L);
  7. Fasting triglyceride (TG) < 400 mg/dL (<4.52 mmol/L); and
  8. Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min
Exclusion Criteria
  1. New York Heart Association class IV heart failure or last known left ventricular ejection fraction < 25%;
  2. Major adverse cardiac event (MACE) within 3 months prior to Randomization;
  3. Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg;
  4. Formal diagnosis of homozygous familial hypercholesterolemia (HoFH);
  5. Active liver disease;
  6. HbA1c ≥10%;
  7. Thyroid-stimulating hormone >1.5 X upper limit of normal (ULN);
  8. Creatine kinase 3 X upper limit of normal (ULN);
  9. History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior;
  10. Known history of alcohol and/or drug abuse within 5 years prior;
  11. Received treatment with other investigational products or devices within 30 days or 5 half-lives of the previous investigational product, whichever is longer;
  12. Planned use of other investigational products or devices during the course of the study;
  13. Participated in any clinical trial evaluating obicetrapib; or
  14. Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
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