Randomized Study in Patients With HeFH to Evaluate Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewAmsterdam Pharma

Criteria

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 and < 100 mg/dL (≥1.8 and <2.6 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