Status:
COMPLETED
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
Lead Sponsor:
NewAmsterdam Pharma
Conditions:
Dyslipidemias
High Cholesterol
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Famili...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT05425745
Start Date
July 25 2022
End Date
May 28 2024
Last Update
June 11 2025
Active Locations (96)
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1
Site 01022
Jonesboro, Arkansas, United States, 72401
2
Site 01015
Toluca Lake, California, United States, 91602
3
Site 01009
Sarasota, Florida, United States, 34230
4
Site 01023
Boise, Idaho, United States, 83702