Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
- Conditions
- Familial HypercholesterolemiaDyslipidemiasHigh CholesterolHypercholesterolemiaASCVD
- Interventions
- Combination Product: Combination TherapyOther: Obicetrapib PlaceboOther: Combination Therapy placeboOther: Ezetimibe Placebo
- Registration Number
- NCT06005597
- Lead Sponsor
- NewAmsterdam Pharma
- Brief Summary
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
- Detailed Description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors 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 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
- Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
- On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
- LDL-C ≥ 70 mg/dL
- Triglycerides < 500
- Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2
- History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction <30%
- Hospitalized for heart failure within the last 5 years
- Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
- Uncontrolled severe hypertension
- Diagnosis of homozygous FH
- Liver disease
- HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
- Thyroid-stimulating hormone >1.5 x upper limit of normal (ULN)
- History of malignancy
- Creatinine kinase (CK) >3 X ULN
- Alcohol abuse
- Treatment with investigational product
- Treatment with gemfibrozil or ezetimibe
- Previous participation in a trial evaluating obicetrapib
- Known allergy to study drugs, placebo or excipients in study drugs of placebo
- Other condition that would interfere with the conduct of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Therapy Combination Therapy once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Combination Therapy Obicetrapib Placebo once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Combination Therapy Ezetimibe Placebo once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Monotherapy obicetrapib Monotherapy obicetrapib once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib Combination Therapy placebo once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib Ezetimibe Placebo once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy ezetimibe Monotherapy ezetimibe once-daily ezetimibe 10 mg capsule, 2 placebo tablets Placebo Ezetimibe Placebo once-daily placebo tablets (2), placebo capsule Monotherapy ezetimibe Combination Therapy placebo once-daily ezetimibe 10 mg capsule, 2 placebo tablets Monotherapy ezetimibe Obicetrapib Placebo once-daily ezetimibe 10 mg capsule, 2 placebo tablets Placebo Combination Therapy placebo once-daily placebo tablets (2), placebo capsule Placebo Obicetrapib Placebo once-daily placebo tablets (2), placebo capsule
- Primary Outcome Measures
Name Time Method Effect of combination therapy compared to placebo on LDL-C 84-Days Percent Change in LDL-C
Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C 84-Days Percent Change in LDL-C
Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C 84-Days Percent Change in LDL-C
Effect of obicetrapib 10 mg monotherapy compared to placebo on LDL-C 84-Days Percent Change in LDL-C
- Secondary Outcome Measures
Name Time Method Effect of combination therapy compared to placebo on non-HDL-C 84-Days Percent Change in non-HDL-C
Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB) 84-Days Percent Change in ApoB
Effect of obicetrapib 10 mg monotherapy compared to placebo on non-HDL-C 84-Days Percentage Change in non-HDL-C
Effect of obicetrapib 10 mg monotherapy compared to placebo on ApoB 84-Days Percent Change in ApoB
Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C 84-Days Percent Change in non-HDL-C
Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB 84-Days Percent Change in ApoB
Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C 84-Days Percent Change in non-HDL-C
Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB 84-Days Percent Change in ApoB
Trial Locations
- Locations (45)
East Valley Diabetes & Endocrinology
🇺🇸Gilbert, Arizona, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Centricity Research - Columbus
🇺🇸Columbus, Georgia, United States
Center for Advanced Research and Education
🇺🇸Gainesville, Georgia, United States
NSC Research
🇺🇸Johns Creek, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Evanston Premier Healthcare Research LLC
🇺🇸Skokie, Illinois, United States
Cardiovascular Research of Northwest Indiana, LLC
🇺🇸Munster, Indiana, United States
Grace Research, LLC - Bossier City, LA
🇺🇸Bossier City, Louisiana, United States
Scroll for more (35 remaining)East Valley Diabetes & Endocrinology🇺🇸Gilbert, Arizona, United States