Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Phase 3

Completed

• Conditions: Familial Hypercholesterolemia; Dyslipidemias; High Cholesterol; Hypercholesterolemia; ASCVD
• Interventions: Combination Product: Combination Therapy; Drug: Monotherapy obicetrapib; Drug: Monotherapy ezetimibe; Other: Obicetrapib Placebo; Other: Combination Therapy placebo; Other: 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.

Study Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-22
• Study Start: 2024-03-01
• Primary Completion: 2024-09-25
• Study Completion: 2024-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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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)

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

Grace Research, LLC - Bossier City, LA; 🇺🇸 Bossier City, Louisiana, United States

Novant Health Clinical Research, LLC; 🇺🇸 Charlotte, North Carolina, United States

Northern Pines Health Center; 🇺🇸 Buckley, Michigan, United States

Lucas Research, Inc; 🇺🇸 Morehead City, North Carolina, United States

PharmaTex Research, LLC; 🇺🇸 Amarillo, Texas, United States

Hampton Roads Center for Clinical Research; 🇺🇸 Suffolk, Virginia, United States

East Valley Diabetes & Endocrinology; 🇺🇸 Gilbert, Arizona, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Sparrow Clinical Research Institute; 🇺🇸 Lansing, Michigan, United States

Capital Area Research; 🇺🇸 Camp Hill, Pennsylvania, United States

Wellness Clinical Research Associates; 🇺🇸 McKinney, Texas, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

TidalHealth Peninsula Regional, Inc.; 🇺🇸 Salisbury, Maryland, United States

Summit Research Group, LLC; 🇺🇸 Stow, Ohio, United States

Spectrum Medical, Inc.; 🇺🇸 Danville, Virginia, United States

Oakland Medical Research Center; 🇺🇸 Troy, Michigan, United States

Northwest Houston Heart Center; 🇺🇸 Tomball, Texas, United States

Triad Internal Medicine; 🇺🇸 Asheboro, North Carolina, United States

Wilmington Health Associates; 🇺🇸 Wilmington, North Carolina, United States

Diabetes and Thyroid Center of Fort Worth; 🇺🇸 Fort Worth, Texas, United States

Maryland Cardiovascular Specialists; 🇺🇸 Baltimore, Maryland, United States

Metabolic and Atherosclerosis Research Center; 🇺🇸 Cincinnati, Ohio, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Juno Research, LLC - Medical Center Office; 🇺🇸 Houston, Texas, United States

DM Clinical Research; 🇺🇸 Houston, Texas, United States

Evanston Premier Healthcare Research LLC; 🇺🇸 Skokie, Illinois, United States

North Georgia Clinical Research; 🇺🇸 Woodstock, Georgia, United States

Cardiovascular Research of Northwest Indiana, LLC; 🇺🇸 Munster, Indiana, United States

CentraCare Heart & Vascular Center; 🇺🇸 Saint Cloud, Minnesota, United States

North Mississippi Medical Center; 🇺🇸 Tupelo, Mississippi, United States

McClaren Bay Heart and Vascular; 🇺🇸 Bay City, Michigan, United States

Novant Health Heart and Vascular Institute; 🇺🇸 Charlotte, North Carolina, United States

Alpine Research Organization, Inc.; 🇺🇸 Clinton, Utah, United States

Amarillo Heart Clinical Research Institute, Inc; 🇺🇸 Amarillo, Texas, United States

Cardiovascular Research of Knoxville; 🇺🇸 Powell, Tennessee, United States

Chattanooga Research & Medicine, PLLC; 🇺🇸 Chattanooga, Tennessee, United States

Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc; 🇺🇸 Rapid City, South Dakota, United States

South Texas Clinical Research; 🇺🇸 Corpus Christi, Texas, United States

St. Louis Heart and Vascular Cardiology; 🇺🇸 Saint Louis, Missouri, United States

Cary Research Group, LLC; 🇺🇸 Cary, North Carolina, United States

NSC Research; 🇺🇸 Johns Creek, Georgia, United States

Horizon Research Group of Opelousas; 🇺🇸 Eunice, Louisiana, United States