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NCT06005597 Clinical Trial

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

Hypercholesterolemia Clinical Trial

— TANDEM  

Official title:
A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06005597
Other study ID # OBEZ-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 1, 2024
Est. completion date November 2024

Study information
Verified date March 2024
Source NewAmsterdam Pharma
Contact Kirsten Bowman
Phone 1-513-205-1109
Email k.bowman@medpace.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 400
Est. completion date November 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Combination Therapy
tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Drug:
• Monotherapy obicetrapib
tablet; 10mg obicetrapib
• Monotherapy ezetimibe
capsule; 10mg ezetimibe
Other:
• Combination Therapy placebo
tablet; no active ingredient
• Obicetrapib Placebo
tablet; no active ingredient
• Ezetimibe Placebo
capsule; no active ingredient

Locations
Country Name City State
United States Amarillo Heart Clinical Research Institute, Inc Amarillo Texas
United States PharmaTex Research, LLC Amarillo Texas
United States Triad Internal Medicine Asheboro North Carolina
United States Maryland Cardiovascular Specialists Baltimore Maryland
United States McClaren Bay Heart and Vascular Bay City Michigan
United States Grace Research, LLC - Bossier City, LA Bossier City Louisiana
United States Northern Pines Health Center Buckley Michigan
United States Capital Area Research Camp Hill Pennsylvania
United States Cary Research Group, LLC Cary North Carolina
United States Novant Health Clinical Research, LLC Charlotte North Carolina
United States Novant Health Heart and Vascular Institute Charlotte North Carolina
United States Chattanooga Research & Medicine, PLLC Chattanooga Tennessee
United States Metabolic and Atherosclerosis Research Center Cincinnati Ohio
United States Alpine Research Organization, Inc. Clinton Utah
United States Centricity Research - Columbus Columbus Georgia
United States South Texas Clinical Research Corpus Christi Texas
United States Spectrum Medical, Inc. Danville Virginia
United States Horizon Research Group of Opelousas Eunice Louisiana
United States Diabetes and Thyroid Center of Fort Worth Fort Worth Texas
United States Center for Advanced Research and Education Gainesville Georgia
United States East Valley Diabetes & Endocrinology Gilbert Arizona
United States Baylor College of Medicine Houston Texas
United States DM Clinical Research Houston Texas
United States Juno Research, LLC Houston Texas
United States Juno Research, LLC - Medical Center Office Houston Texas
United States Midwest Institute for Clinical Research Indianapolis Indiana
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States NSC Research Johns Creek Georgia
United States Sparrow Clinical Research Institute Lansing Michigan
United States Wellness Clinical Research Associates McKinney Texas
United States Lucas Research, Inc Morehead City North Carolina
United States Burke Primary Care Morganton North Carolina
United States Cardiovascular Research of Northwest Indiana, LLC Munster Indiana
United States Progressive Medical Research Port Orange Florida
United States Cardiovascular Research of Knoxville Powell Tennessee
United States Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc Rapid City South Dakota
United States CentraCare Heart & Vascular Center Saint Cloud Minnesota
United States St. Louis Heart and Vascular Cardiology Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States TidalHealth Peninsula Regional, Inc. Salisbury Maryland
United States Evanston Premier Healthcare Research LLC Skokie Illinois
United States Summit Research Group, LLC Stow Ohio
United States Hampton Roads Center for Clinical Research Suffolk Virginia
United States Northwest Houston Heart Center Tomball Texas
United States Oakland Medical Research Center Troy Michigan
United States North Mississippi Medical Center Tupelo Mississippi
United States Wilmington Health Associates Wilmington North Carolina
United States North Georgia Clinical Research Woodstock Georgia

Sponsors (1)
Lead Sponsor Collaborator
NewAmsterdam Pharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of combination therapy compared to placebo on LDL-C Percent Change in LDL-C 84-Days
Primary Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C Percent Change in LDL-C 84-Days
Primary Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C Percent Change in LDL-C 84-Days
Secondary Effect of combination therapy compared to placebo on non-HDL-C Percent Change in non-HDL-C 84-Days
Secondary Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C Percent Change in non-HDL-C 84-Days
Secondary Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C Percent Change in non-HDL-C 84-Days
Secondary Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB) Percent Change in ApoB 84-Days
Secondary Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB Percent Change in ApoB 84-Days
Secondary Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB Percent Change in ApoB 84-Days
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