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

Primary Purpose

Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Combination Therapy
Monotherapy obicetrapib
Monotherapy ezetimibe
Combination Therapy placebo
Obicetrapib Placebo
Ezetimibe Placebo
Sponsored by
NewAmsterdam Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring obicetrapib, statin, LDL-C, cholesterol, atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or HDL-C ≥ 100 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Combination Therapy

    Monotherapy obicetrapib

    Monotherapy ezetimibe

    Placebo

    Arm Description

    once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule

    once-daily obicetrapib 10 mg, placebo tablet, placebo capsule

    once-daily ezetimibe 10 mg capsule, 2 placebo tablets

    once-daily placebo tablets (2), placebo capsule

    Outcomes

    Primary Outcome Measures

    Effect of combination therapy compared to placebo on LDL-C
    Percent Change in LDL-C
    Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C
    Percent Change in LDL-C
    Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C
    Percent Change in LDL-C

    Secondary Outcome Measures

    Effect of combination therapy compared to placebo on non-HDL-C
    Percent Change in non-HDL-C
    Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C
    Percent Change in non-HDL-C
    Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C
    Percent Change in non-HDL-C
    Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB)
    Percent Change in ApoB
    Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB
    Percent Change in ApoB
    Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB
    Percent Change in ApoB

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    August 22, 2023
    Sponsor
    NewAmsterdam Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06005597
    Brief Title
    Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NewAmsterdam Pharma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD, High Cholesterol
    Keywords
    obicetrapib, statin, LDL-C, cholesterol, atherosclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Placebo-controlled, double blind, randomized
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    placebo tablets made to resemble active; placebo capsule made to resemble active
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Combination Therapy
    Arm Type
    Experimental
    Arm Description
    once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
    Arm Title
    Monotherapy obicetrapib
    Arm Type
    Experimental
    Arm Description
    once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
    Arm Title
    Monotherapy ezetimibe
    Arm Type
    Active Comparator
    Arm Description
    once-daily ezetimibe 10 mg capsule, 2 placebo tablets
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    once-daily placebo tablets (2), placebo capsule
    Intervention Type
    Combination Product
    Intervention Name(s)
    Combination Therapy
    Other Intervention Name(s)
    Cholesteryl ester transfer protein (CETP) inhibitor, obicetrapib, ezetimibe
    Intervention Description
    tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
    Intervention Type
    Drug
    Intervention Name(s)
    Monotherapy obicetrapib
    Other Intervention Name(s)
    CETP inhibitor
    Intervention Description
    tablet; 10mg obicetrapib
    Intervention Type
    Drug
    Intervention Name(s)
    Monotherapy ezetimibe
    Intervention Description
    capsule; 10mg ezetimibe
    Intervention Type
    Other
    Intervention Name(s)
    Combination Therapy placebo
    Intervention Description
    tablet; no active ingredient
    Intervention Type
    Other
    Intervention Name(s)
    Obicetrapib Placebo
    Intervention Description
    tablet; no active ingredient
    Intervention Type
    Other
    Intervention Name(s)
    Ezetimibe Placebo
    Intervention Description
    capsule; no active ingredient
    Primary Outcome Measure Information:
    Title
    Effect of combination therapy compared to placebo on LDL-C
    Description
    Percent Change in LDL-C
    Time Frame
    84-Days
    Title
    Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C
    Description
    Percent Change in LDL-C
    Time Frame
    84-Days
    Title
    Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C
    Description
    Percent Change in LDL-C
    Time Frame
    84-Days
    Secondary Outcome Measure Information:
    Title
    Effect of combination therapy compared to placebo on non-HDL-C
    Description
    Percent Change in non-HDL-C
    Time Frame
    84-Days
    Title
    Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C
    Description
    Percent Change in non-HDL-C
    Time Frame
    84-Days
    Title
    Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C
    Description
    Percent Change in non-HDL-C
    Time Frame
    84-Days
    Title
    Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB)
    Description
    Percent Change in ApoB
    Time Frame
    84-Days
    Title
    Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB
    Description
    Percent Change in ApoB
    Time Frame
    84-Days
    Title
    Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB
    Description
    Percent Change in ApoB
    Time Frame
    84-Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 or HDL-C ≥ 100 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kirsten Bowman
    Phone
    1-513-205-1109
    Email
    k.bowman@medpace.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc Ditmarsch, MD
    Organizational Affiliation
    NewAmsterdam Pharma
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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