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

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ClinicalTrials.gov Identifier: NCT06005597
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
NewAmsterdam Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Hypercholesterolemia Familial Hypercholesterolemia ASCVD High Cholesterol Combination Product: Combination Therapy Drug: Monotherapy obicetrapib Drug: Monotherapy ezetimibe Other: Combination Therapy placebo Other: Obicetrapib Placebo Other: Ezetimibe Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo-controlled, double blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: placebo tablets made to resemble active; placebo capsule made to resemble active
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2024
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination Therapy
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
 Combination Product: Combination Therapy
tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Other Names:
  • Cholesteryl ester transfer protein (CETP) inhibitor
  • obicetrapib
  • ezetimibe

Other: Obicetrapib Placebo
tablet; no active ingredient

Other: Ezetimibe Placebo
capsule; no active ingredient
Experimental: Monotherapy obicetrapib
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
 Drug: Monotherapy obicetrapib
tablet; 10mg obicetrapib
Other Name: CETP inhibitor

Other: Combination Therapy placebo
tablet; no active ingredient

Other: Ezetimibe Placebo
capsule; no active ingredient
Active Comparator: Monotherapy ezetimibe
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
 Drug: Monotherapy ezetimibe
capsule; 10mg ezetimibe

Other: Combination Therapy placebo
tablet; no active ingredient

Other: Obicetrapib Placebo
tablet; no active ingredient
Placebo Comparator: Placebo
once-daily placebo tablets (2), placebo capsule
 Other: Combination Therapy placebo
tablet; no active ingredient

Other: Obicetrapib Placebo
tablet; no active ingredient

Other: Ezetimibe Placebo
capsule; no active ingredient


Outcome Measures
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Primary Outcome Measures :
  1. Effect of combination therapy compared to placebo on LDL-C [ Time Frame: 84-Days ]
    Percent Change in LDL-C

  2. Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C [ Time Frame: 84-Days ]
    Percent Change in LDL-C

  3. Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C [ Time Frame: 84-Days ]
    Percent Change in LDL-C


Secondary Outcome Measures :
  1. Effect of combination therapy compared to placebo on non-HDL-C [ Time Frame: 84-Days ]
    Percent Change in non-HDL-C

  2. Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C [ Time Frame: 84-Days ]
    Percent Change in non-HDL-C

  3. Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C [ Time Frame: 84-Days ]
    Percent Change in non-HDL-C

  4. Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB) [ Time Frame: 84-Days ]
    Percent Change in ApoB

  5. Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB [ Time Frame: 84-Days ]
    Percent Change in ApoB

  6. Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB [ Time Frame: 84-Days ]
    Percent Change in ApoB


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005597


Contacts
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Contact: Kirsten Bowman 1-513-205-1109 k.bowman@medpace.com

Locations
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Sponsors and Collaborators
NewAmsterdam Pharma
Investigators
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Study Director: Marc Ditmarsch, MD NewAmsterdam Pharma
More Information
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Responsible Party: NewAmsterdam Pharma
ClinicalTrials.gov Identifier: NCT06005597    
Other Study ID Numbers: OBEZ-301
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NewAmsterdam Pharma:
obicetrapib
statin
LDL-C
cholesterol
atherosclerosis
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
 Genetic Diseases, Inborn
Hyperlipoproteinemias
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents