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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

Tracking Information
First Submitted Date  ICMJE August 15, 2023
First Posted Date  ICMJE August 22, 2023
Last Update Posted Date May 3, 2024
Actual Study Start Date  ICMJE March 1, 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2023)
  • Effect of combination therapy compared to placebo on LDL-C [ Time Frame: 84-Days ]
    Percent Change in LDL-C
  • Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C [ Time Frame: 84-Days ]
    Percent Change in LDL-C
  • Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C [ Time Frame: 84-Days ]
    Percent Change in LDL-C
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2023)
  • Effect of combination therapy compared to placebo on non-HDL-C [ Time Frame: 84-Days ]
    Percent Change in non-HDL-C
  • 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
  • Effect of combination therapy compared to obicetrapib 10 mg monotherapy on non-HDL-C [ Time Frame: 84-Days ]
    Percent Change in non-HDL-C
  • Effect of combination therapy compared to placebo on Apolipoprotein B (ApoB) [ Time Frame: 84-Days ]
    Percent Change in ApoB
  • Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB [ Time Frame: 84-Days ]
    Percent Change in ApoB
  • Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB [ Time Frame: 84-Days ]
    Percent Change in ApoB
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Dyslipidemias
  • Hypercholesterolemia
  • Familial Hypercholesterolemia
  • ASCVD
  • High Cholesterol
Intervention  ICMJE
  • Combination Product: Combination Therapy
    tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
    Other Names:
    • Cholesteryl ester transfer protein (CETP) inhibitor
    • obicetrapib
    • ezetimibe
  • Drug: Monotherapy obicetrapib
    tablet; 10mg obicetrapib
    Other Name: CETP inhibitor
  • Drug: Monotherapy ezetimibe
    capsule; 10mg ezetimibe
  • Other: Combination Therapy placebo
    tablet; no active ingredient
  • Other: Obicetrapib Placebo
    tablet; no active ingredient
  • Other: Ezetimibe Placebo
    capsule; no active ingredient
Study Arms  ICMJE
  • Experimental: Combination Therapy
    once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
    Interventions:
    • Combination Product: Combination Therapy
    • Other: Obicetrapib Placebo
    • Other: Ezetimibe Placebo
  • Experimental: Monotherapy obicetrapib
    once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
    Interventions:
    • Drug: Monotherapy obicetrapib
    • Other: Combination Therapy placebo
    • Other: Ezetimibe Placebo
  • Active Comparator: Monotherapy ezetimibe
    once-daily ezetimibe 10 mg capsule, 2 placebo tablets
    Interventions:
    • Drug: Monotherapy ezetimibe
    • Other: Combination Therapy placebo
    • Other: Obicetrapib Placebo
  • Placebo Comparator: Placebo
    once-daily placebo tablets (2), placebo capsule
    Interventions:
    • Other: Combination Therapy placebo
    • Other: Obicetrapib Placebo
    • Other: Ezetimibe Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2023)		 400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kirsten Bowman 1-513-205-1109 k.bowman@medpace.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06005597
Other Study ID Numbers  ICMJE OBEZ-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party NewAmsterdam Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NewAmsterdam Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marc Ditmarsch, MD NewAmsterdam Pharma
PRS Account NewAmsterdam Pharma
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP