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The trial is taking place at:
S

South Texas Clinical Research | Corpus Christi, TX

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

N

NewAmsterdam Pharma

Status and phase

Active, not recruiting
Phase 3

Conditions

Dyslipidemias
Hypercholesterolemia
High Cholesterol
ASCVD
Familial Hypercholesterolemia

Treatments

Other: Combination Therapy placebo
Drug: Monotherapy ezetimibe
Other: Obicetrapib Placebo
Combination Product: Combination Therapy
Drug: Monotherapy obicetrapib
Other: Ezetimibe Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06005597
OBEZ-301

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

400 participants in 4 patient groups, including a placebo group

Combination Therapy
Experimental group
Description:
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Treatment:
Other: Ezetimibe Placebo
Combination Product: Combination Therapy
Other: Obicetrapib Placebo
Monotherapy obicetrapib
Experimental group
Description:
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Treatment:
Other: Ezetimibe Placebo
Drug: Monotherapy obicetrapib
Other: Combination Therapy placebo
Monotherapy ezetimibe
Active Comparator group
Description:
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Treatment:
Other: Obicetrapib Placebo
Drug: Monotherapy ezetimibe
Other: Combination Therapy placebo
Placebo
Placebo Comparator group
Description:
once-daily placebo tablets (2), placebo capsule
Treatment:
Other: Ezetimibe Placebo
Other: Obicetrapib Placebo
Other: Combination Therapy placebo

Trial contacts and locations

46

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Central trial contact

Kirsten Bowman

Data sourced from clinicaltrials.gov

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