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Completed

NCT Number: NCT01588496

Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

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Key information

Conditions

Homozygous Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Research Site, Brussels, Belgium

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About this study

Study Masking:

Part A: Open Label Part B: Double Blind

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females ≥ 12 to ≤ 80 years of age
  • Diagnosis of homozygous familial hypercholesterolemia
  • Stable lipid-lowering therapies for at least 4 weeks
  • LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
  • Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
  • Bodyweight of ≥ 40 kg at screening.

Exclusion criteria

  • LDL or plasma apheresis within 8 weeks prior to randomization
  • New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
  • Planned cardiac surgery or revascularization
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension

Treatment and study plan

Evolocumab

Biological

Administered by subcutaneous injection

Other names: AMG 145, Repatha

Placebo

Drug

Administered by subcutaneous injection

Primary outcomes

  1. Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and Week 12

    LDL-C was quantified using the ultracentrifugation method.

  2. Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and Week 12

    LDL-C was quantified using the ultracentrifugation method.

Secondary outcomes

  1. Part A: Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

    LDL-C was quantified using the ultracentrifugation method.

  2. Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

    Time frame: Baseline and Week 12

  3. Part A: Percent Change From Baseline in Apolipoprotein B at Week 12

    Time frame: Baseline and Week 12

  4. Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12

    Time frame: Baseline and Week 12

  5. Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12

    Time frame: Baseline and Week 12

  6. Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12

    Time frame: Baseline and Week 12

    LDL-C was quantified using the ultracentrifugation method.

  7. Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12

    Time frame: Baseline and Week 12

  8. Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12

    Time frame: Baseline and Weeks 6 and 12

    LDL-C was quantified using the ultracentrifugation method.

  9. Part B: Percent Change From Baseline in Apolipoprotein B at Week 12

    Time frame: Baseline and Week 12

  10. Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12

    Time frame: Baseline and Weeks 6 and 12

  11. Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12

    Time frame: Baseline and Week 12

  12. Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12

    Time frame: Baseline and Weeks 6 and 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

Acronym: TESLA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 1, 2012
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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