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Completed

NCT Number: NCT02135029

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Medical Arts Health Research Group, Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hyperlipidemia
  • Statin Intolerant
  • Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion criteria

  • Pregnant or breastfeeding females
  • Cardiovascular or cerebrovascular event or procedure within 90 days
  • Severe or life-threatening adverse events with past use of statins
  • Poorly controlled hypertension

Treatment and study plan

Bococizumab (PF-04950615;RN316)

Drug

150 mg every 2 weeks by subcutaneous injection for 24 weeks

atorvastatin

Drug

Atorvastatin PO QD

Placebo for Bococizumab (PF-04950615;RN316)

Other

150 mg every 2 weeks by subcutaneous injection for 24 weeks

Placebo for atorvastatin

Other

PO QD

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  2. Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  3. Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  4. Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  5. Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  6. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24

    Time frame: Baseline, Week 24

  7. Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  8. Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  9. Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  10. Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  11. Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline, Week 12

  12. Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

    Time frame: Baseline, Week 12

  13. Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Time frame: Baseline, Week 12

  14. Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

    Time frame: Baseline, Week 12

  15. Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12

    Time frame: Baseline, Week 12

  16. Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12

    Time frame: Baseline, Week 12

  17. Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12

    Time frame: Baseline, Week 12

  18. Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24

    Time frame: Baseline, Week 12, 24

  19. Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24

    Time frame: Baseline, Week 12, 24

  20. Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24

    Time frame: Week 12, 24

  21. Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24

    Time frame: Week 12, 24

  22. Plasma PF-04950615 Concentrations at Weeks 12 and 24

    Time frame: Week 12 and 24

    Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter [mcg/mL]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.

  23. Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations

    Time frame: Baseline (Day 1) up to Week 30

  24. Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

    Time frame: Baseline up to Week 30

    Participants with at least one positive ADA titer greater than or equal to (>=) 6.23 or positive nAb titer >=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

  25. Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively

    Time frame: Week 4, 12, 24 and 30 (Follow-up)

    Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

  26. Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations

    Time frame: Baseline (Day 1) up to Week 30

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins

Acronym: SPIRE-SI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 9, 2014
Registry last updated
Dec 14, 2017

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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