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HypercholesterolemiaPhase 2NCT01592240

Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

A Phase 2 study testing PBO, 200mg PF-04950615 (RN316) and 300mg PF-04950615 (RN316) in people with Hypercholesterolemia, run by Pfizer at 74 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia
What is being tested?
PBO, 200mg PF-04950615 (RN316) and 300mg PF-04950615 (RN316)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
74 sitesUnited States
Study dates
Jul 2012to May 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial.
  • Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1:
  • Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);
  • Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).
  • Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.

Who cannot join

  • Participation in other studies within 3 months before the current study begins and/or during study participation.
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product.
  • History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV.
  • Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
  • Poorly controlled hypertension.

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • New Mexico Clinical Research and Osteoporosis Center, Inc.

    Albuquerque, New Mexico, 87106

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Radiant Research, Inc.

    Atlanta, Georgia, 30328

  • Maine Research Associates

    Auburn, Maine, 04210

  • Fox Valley Clinical Research Center, LLC

    Aurora, Illinois, 60504

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Zasa Clinical Research

    Boynton Beach, Florida, 33472

  • Radiant Research, Inc.

    Chicago, Illinois, 60654

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio, 45219

  • Sentral Clinical Research Services

    Cincinnati, Ohio, 45236

  • Sterling Research Group, LTD.

    Cincinnati, Ohio, 45246

  • Florida Health Center

    Davie, Florida, 33312

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Universal Biopharma Research Institute Inc. - Alta Family Health Clinic

    Dinuba, California, 93618

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Radiant Research, Inc.

    Edina, Minnesota, 55435

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • ActivMed Practices and Research

    Haverhill, Massachusetts, 01830

  • In Vivo Clinical Research, Inc.

    Hialeah, Florida, 33010

  • Health Care Family Rehab and Research Center

    Hialeah, Florida, 33012

  • Clinical Trials of America, Inc.

    Hickory, North Carolina, 28601

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Baylor College of Medicine - Center for Cardiovascular Disease Prevention

    Houston, Texas, 77030

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • The Office of James G. McMurray, MD

    Huntsville, Alabama, 35801

  • Protenium Clinical Research, LLC

    Hurst, Texas, 76054

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Dybedal Clinical Research Center

    Kansas City, Missouri, 64106

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Maine Research Associates

    Lewiston, Maine, 04240

  • Clinical Trials Research

    Lincoln, California, 95648

  • Aureus Research Inc.

    Little Rock, Arkansas, 72205

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Albert J. Weisbrot, M.D., Inc.

    Mason, Ohio, 45040

  • Crescent City Clinical Research Center

    Metairie, Louisiana, 70006

  • Community Research Foundation, Inc.

    Miami, Florida, 33155

  • Kendall South Medical Center, Inc.

    Miami, Florida, 33185

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • National Clinical Research- Norfolk, Inc

    Norfolk, Virginia, 23502

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • The Office of Lucita M. Cruz, MD, Inc.

    Norwalk, California, 90650

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • Omega Research Consultants, LLC

    Orlando, Florida, 32804

  • Midwest Heart & Vascular Specialists

    Overland Park, Kansas, 66209

  • DMI Research

    Pinellas Park, Florida, 33782

  • St Johns Center for Clinical Research

    Ponte Vedra, Florida, 32081

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • PMG Research of Raleigh

    Raleigh, North Carolina, 27609

  • Wake Internal Medicine Consultants

    Raleigh, North Carolina, 27612

  • National Clinical Research - Richmond, Inc.

    Richmond, Virginia, 23294

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Paragon Research Center, LLC

    San Antonio, Texas, 78205

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Radiant Research

    Santa Rosa, California, 95405

  • The Office of Bridget Bellingar, DO

    Seminole, Florida, 33774

  • Miami Research Associates

    South Miami, Florida, 33143

  • Premier Clinical Research

    Spokane, Washington, 99204

  • St. Joseph's Medical Associates

    Stockton, California, 95204

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Southwest Heart Group

    Tucson, Arizona, 85710

  • Orange County Research Center

    Tustin, California, 92780

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Ardmore Family Practice

    Winston-Salem, North Carolina, 27103

  • Clinical Trials of America, Inc.

    Winston-Salem, North Carolina, 27103

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin

To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.

Being tested
PBO, 200mg PF-04950615 (RN316), 300mg PF-04950615 (RN316), PF-04950615
Keywords
PF-04950615, RN316
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PBODrug

    Placebo Q28d

  • 200mg PF-04950615 (RN316)Drug

    Also called PF-04950615 (RN316)

    PF-04950615 200 mg, Q28d

  • 300mg PF-04950615 (RN316)Drug

    Also called PF-04950615 (RN316)

    PF-04950615 300 mg, Q28d

  • PBODrug

    Placebo, Q14d

  • PF-04950615Drug

    Also called PF-04950615 (RN316)

    PF-04950615 50mg, Q14d

  • PF-04950615Drug

    Also called PF-04950615 (RN316)

    PF-04950615 100 mg, Q14d

  • PF-04950615Drug

    Also called PF-04950615 (RN316)

    PF-04950615 150mg, Q14d

Study groups in NCT01592240
Study groupRoleWhat they receive
Q28d Dosing ArmExperimentalA total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.
Receives: Drug: PBO; Drug: 200mg PF-04950615 (RN316); Drug: 300mg PF-04950615 (RN316)
Q14d Dosing ArmExperimentalA total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.
Receives: Drug: PBO; Drug: PF-04950615

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, Week 12

Secondary outcomes (24)

  1. Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

    Measured: Baseline, Week 24

  2. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  3. Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  4. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  5. Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  6. Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  7. Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  8. Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  9. Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  10. Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  11. Change From Baseline in Total Cholesterol at Week 12 and 24

    Measured: Baseline, Week 12, 24

  12. Percent Change From Baseline in Total Cholesterol at Week 12 and 24

    Measured: Baseline, Week 12, 24

  13. Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  14. Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

    Measured: Baseline, Week 12, 24

  15. Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24

    Measured: Baseline, Week 12, 24

  16. Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24

    Measured: Baseline, Week 12, 24

  17. Change From Baseline in Triglycerides at Week 12 and 24

    Measured: Baseline, Week 12, 24

  18. Percent Change From Baseline in Triglycerides at Week 12 and 24

    Measured: Baseline, Week 12, 24

  19. Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24

    Measured: Baseline, Week 12, 24

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

    Measured: Baseline, Week 12, 24

  21. Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)

    Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.

    Measured: Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups

  22. Percentage of Participants With Injection Site Adverse Events

    Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.

    Measured: Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups

  23. Plasma Concentration of PF-04950615 at Week 12 and 24

    Measured: Week 12, 24

  24. Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)

    Measured: Week 12, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionApr 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01592240
Sponsor's protocol ID
B1481015
Other IDs
2012-001226-10
Status last verified
Oct 2017
First submitted
3 May 2012
Last updated
5 Dec 2017
Data monitoring committee
No

Publications

  • Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.

    PubMed 37994400

  • Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, Sweeney K, Kaila N, Vincent J, Bays H. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol. 2015 May 1;115(9):1212-21. doi: 10.1016/j.amjcard.2015.02.006. Epub 2015 Feb 12.

    PubMed 25784512

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PBO, 200mg PF-04950615 (RN316) and 300mg PF-04950615 (RN316) in people with Hypercholesterolemia, run by Pfizer at 74 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01592240, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.

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