A study to assess the efficacy, safety and tolerability of PF-04950615 following monthly and twice monthly injection dosing for six months in subjects on a statin with high cholesterol.

Phase 1

Active, not recruiting

• Conditions: Hyperlipidemia; MedDRA version: 14.1Level: LLTClassification code 10020667Term: HyperlipidemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001226-10-GB
• Lead Sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Study Completion: 2013-05-30
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Males and females aged =18 years
2. Subjects should be receiving a stable dose (at least 6 weeks) of any statin in the participating country and there should be no change in the dose of statin for the duration of this trial. Subjects are allowed to take lipid lowering drugs other than a statin (eg, fibrates, cholesterol absorption inhibitor, niacin, omega-3 fatty acids) if initiated, and if the dose has remained unchanged for at least 6 weeks prior to randomization (Day 1) and no dose adjustment for these medicines will be allowed for the duration of this trial.
3. 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 =80 mg/dL (2.31 mmol/L);
-Fasting TG = 400 mg/dL (4.52 mmol/L).
4. Subject’s fasting LDL-cholesterol must =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.
5. Willing and able to comply with scheduled visits.
6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
8. Females of childbearing potential must be using 2 highly effective methods of contraception and must agree to continue highly effective contraception for up to 63 days after the last dose of investigational drug administration.
9. Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
-Have undergone hysterectomy or bilateral oophorectomy;
-Have medically confirmed ovarian failure or
-Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation of estrogen levels may be indicated when in doubt.
10. Male and female subjects of childbearing potential must agree to use 2 highly effective methods of contraception throughout the study and for at least 63 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the
opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 245
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion Criteria

1.Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
2.Participation in other studies within 3 months before the current study begins and/or during study participation
3.Other 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.
4.Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception.
Exclusion Criteria Related to General Health
1.History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months.
2.Subjects with congestive heart failure (CHF), NYHA functional classes III or IV
3. Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%). Subjects who have diabetes mellitus and are controlled on stable doses of anti-diabetic medication may be entered into the trial.
4.Poorly controlled hypertension (uncontrolled hypertension is defined as the average of two systolic blood pressure measurements greater than 160 mm Hg or the average of two diastolic blood pressure measurements greater than 100 mm Hg, even with treatment).
5.Plans to donate blood during the study.
6.Past or current history of alcoholism or drug addiction according to DSM IV criteria, use of any recreational drugs within 12 months prior to Day 1.
7.History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision).
8.Medical history of positive testing for HIV.
9.Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal
systems or confound the interpretation of the study results.
Exclusion Criteria Related to Medication
1.Subjects with prior exposure to PF-04950615 and who test positive for anti-drug antibodies at baseline
2.Subjects who have initiated lipid-lowering herbs or supplements within 30 days of Day1, and/or who are not on stable doses of such lipid-lowering herbs or supplements.
3.Initiation of or change in non lipid-lowering prescription drugs, herbal medicine or supplements within 30 days of Day 1 (exception: initiation or change in multivitamins used for general health purposes are acceptable. Adjustments to hypertension medications to meet eligibility are permitted.
4.Subjects on systemic corticosteroids (ie, oral, IV or IM) or mineralocorticoid replacement.
5.Subjects taking prescription medications that are contraindicated with the use of statins. Refer to statin product labels for these medications.
6.Treatment with an investigational drug within 45 days or 5 half-lives (whichever is longer) of Day 1.
7.Treatment with a marketed monoclonal antibody within 6 months or 5 half-lives (whichever is longer) of Day 1.
8.History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibodies (eg, Enbrel which is the Fc portion of an antibody or Lucentis which is

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified