Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

NCT02055976 | Completed Phase 2 Results

• 1 other identifier: B1481036
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.

Conditions

Hypercholesterolemia

Keywords

PF-04950615; Japan

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85

  LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.

  Baseline, Day 85

• Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113

  LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.

  Baseline, Day 113

Secondary Outcomes (46)

• Low Density Lipoprotein-Cholesterol (LDL-C)

  Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

• Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113

  Baseline, Day 85, 113

• Total Cholesterol (TC)

  Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169

• Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113

  Baseline, Day 85, 113

• Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113

  Baseline, Day 85, 113

Study Arms (2)

Population A

EXPERIMENTAL

A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.

Drug: Bococizumab (PF-04950615;RN316); Drug: Placebo; Drug: Ezetimibe

Population B

EXPERIMENTAL

A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.

Drug: Bococizumab (PF-04950615;RN316); Drug: Placebo

Interventions

Bococizumab (PF-04950615;RN316) DRUG

Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week

Population A

Placebo DRUG

Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week

Population A

Ezetimibe DRUG

Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)

Population A

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).
• Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).

You may not qualify if:

• Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
• Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
• Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Maebashi Hirosegawa Clinic

Maebashi, Gunma, 371-0022, Japan

Location

Yokohama Minoru Clinic

Yokohama, Kanagawa, 232-0064, Japan

Location

Heishinkai Medical Group Incorporated OCROM Clinic

Suita, Osaka, 565-0853, Japan

Location

Meiwa Hospital

Chiyoda-ku, Tokyo, 101-0041, Japan

Location

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Heishinkai Medical Group Incorporated ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0022, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan

Location

Oda Clinic

Shinjuku-ku, Tokyo, 169-0072, Japan

Location

Sekino Hospital

Toshima-ku, Tokyo, 171-0014, Japan

Location

Related Publications (3)

• 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.

  PMID: 37994400 DERIVED

• Yokote K, Suzuki A, Li Y, Matsuoka N, Teramoto T. Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects . Int J Clin Pharmacol Ther. 2019 Dec;57(12):575-589. doi: 10.5414/CP203418.

  PMID: 31549625 DERIVED

• Yokote K, Kanada S, Matsuoka O, Sekino H, Imai K, Tabira J, Matsuoka N, Chaudhuri S, Teramoto T. Efficacy and Safety of Bococizumab (RN316/PF-04950615), a Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, in Hypercholesterolemic Japanese Subjects Receiving a Stable Dose of Atorvastatin or Treatment-Naive - Results From a Randomized, Placebo-Controlled, Dose-Ranging Study. Circ J. 2017 Sep 25;81(10):1496-1505. doi: 10.1253/circj.CJ-16-1310. Epub 2017 May 23.

  PMID: 28539539 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

bococizumab; Ezetimibe

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: February 5, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 8, 2019
• Results First Posted: February 8, 2019

Record last verified: 2018-09

Locations

JP (9)