This trial is active, not recruiting.

Condition hypercholesterolemia
Treatment regn727 (sar236553)
Phase phase 2
Sponsor Regeneron Pharmaceuticals
Collaborator Sanofi
Start date March 2012
End date December 2016
Trial size 58 participants
Trial identifier NCT01576484, R727-CL-1032


This is a phase 2, open-label extension study to assess the long-term safety and efficacy of REGN727 (SAR236553) administered by subcutaneous (SC) injection in patients previously participating in the R727-CL-1003 study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
regn727 (sar236553)
REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody

Primary Outcomes

Incidence of AEs from baseline to end of study
time frame: Baseline (Day 1) to week 218 (End of study)

Secondary Outcomes

Percent change in LDL-C: Baseline to weeks 12, 24, 52 and 218
time frame: Baseline (Day 1) to weeks 12, 24, 52 and 218 (End of study)
Changes in other lipids and other lipoproteins
time frame: Baseline (Day 1) and week 218 (End of study)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: Key Inclusion Criteria 1. Prior participation in and the successful completion of the R727-CL-1003 study. 2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study 3. A negative urine pregnancy at the screening/baseline visit for women of childbearing potential Exclusion Criteria: Key Exclusion Criteria 1. Reported a drug-related SAE or drug-related clinical or laboratory AE in the R727-CL-1003 study that resulted in early termination or withdrawal 2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient 3. LDL apheresis within 12 months before the screening/baseline visit

Additional Information

Official title A Phase 2, Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 Administered by Subcutaneous Injection in Patients With Heterozygous Familial Hypercholesterolemia
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.