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REGN727

Phase 1

Healthy | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Jan 27, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

REGN727 · 3 trials · 3 indications

Phase 1 3
NCT01161082Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant AtorvastatinHypercholesterolemia
COMPLETED72 Analytics
NCT01074372Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy VolunteersHealthy Volunteers
COMPLETED32 Analytics
NCT01026597Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy VolunteersHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
Hypercholesterolemia
NCT0116108272
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PHASE1COMPLETED
Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers
Healthy Volunteers
NCT0107437232
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PHASE1COMPLETED
Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers
Healthy
NCT0102659740
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Study Endpoints

Primary Endpoints

The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.
visit 4 (day 1) to visit 16 (day 148)
The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106
106 days
The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106.
106 days

Secondary Endpoints

To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin
Visit 4 (Day 1) to Visit 16 (Day 148)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1 with atorvastatinEXPERIMENTALDose 1 versus placebo
Group 2 with atorvastatinEXPERIMENTALDose 1 versus placebo
Group 3 with atorvastatinEXPERIMENTALDose 2 versus placebo
Group 4 with atorvastatinEXPERIMENTALDose 2 versus placebo
Group 5 with atorvastatinEXPERIMENTALDose 3 versus placebo
Group 6 with atorvastatinEXPERIMENTALDose 3 versus placebo
Group 7 without atorvastatinEXPERIMENTALDose 3 versus placebo
Group 8 with atorvastatinEXPERIMENTALDose4 versus placebo
Cohort 1EXPERIMENTALDose 1 versus placebo
Cohort 2EXPERIMENTALDose 2 versus placebo
Cohort 3EXPERIMENTALDose 3 versus placebo
Cohort 4EXPERIMENTALDose 4 versus placebo
cohort 5EXPERIMENTALDose 5 versus placebo

Interventions

NameTypeDescription
REGN727(SAR236553)DRUGsubcutaneous
REGN727DRUG4 cohorts (dose 1, 2, 3, 4)
PlaceboDRUG4 cohorts (dose 1, 2, 3, 4)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria * Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen * Body mass index between 18.0 and 35.0 kg/m2, inclusive * For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test...

Countries:United States
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Frequently asked questions about REGN727

What is REGN727 used for?

REGN727 is an investigational small molecule being studied in healthy volunteers and in patients with hypercholesterolemia. It is in Phase 1 clinical development by Regeneron Pharmaceuticals, Inc. (REGN). The drug has been evaluated in early-stage trials for safety and tolerability.

Who makes REGN727?

REGN727 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The drug is currently in Phase 1 clinical development.

What phase is REGN727 in?

REGN727 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed to assess its safety and tolerability in healthy volunteers and in patients with hypercholesterolemia.

What clinical trials is REGN727 in?

REGN727 has been studied in three completed Phase 1 trials. NCT01026597 and NCT01074372 assessed ascending doses in healthy volunteers. NCT01161082 evaluated ascending multi-doses with and without concomitant atorvastatin in patients with hypercholesterolemia. All trials were conducted in the United States.

Is REGN727 the same as SAR236553?

REGN727 is also known as SAR236553. Clinical trial titles refer to REGN727(SAR236553), indicating that both names refer to the same drug candidate being developed by Regeneron Pharmaceuticals.