A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins

Phase 3

Withdrawn

• Conditions: high cholesterol; primary hypercholesterolemia; 10027424; 10013317; 10003216

• Registration Number: NL-OMON39721
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

Patients with primary hypercholesterolemia (familiaal of niet familiaal) with moderate, high or very high CV risk and a history of statin intolerance
*** Definition of statin intolerance: Inability to tolerate at least 2 previous statins at the lowest approved daily dose due to skeletal muscle-related symptoms, other than those due to strain or trauma, such as pain, aches, weakness, or cramping, that began or increased during statin therapy and stopped when statin therapy was discontinued.

Exclusion Criteria

- Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk (as defined in section 4.2) at the screening visit (week -7)
- Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk (as defined in section 4.2) at the screening visit (week -7)
- diagnosis of fibromyalgia, history of severe neuropathic pain, history of reumatological disease, history of myalgia or myopathy, history of seizure disorder, history of transplant surgery
- presence of clinically significant uncontrolled endocrine disease known to influence serum lipids
- known loss of function of PCSK9 (genetic mutation)
- known homozygous FH
- < 18 years or legal age
- known HIV positivity
- previous participation in any clinical trial of REGN727 or SAR236553

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is the percent change in calculated LDL-C from<br /><br>baseline to week 24</p><br>