Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol

Hypercholesterolemia Clinical Trial

Official title:

A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959971
• Other study ID #: PDY13670
• Secondary ID: U1111-1141-4567
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2013
• Last updated: April 28, 2017
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).

Secondary Objectives:

To assess the effects of SC doses of alirocumab on:

• Various parameters of the metabolism and turnover in plasma of different lipoproteins

• Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a))

• Lipoprotein particle size profile

• PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.

Description:

Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

Generally healthy; LDL-C level in serum or plasma = 100 mg/dL and < 190 mg/dL at Screening.

Exclusion criteria:

• LDL-C = 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.

• Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• alirocumab
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
• Placebo
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
United States	Investigational Site Number 840001	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Reyes-Soffer G, Pavlyha M, Ngai C, Thomas T, Holleran S, Ramakrishnan R, Karmally W, Nandakumar R, Fontanez N, Obunike J, Marcovina SM, Lichtenstein AH, Matthan NR, Matta J, Maroccia M, Becue F, Poitiers F, Swanson B, Cowan L, Sasiela WJ, Surks HK, Ginsbe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment		baseline and at 12 days after last dose of alirocumab
Secondary	Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL)		baseline and at 12 days after last dose of alirocumab
Secondary	Change in post-heparin hepatic lipase and lipoprotein lipase activities		baseline and at 2 days after last dose of alirocumab
Secondary	Change in lipids and apolipoproteins in plasma lipids panel		baseline and at 2 days and at 11 days after last dose of alirocumab
Secondary	Assessment of Lipoprotein particle size profiles		baseline and at 2 days and at 11 days after last dose of alirocumab
Secondary	Assessment of serum concentrations of PCSK9		baseline and up to 2 weeks after last dose of alirocumab
Secondary	Assessment of safety parameters (clinical laboratory, ECG, vital signs)		up to 10 weeks after last dose of alirocumab
Secondary	Assessment of the serum concentration of alirocumab		baseline and up to 2 weeks after last dose of alirocumab
Secondary	Assessment of the serum concentration of anti-alirocumab antibodies		baseline and up to 10 weeks after last dose of alirocumab