Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | December 2013 |
| End Date: | May 2015 |
A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol
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.
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.
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.
weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a
follow up period of 8 weeks.
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.
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