Clinical Trial: Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia
Brief Summary: The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH).
Detailed Summary:
Sponsor: Madrigal Pharmaceuticals, Inc.
Current Primary Outcome: Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 12 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability of MGL-3196 based on Adverse Events and Changes in Laboratory Values [ Time Frame: 12 Weeks ]
- Mean percent change from baseline on selected lipid parameters [ Time Frame: 12 Weeks ]Non-high-density lipoprotein cholesterol (non-HDL-C),Apolipoprotein B (ApoB), Total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C) ratio, Triglycerides,Lipoprotein(a), Apolipoprotein A1 (ApoA1)/ApoB ratio, and Lipoprotein particle assessment
Original Secondary Outcome: Same as current
Information By: Madrigal Pharmaceuticals, Inc.
Dates:
Date Received: January 30, 2017
Date Started: February 1, 2017
Date Completion: October 31, 2017
Last Updated: February 8, 2017
Last Verified: February 2017
