NCT01912560

Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Catabasis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.

Conditions

• Dyslipidemia
• Hypercholesterolemia
• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	CAT-2003
DRUG	Placebo
DRUG	Statin	All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-07-31
• Last updated: 2016-07-28

Locations

14 sites across 2 countries: United States, Canada