Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Phase 2

Completed

• Conditions: Dyslipidemia; Hypertriglyceridemia; Hypercholesterolemia
• Interventions: Drug: CAT-2003; Drug: Placebo; Drug: Statin

• Registration Number: NCT01912560
• Lead Sponsor: Catabasis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Disposition First Submitted: 2015-02-24
• Disposition First Submitted QC: 2015-02-24
• Disposition First Posted: 2015-03-17
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Between 18 and 69 years at Screening
• Hypertriglyceridemia (TG ≥ 200 mg/dL and < 500 mg/dL and non-HDL-C ≥ 100 mg/dL and < 220 mg/dL) OR
• Hypercholesterolemia (LDL-C ≥ 100 mg/dL and < 190 mg/dL and TG value < 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.
• Body mass index (BMI) ≤ 45 kg/m2

Exclusion Criteria

• History of any major cardiovascular event within 6 months of Screening
• Type I diabetes mellitus
• Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
• Any statin at the highest approved dose
• Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
• Active peptic ulcer disease or a history of muscle disease or myopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAT-2003 or Placebo Dose 3	CAT-2003	Daily for 28 days in patients with moderate hypertriglyceridemia
CAT-2003 or Placebo Dose 1	Placebo	Daily for 28 days in patients with moderate hypertriglyceridemia
CAT-2003 or Placebo Dose 2	Placebo	Daily for 28 days in patients with moderate hypertriglyceridemia
CAT-2003 or Placebo Dose 3	Placebo	Daily for 28 days in patients with moderate hypertriglyceridemia
CAT-2003 or Placebo Dose 4	CAT-2003	Daily for 28 days in patients with hypercholesterolemia who are on a statin
CAT-2003 or Placebo Dose 4	Placebo	Daily for 28 days in patients with hypercholesterolemia who are on a statin
CAT-2003 or Placebo Dose 1	CAT-2003	Daily for 28 days in patients with moderate hypertriglyceridemia
CAT-2003 or Placebo Dose 2	CAT-2003	Daily for 28 days in patients with moderate hypertriglyceridemia
CAT-2003 or Placebo Dose 4	Statin	Daily for 28 days in patients with hypercholesterolemia who are on a statin

Primary Outcome Measures

Name	Time	Method
Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia	4 weeks
Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia	4 weeks

Secondary Outcome Measures

Name	Time	Method
Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol	4 weeks
Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia	4 weeks
Frequency of adverse events	4 weeks	Safety and tolerability will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.