Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

NCT01912560 | Completed Phase 2

• 1 other identifier: CAT-2003-201
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 14

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.

Conditions

Dyslipidemia; Hypercholesterolemia; Hypertriglyceridemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (4)

CAT-2003 or Placebo Dose 1

EXPERIMENTAL

Daily for 28 days in patients with moderate hypertriglyceridemia

Drug: CAT-2003; Drug: Placebo

CAT-2003 or Placebo Dose 2

EXPERIMENTAL

Daily for 28 days in patients with moderate hypertriglyceridemia

Drug: CAT-2003; Drug: Placebo

CAT-2003 or Placebo Dose 3

EXPERIMENTAL

Daily for 28 days in patients with moderate hypertriglyceridemia

Drug: CAT-2003; Drug: Placebo

CAT-2003 or Placebo Dose 4

EXPERIMENTAL

Daily for 28 days in patients with hypercholesterolemia who are on a statin

Drug: CAT-2003; Drug: Placebo; Drug: Statin

Interventions

CAT-2003 DRUG

CAT-2003 or Placebo Dose 1; CAT-2003 or Placebo Dose 2; CAT-2003 or Placebo Dose 3; CAT-2003 or Placebo Dose 4

Placebo DRUG

CAT-2003 or Placebo Dose 1; CAT-2003 or Placebo Dose 2; CAT-2003 or Placebo Dose 3; CAT-2003 or Placebo Dose 4

Statin DRUG

All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.

CAT-2003 or Placebo Dose 4

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catabasis Pharmaceuticals: lead

Study Sites (14)

Unknown Facility

Muscle Shoals, Alabama, 35662, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Jacksonville, Florida, 32223, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

Winter Park, Florida, 32792, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

Louisville, Kentucky, 40213, United States

Location

Unknown Facility

Auburn, Maine, 04120, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Cincinnati, Ohio, 45219, United States

Location

Unknown Facility

Cincinnati, Ohio, 45227, United States

Location

Unknown Facility

Cincinnati, Ohio, 45246, United States

Location

Unknown Facility

Sainte-Foy, Quebec, G1V 4M6, Canada

Location

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia; Hypertriglyceridemia

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

CA (1); US (13)