Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Hypercholesterolemia Clinical Trial

— PATHWAYS I  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912560
• Other study ID #: CAT-2003-201
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2013
• Last updated: July 26, 2016
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2016
• Source: Catabasis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemias
• Hypertriglyceridemia

Intervention

Drug:
• CAT-2003

• Placebo

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catabasis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia		4 weeks	No
Primary	Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia		4 weeks	No
Secondary	Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol		4 weeks	No
Secondary	Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia		4 weeks	No
Secondary	Frequency of adverse events	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.	4 weeks	Yes