Clinical trial NCT01912560: Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Hypercholesterolemia
Hypertriglyceridemia
Lead sponsor: Catabasis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-07-31
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia
timeFrame: 4 weeks
measure: Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia
timeFrame: 4 weeks
Secondary outcomes:
measure: Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol
timeFrame: 4 weeks
measure: Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia
timeFrame: 4 weeks
measure: Frequency of adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Auburn
country: United States
state: Maine
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Sainte-Foy
country: Canada
state: Quebec
Study officials:
References: