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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01912560
Other study ID # CAT-2003-201
Secondary ID
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


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
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