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Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968720
First Posted: October 24, 2013
Last Update Posted: August 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Catabasis Pharmaceuticals
  Purpose

The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia.

This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.


Condition Intervention Phase
Hyperlipidemias Hypertriglyceridemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Drug: CAT-2003 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia

Resource links provided by NLM:


Further study details as provided by Catabasis Pharmaceuticals:

Primary Outcome Measures:
  • Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Frequency of adverse events [ Time Frame: 4 weeks ]

    Safety 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.


  • Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels [ Time Frame: 4 weeks ]

Enrollment: 16
Study Start Date: October 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAT-2003 or Placebo
All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
Drug: CAT-2003 Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18 and 74 years at Screening
  • Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose 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 or use of insulin
  • History of pancreatitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968720


Locations
United States, Florida
Miami, Florida, United States, 33143
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Maine
Auburn, Maine, United States, 04210
United States, Ohio
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Catabasis Pharmaceuticals
  More Information

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01968720     History of Changes
Other Study ID Numbers: CAT-2003-202
First Submitted: October 21, 2013
First Posted: October 24, 2013
Last Update Posted: August 14, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Metabolic Diseases
Hypertriglyceridemia
Lipid Metabolism Disorders