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

This study has been completed.
Information provided by (Responsible Party):
Catabasis Pharmaceuticals Identifier:
First received: October 21, 2013
Last updated: July 27, 2015
Last verified: July 2015

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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01968720

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 Identifier: NCT01968720     History of Changes
Other Study ID Numbers: CAT-2003-202
Study First Received: October 21, 2013
Last Updated: July 27, 2015

Additional relevant MeSH terms:
Metabolic Diseases
Lipid Metabolism Disorders processed this record on September 21, 2017