CompletedPhase 2

Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia

Canada13 participantsStarted 2014-03

Plain-language summary

The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride clearance. This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.

Who can participate

Age range18 Years – 74 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Familial Chylomicronemia (Fasting triglycerides ≥ 880 mg/dL at Screening and documented history of plasma post-heparin LDL activity \< 20% of normal or genetic confirmation of homozygosity or compound heterozygosity for loss-of-function mutations in familial chylomicronemia-causing genes) OR * Non-familial Chylomicronemia (Fasting triglycerides ≥ 440 mg/dL at Screening and documented history of fasting triglycerides ≥ 880 mg/dL) Key Exclusion Criteria: * History of any major cardiovascular event within 6 months of Screening * Type I diabetes mellitus or use of insulin * History of pancreatitis within 3 month of Screening

What they're measuring

Percent change from baseline in fasting triglycerides in patients with chylomicronemia

Timeframe: 12 Weeks

Trial details

NCT IDNCT02098278

SponsorCatabasis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04

View on ClinicalTrials.gov More Lipoprotein Lipase Deficiency, Familial trials