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CompletedNCT02098278Updated Jul 21, 2016

Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia

A Phase 2 interventional study of CAT-2003 and Placebo in Lipoprotein Lipase Deficiency, Familial, Hyperlipoproteinemia Type I and Chylomicronemia, Familial, sponsored by Catabasis Pharmaceuticals. Completed at 2 sites in Canada. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-07-21.

Sponsored by Catabasis Pharmaceuticals (part of BioCryst Pharmaceuticals) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lipoprotein Lipase Deficiency, Familial
  • Hyperlipoproteinemia Type I
  • Chylomicronemia, Familial
  • Hypertriglyceridemia
03

In context

Hyperlipoproteinemia Type I

25 studies on the registry are indexed under Hyperlipoproteinemia Type I; 3 are open to participants now.

This study's enrollment of 13 is below the median of 16 across 13 interventional studies indexed under Hyperlipoproteinemia Type I.

Browse Hyperlipoproteinemia Type I studies →

Lead sponsor

Catabasis Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.

First submitted before Catabasis Pharmaceuticals became part of BioCryst Pharmaceuticals.

Browse Catabasis Pharmaceuticals studies →All BioCryst Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    CAT-2003 or Placebo

    All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.

    Drug: CAT-2003 · Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Percent change from baseline in fasting triglycerides in patients with chylomicronemia

    Time frame: 12 Weeks

Secondary outcomes

  1. Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels

    Time frame: 12 Weeks

  2. Absolute and percent change from baseline on chylomicron triglyceride clearance

    Time frame: 12 Weeks

  3. Absolute and percent change from baseline in plasma non-HDL-C

    Time frame: 12 Weeks

  4. Frequency of adverse events

    Time frame: 13 weeks

07

Study locations

2 sites
  • Chicoutimi, Quebec G7H 7K9, Canada
  • Québec, Quebec G1V 4M6, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2014
First posted
Mar 28, 2014
Start
Mar 2014
Primary completionActual
Apr 2015
CompletionActual
Apr 2015
Results delay requested
Jul 19, 2016
Last update
Jul 21, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02098278
Lead sponsor
Catabasis Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 28, 2014
Start date
Mar 2014
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Jul 21, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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