HyperlipidemiasPhase 2NCT01968720
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
A Phase 2 study testing CAT-2003 in people with Hyperlipidemias and Hypertriglyceridemia, run by Catabasis Pharmaceuticals at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias
- What is being tested?
- CAT-2003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of any major cardiovascular event within 6 months of Screening
- Type I diabetes mellitus or use of insulin
- History of pancreatitis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Auburn, Maine, 04210
Study site
Cincinnati, Ohio, 45227
Study site
Indianapolis, Indiana, 46260
Study site
Miami, Florida, 33143
About this study
Official title: A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia
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.
- Conditions
- Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
- Being tested
- CAT-2003, Placebo
- Medical subject headings
- Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT-2003Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CAT-2003 or Placebo | Experimental | All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period. Receives: Drug: CAT-2003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
Measured: 4 weeks
Secondary outcomes (2)
Frequency of adverse events
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.
Measured: 4 weeks
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catabasis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968720
- Sponsor's protocol ID
- CAT-2003-202
- Status last verified
- Jul 2015
- First submitted
- 21 Oct 2013
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01968720
- Acronym / sponsor ID
- CAT-2003-202
- Conditions
- Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAT-2003 or Placebo | Experimental | Drug: CAT-2003, Drug: PlaceboAll patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- History of any major cardiovascular event within 6 months of Screening
- Type I diabetes mellitus or use of insulin
- History of pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAT-2003 | Drug | CAT-2003 or Placebo |
| Placebo | Drug | CAT-2003 or Placebo |
Primary outcome
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
Time frame: 4 weeks
2 secondary outcomes
Frequency of adverse events
Time frame: 4 weeks
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAT-2003 in people with Hyperlipidemias and Hypertriglyceridemia, run by Catabasis Pharmaceuticals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.