DyslipidemiaPhase 2PATHWAYS INCT01912560
Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia
A Phase 2 study testing CAT-2003 and Statin in people with Dyslipidemia and Hypercholesterolemia, run by Catabasis Pharmaceuticals at 14 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
- What is being tested?
- CAT-2003 and Statin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jul 2013to Dec 2013
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 69 years at Screening
- Hypertriglyceridemia (TG ≥ 200 mg/dL and < 500 mg/dL and non-HDL-C ≥ 100 mg/dL and < 220 mg/dL) OR
- Hypercholesterolemia (LDL-C ≥ 100 mg/dL and < 190 mg/dL and TG value < 200 mg/dL) plus a stable dose of statin 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
- Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
- Any statin at the highest approved dose
- Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
- Active peptic ulcer disease or a history of muscle disease or myopathy
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Study site
Auburn, Maine, 04120
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45227
Study site
Cincinnati, Ohio, 45246
Study site
Jacksonville, Florida, 32223
Study site
Kansas City, Kansas, 66160
Study site
Los Angeles, California, 90057
Study site
Louisville, Kentucky, 40213
Study site
Miami, Florida, 33143
Study site
Muscle Shoals, Alabama, 35662
Study site
Raleigh, North Carolina, 27609
Study site
Raleigh, North Carolina, 27612
Study site
Winter Park, Florida, 32792
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)
The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.
- Conditions
- Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
- Being tested
- CAT-2003, Placebo, Statin
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT-2003Drug
PlaceboDrug
StatinDrug
All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.
| Study group | Role | What they receive |
|---|---|---|
| CAT-2003 or Placebo Dose 1 | Experimental | Daily for 28 days in patients with moderate hypertriglyceridemia Receives: Drug: CAT-2003; Drug: Placebo |
| CAT-2003 or Placebo Dose 2 | Experimental | Daily for 28 days in patients with moderate hypertriglyceridemia Receives: Drug: CAT-2003; Drug: Placebo |
| CAT-2003 or Placebo Dose 3 | Experimental | Daily for 28 days in patients with moderate hypertriglyceridemia Receives: Drug: CAT-2003; Drug: Placebo |
| CAT-2003 or Placebo Dose 4 | Experimental | Daily for 28 days in patients with hypercholesterolemia who are on a statin Receives: Drug: CAT-2003; Drug: Placebo; Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia
Measured: 4 weeks
Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia
Measured: 4 weeks
Secondary outcomes (3)
Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol
Measured: 4 weeks
Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia
Measured: 4 weeks
Frequency of adverse events
Safety and tolerability 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 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
- NCT01912560
- Sponsor's protocol ID
- CAT-2003-201
- Acronym
- PATHWAYS I
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2013
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)
- ClinicalTrials.gov ID
- NCT01912560
- Acronym / sponsor ID
- PATHWAYS I / CAT-2003-201
- Conditions
- Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jul 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 different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CAT-2003 or Placebo Dose 1 | Experimental | Drug: CAT-2003, Drug: PlaceboDaily for 28 days in patients with moderate hypertriglyceridemia |
| CAT-2003 or Placebo Dose 2 | Experimental | Drug: CAT-2003, Drug: PlaceboDaily for 28 days in patients with moderate hypertriglyceridemia |
| CAT-2003 or Placebo Dose 3 | Experimental | Drug: CAT-2003, Drug: PlaceboDaily for 28 days in patients with moderate hypertriglyceridemia |
| CAT-2003 or Placebo Dose 4 | Experimental | Drug: CAT-2003, Drug: Placebo, Drug: StatinDaily for 28 days in patients with hypercholesterolemia who are on a statin |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 69 years at Screening
- Hypertriglyceridemia (TG ≥ 200 mg/dL and < 500 mg/dL and non-HDL-C ≥ 100 mg/dL and < 220 mg/dL) OR
- Hypercholesterolemia (LDL-C ≥ 100 mg/dL and < 190 mg/dL and TG value < 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.
- Body mass index (BMI) ≤ 45 kg/m2
Key exclusion criteria (6 listed)
- History of any major cardiovascular event within 6 months of Screening
- Type I diabetes mellitus
- Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
- Any statin at the highest approved dose
- Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
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 Dose 1, CAT-2003 or Placebo Dose 2, CAT-2003 or Placebo Dose 3, CAT-2003 or Placebo Dose 4 |
| Placebo | Drug | CAT-2003 or Placebo Dose 1, CAT-2003 or Placebo Dose 2, CAT-2003 or Placebo Dose 3, CAT-2003 or Placebo Dose 4 |
| StatinAll patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen. | Drug | CAT-2003 or Placebo Dose 4 |
Primary outcome
Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia
Time frame: 4 weeks
Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia
Time frame: 4 weeks
3 secondary outcomes
Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol
Time frame: 4 weeks
Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia
Time frame: 4 weeks
Frequency of adverse events
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 28 Jul 2016.
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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.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAT-2003 and Statin in people with Dyslipidemia and Hypercholesterolemia, run by Catabasis Pharmaceuticals at 14 sites in 2 countries.
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 4 inclusion and 6 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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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?
Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 28 Jul 2016.