HypercholesterolemiaPhase 2NCT02608697
A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
A Phase 2 study testing CAT-2054 and Atorvastatin in people with Hypercholesterolemia, run by Catabasis Pharmaceuticals at 34 sites in United States.
Trial summary
The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- CAT-2054 and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 34 sitesUnited States
- Study dates
- Oct 2015to Jun 2016
- 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
- Hypercholesterolemia (LDL-C ≥ 70 mg/dL and < 190 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening
- Satisfies one of the following:
- Female patients of childbearing potential must have used appropriate and highly effective contraception (a regimen which results in a failure rate of <1% per year) with their partners for 4 weeks prior to Screening, and remain compliant during the treatment phase and until 4 weeks after the last dose of investigational product
- Male patients must use an acceptable and highly effective contraceptive method during the treatment phase and until 4 weeks after the last dose of investigational product
- Body mass index (BMI) ≤45 kg/m2
Who cannot join
- History of any major cardiovascular event (stroke, TIA, MI, PTCI, CABG, hospitalization due to heart failure) within 6 months of Screening
- Type I diabetes mellitus or use of insulin
- Active peptic ulcer disease or a history of muscle disease or myopathy
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study site
Auburn, Maine, 04210
Study site
Brooksville, Florida, 34601
Study site
Chicago, Illinois, 60607
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45227
Study site
Cincinnati, Ohio, 45246
Study site
Columbus, Ohio, 43213
Study site
Evanston, Illinois, 60201
Study site
Franklin, Ohio, 45005
Study site
Hialeah, Florida, 33012
Study site
Houston, Texas, 77036
Study site
Houston, Texas, 77074
Study site
Huntington Park, California, 90255
Study site
Indianapolis, Indiana, 46260
Study site
Jupiter, Florida, 33458
Study site
Kansas City, Kansas, 66160
Study site
Las Vegas, Nevada, 89123
Study site
Lomita, California, 90717
Study site
Los Angeles, California, 90057
Study site
Louisville, Kentucky, 40213
Study site
Lyndhurst, Ohio, 44124
Study site
Marion, Ohio, 43302
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Muscle Shoals, Alabama, 35662
Study site
New York, New York, 10029
Study site
Olympia, Washington, 98502
Study site
Orem, Utah, 84058
Study site
Pembroke Pines, Florida, 33026
Study site
Richmond, Virginia, 23294
Study site
Rochester, New York, 14609
Study site
Summerville, South Carolina, 29485
Study site
Troy, Michigan, 48098
Study site
Willoughby Hills, Ohio, 44094
Study site
Winter Park, Florida, 32792
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- CAT-2054, Placebo, Atorvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT-2054Drug
PlaceboDrug
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1: CAT-2054 or Placebo Dose 1 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily. Receives: Drug: CAT-2054; Drug: Placebo; Drug: Atorvastatin |
| Group 2: CAT-2054 or Placebo Dose 2 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily. Receives: Drug: CAT-2054; Drug: Placebo; Drug: Atorvastatin |
| Group 3: CAT-2054 or Placebo Dose 3 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily. Receives: Drug: CAT-2054; Drug: Placebo; Drug: Atorvastatin |
| Group 4: CAT-2054 or Placebo Dose 4 | Experimental | A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily. Receives: Drug: CAT-2054; Drug: Placebo; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C from baseline in patients with hypercholesterolemia.
Measured: 4 weeks
Secondary outcomes (2)
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: 8 weeks
Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
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 posted20 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- 153 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
- NCT02608697
- Sponsor's protocol ID
- CAT-2054-201
- Status last verified
- Jun 2017
- First submitted
- 11 Nov 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT02608697
- Acronym / sponsor ID
- CAT-2054-201
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Nov 2015 (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 placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks.
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 |
|---|---|---|
| Group 1: CAT-2054 or Placebo Dose 1 | Experimental | Drug: CAT-2054, Drug: Placebo, Drug: AtorvastatinA run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily. |
| Group 2: CAT-2054 or Placebo Dose 2 | Experimental | Drug: CAT-2054, Drug: Placebo, Drug: AtorvastatinA run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily. |
| Group 3: CAT-2054 or Placebo Dose 3 | Experimental | Drug: CAT-2054, Drug: Placebo, Drug: AtorvastatinA run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily. |
| Group 4: CAT-2054 or Placebo Dose 4 | Experimental | Drug: CAT-2054, Drug: Placebo, Drug: AtorvastatinA run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18 and 74 years at Screening
- Hypercholesterolemia (LDL-C ≥ 70 mg/dL and < 190 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening
- Satisfies one of the following:
- Body mass index (BMI) ≤45 kg/m2
Key exclusion criteria (3 listed)
- History of any major cardiovascular event (stroke, TIA, MI, PTCI, CABG, hospitalization due to heart failure) within 6 months of Screening
- Type I diabetes mellitus or use of insulin
- Active peptic ulcer disease or a history of muscle disease or myopathy
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-2054 | Drug | Group 1: CAT-2054 or Placebo Dose 1, Group 2: CAT-2054 or Placebo Dose 2, Group 3: CAT-2054 or Placebo Dose 3, Group 4: CAT-2054 or Placebo Dose 4 |
| Placebo | Drug | Group 1: CAT-2054 or Placebo Dose 1, Group 2: CAT-2054 or Placebo Dose 2, Group 3: CAT-2054 or Placebo Dose 3, Group 4: CAT-2054 or Placebo Dose 4 |
| Atorvastatin | Drug | Group 1: CAT-2054 or Placebo Dose 1, Group 2: CAT-2054 or Placebo Dose 2, Group 3: CAT-2054 or Placebo Dose 3, Group 4: CAT-2054 or Placebo Dose 4 |
Primary outcome
Percent change in LDL-C from baseline in patients with hypercholesterolemia.
Time frame: 4 weeks
2 secondary outcomes
Frequency of adverse events
Time frame: 8 weeks
Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
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 20 Jun 2017.
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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.
34 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-2054 and Atorvastatin in people with Hypercholesterolemia, run by Catabasis Pharmaceuticals at 34 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 6 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 in LDL-C from baseline in patients with hypercholesterolemia. (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 20 Jun 2017.