HypercholesterolemiaPhase 1NCT02374047

A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects

A Phase 1 study testing CAT-2054, CAT-2054-C and Atorvastatin in people with Hypercholesterolemia, run by Catabasis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia
What is being tested?: CAT-2054, CAT-2054-C and Atorvastatin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 118 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Jul 2015
Phase: Phase 1
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of written informed consent before any study-specific procedure
Good health as determined by medical history, physical examination, vital sign measurements, ECG, and clinical laboratory measurements
Satisfies one of the following:
Females not of childbearing potential: non-pregnant and non-lactating surgically sterile or postmenopausal 2 years or less with a follicle-stimulating hormone assessment greater than or equal to 40 IU/L
Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose
For Part B only, measured at Screening: Fasting LDL-C ≥100 mg/dL; or (Cohort B6 only) fasting LDL-C ≥130 mg/dL
Body mass index (BMI) between 18 and 30 kg/m², inclusive, for Part A and between 18 and 40 kg/m², inclusive, for Part B, and body weight >50 kg at Screening

Who cannot join

Use of prescription drugs or non-prescription drugs including herbals, and dietary supplements (including multivitamins and any product containing niacin or omega-3 fatty acids above the Recommended Daily Allowance) within 2 weeks before dosing. Additionally for Part B only, use of any lipid-regulating prescription drug, non-prescription drug, herbal, or dietary supplement within 6 weeks before dosing
Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF >450
Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Clinical Research
West Bend, Wisconsin, 53095

Other trials in United States

About this study

This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054) or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess safety in anticipation of future clinical trials.

Conditions: Hypercholesterolemia
Being tested: CAT-2054, Placebo, CAT-2054-C, 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
CAT-2054-CDrug
AtorvastatinDrug

Study groups in NCT02374047
Study group	Role	What they receive
Cohort A1, Dose Level 1: CAT-2054 or placebo fasting	Experimental	Single dose Receives: Drug: CAT-2054; Drug: Placebo
Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed	Experimental	Single dose Receives: Drug: CAT-2054; Drug: Placebo
Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed	Experimental	Single dose Receives: Drug: CAT-2054; Drug: Placebo
Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed	Experimental	Single dose Receives: Drug: CAT-2054; Drug: Placebo
Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed	Experimental	Single dose Receives: Drug: Placebo; Drug: CAT-2054-C
Cohort B1, Dose Level 1: CAT-2054 or placebo	Experimental	Multiple dose for 14 days Receives: Drug: CAT-2054; Drug: Placebo
Cohort B2, Dose Level 2: CAT-2054 or placebo	Experimental	Multiple dose for 14 days Receives: Drug: CAT-2054; Drug: Placebo
Cohort B3, Dose Level 3: CAT-2054 or placebo	Experimental	Multiple dose for 14 days Receives: Drug: CAT-2054; Drug: Placebo
Cohort B4, Dose Level 4: CAT-2054 or placebo	Experimental	Multiple dose for 14 days Receives: Drug: CAT-2054; Drug: Placebo
Cohort B5, Dose Level 5: CAT-2054 or placebo	Experimental	Multiple dose for 14 days Receives: Drug: CAT-2054; Drug: Placebo
Cohort B6, Dose Level 6: CAT-2054 with atorvastatin	Experimental	Multiple dose for 14 days Receives: Drug: CAT-2054; Drug: Atorvastatin
Cohort B7, Dose Level 7: CAT-2054 or placebo	Experimental	Multiple dose for 14 days Receives: Drug: CAT-2054; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency and severity of adverse events
Measured: up to 3 weeks

Secondary outcomes (5)

AUCinf of CAT-2054
Measured: Days 1 through 4
Cmax of CAT-2054
Measured: up to 3 weeks
Changes from baseline for hematology, chemistry, coagulation and urinalysis
Measured: up to 3 weeks
Assess the pharmacodynamic effects of multiple doses of CAT-2054 on serum lipids LDL-C, non-HDL-C, total cholesterol, triglycerides, HDL-C, apoB, and PCSK9.
Measured: up to 3 weeks
AUC48 of Atorvastatin
Measured: up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jul 2015

First posted27 Feb 2015 (estimated)
Study startJan 2015
Primary completionJul 2015
Study completionJul 2015

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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02374047
Sponsor's protocol ID: CAT-2054-101
Status last verified: Jan 2021
First submitted: 2 Feb 2015
Last updated: 28 Jan 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects
ClinicalTrials.gov ID: NCT02374047
Acronym / sponsor ID: CAT-2054-101
Conditions: Hypercholesterolemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 27 Feb 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
Cohort A1, Dose Level 1: CAT-2054 or placebo fasting	Experimental	Drug: CAT-2054, Drug: PlaceboSingle dose
Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed	Experimental	Drug: CAT-2054, Drug: PlaceboSingle dose
Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed	Experimental	Drug: CAT-2054, Drug: PlaceboSingle dose
Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed	Experimental	Drug: CAT-2054, Drug: PlaceboSingle dose
Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed	Experimental	Drug: Placebo, Drug: CAT-2054-CSingle dose
Cohort B1, Dose Level 1: CAT-2054 or placebo	Experimental	Drug: CAT-2054, Drug: PlaceboMultiple dose for 14 days
Cohort B2, Dose Level 2: CAT-2054 or placebo	Experimental	Drug: CAT-2054, Drug: PlaceboMultiple dose for 14 days
Cohort B3, Dose Level 3: CAT-2054 or placebo	Experimental	Drug: CAT-2054, Drug: PlaceboMultiple dose for 14 days
Cohort B4, Dose Level 4: CAT-2054 or placebo	Experimental	Drug: CAT-2054, Drug: PlaceboMultiple dose for 14 days
Cohort B5, Dose Level 5: CAT-2054 or placebo	Experimental	Drug: CAT-2054, Drug: PlaceboMultiple dose for 14 days
Cohort B6, Dose Level 6: CAT-2054 with atorvastatin	Experimental	Drug: CAT-2054, Drug: AtorvastatinMultiple dose for 14 days
Cohort B7, Dose Level 7: CAT-2054 or placebo	Experimental	Drug: CAT-2054, Drug: PlaceboMultiple dose for 14 days

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Provision of written informed consent before any study-specific procedure
Good health as determined by medical history, physical examination, vital sign measurements, ECG, and clinical laboratory measurements
Satisfies one of the following:
For Part B only, measured at Screening: Fasting LDL-C ≥100 mg/dL; or (Cohort B6 only) fasting LDL-C ≥130 mg/dL
Body mass index (BMI) between 18 and 30 kg/m², inclusive, for Part A and between 18 and 40 kg/m², inclusive, for Part B, and body weight >50 kg at Screening

Key exclusion criteria (4 listed)

Use of prescription drugs or non-prescription drugs including herbals, and dietary supplements (including multivitamins and any product containing niacin or omega-3 fatty acids above the Recommended Daily Allowance) within 2 weeks before dosing. Additionally for Part B only, use of any lipid-regulating prescription drug, non-prescription drug, herbal, or dietary supplement within 6 weeks before dosing
Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF >450
Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer

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	Cohort A1, Dose Level 1: CAT-2054 or placebo fasting, Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed, Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed, Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed, Cohort B1, Dose Level 1: CAT-2054 or placebo, Cohort B2, Dose Level 2: CAT-2054 or placebo, Cohort B3, Dose Level 3: CAT-2054 or placebo, Cohort B4, Dose Level 4: CAT-2054 or placebo, Cohort B5, Dose Level 5: CAT-2054 or placebo, Cohort B6, Dose Level 6: CAT-2054 with atorvastatin, Cohort B7, Dose Level 7: CAT-2054 or placebo
Placebo	Drug	Cohort A1, Dose Level 1: CAT-2054 or placebo fasting, Cohort A2, Dose Level 2: CAT-2054 or placebo fasting and fed, Cohort A3, Dose Level 3: CAT-2054 or placebo fasting and fed, Cohort A4, Dose Level 4: CAT-2054 or placebo fasting and fed, Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed, Cohort B1, Dose Level 1: CAT-2054 or placebo, Cohort B2, Dose Level 2: CAT-2054 or placebo, Cohort B3, Dose Level 3: CAT-2054 or placebo, Cohort B4, Dose Level 4: CAT-2054 or placebo, Cohort B5, Dose Level 5: CAT-2054 or placebo, Cohort B7, Dose Level 7: CAT-2054 or placebo
CAT-2054-C	Drug	Cohort A5, Dose Level 5: CAT-2054-C or placebo fasting and fed
Atorvastatin	Drug	Cohort B6, Dose Level 6: CAT-2054 with atorvastatin

Primary outcome

Frequency and severity of adverse events
Time frame: up to 3 weeks

5 secondary outcomes

AUCinf of CAT-2054
Time frame: Days 1 through 4
Cmax of CAT-2054
Time frame: up to 3 weeks
Changes from baseline for hematology, chemistry, coagulation and urinalysis
Time frame: up to 3 weeks
Assess the pharmacodynamic effects of multiple doses of CAT-2054 on serum lipids LDL-C, non-HDL-C, total cholesterol, triglycerides, HDL-C, apoB, and PCSK9.
Time frame: up to 3 weeks
AUC48 of Atorvastatin
Time frame: up to 3 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 Jan 2021.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAT-2054, CAT-2054-C and Atorvastatin in people with Hypercholesterolemia, run by Catabasis Pharmaceuticals at 1 site 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 7 inclusion and 4 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Frequency and severity of adverse events (time frame: up to 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02374047.

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 Jan 2021.