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HyperlipidemiaPhase 2REASCENDNCT02532218

Evaluation of ARI-3037MO, to Suppress LDL Cholesterol in Patients With Dyslipidemia

A Phase 2 study testing ARI-3037MO in people with Hyperlipidemia, run by Arisaph Pharmaceuticals Inc at 19 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with dyslipidemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperlipidemia
What is being tested?
ARI-3037MO
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
19 sitesUnited States
Study dates
Aug 2015to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at screening.
  • Women of childbearing potential, must agree to use 2 medically accepted, effective methods of birth control. Females who are postmenopausal must have been postmenopausal for > 1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle-stimulating hormone level must be elevated and consistent with postmenopausal levels (i.e., > 40 IU/L); otherwise these subjects must agree to use contraceptives listed above.
  • Male subjects with sexual partners of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening through 12 weeks after last dose of study drug to prevent pregnancy in a partner.
  • Female subjects of childbearing potential (including females with questionable postmenopausal status) must have a negative pregnancy test prior to dosing.
  • LDL-C level: ≥ 100 mg/dL.
  • Triglycerides (TG) ≤ 300 mg/dL.
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  • High-density lipoprotein cholesterol (HDL-C) level < 45 mg/dL in men and < 50 mg/dL in women.
  • Subject understands the trial requirements and the treatment procedures, is willing to comply with all protocol-required follow-up evaluation and provides written informed consent
  • Subjects will be managed according to current standard of care. Subjects taking statin therapy will remain on their statin background therapy and must be on a stable dose, defined as no changes in the dose of statin in the 3 months prior to screening, and must be willing and able to remain on that dose for the duration of the study.

Who cannot join

  • Subjects treated with any statin at its maximally approved dose will be excluded from the study.
  • Body mass index (BMI) > 45 kg/m2.
  • Weight change ≥ 3 kg during the lead-in period.
  • Uncontrolled diabetes, defined as glycosylated hemoglobin (HbA1C) > 9.5%.
  • Contraindication to niacin treatment (prior flushing is not regarded as a contraindication to niacin treatment).
  • History of stroke, myocardial infarction, life-threatening arrhythmia, or having had coronary vascularization within 6 months before screening.
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  • Thyroid-stimulating hormone ≥ 1.5 times the upper limit of normal (ULN).
  • Clinical evidence of hypothyroidism or thyroid hormonal therapy that has not been stable for ≥ 6 weeks before screening.
  • Creatine kinase concentration ≥ 3 times the ULN.
  • Known, active liver disease, including but not limited to
  • Confirmed alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase ≥ 2 times the ULN, or bilirubin ≥ 1.5 times the ULN.
  • Hepatitis C (anti-hepatitis C virus immunoglobulin G +).
  • Hepatitis B (hepatitis B surface antigen +, anti-hepatitis B core antigen immunoglobulin M +).
  • Blood donation of ≥ 1 pint (0.5 L) within 30 days before screening or plasma donation within 7 days before screening.
  • Known nephrotic syndrome or ≥ 3 g/day proteinuria.
  • Past organ transplant or on a waiting list for an organ transplant.
  • Subject is currently receiving chemotherapy; or has received chemotherapy within the 30 days prior to screening; or is scheduled to receive chemotherapy during the course of the study.
  • Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months.
  • Problems with substance abuse, which, in the opinion of the Investigator, might affect study compliance.
  • Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
  • Participation in another investigational drug trial in the past 30 days or current participation in a device trial that has not reached its primary endpoint.
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study or within 12 weeks after last dose of study drug.
  • Estimated glomerular filtration rate < 60 mL/min/1.73 m2. -

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Catalina Reserch Institute, LLC

    Chino, California, 91710

  • Sterling Research Group Ltd

    Cincinnati, Ohio, 45219

  • The Carl and Edyth Lindner Center for Reserch and education at the Christ Hospital

    Cincinnati, Ohio, 45219

  • Metabolic and atherosclerosis Research center

    Cincinnati, Ohio, 45227

  • IVA reserch

    Cincinnati, Ohio, 45245

  • Sterling Research group, Ltd

    Cincinnati, Ohio, 45246

  • Willamette Valley Clinical studies

    Eugene, Oregon, 97404

  • S&W Clinical Reserch

    Fort Lauderdale, Florida, 33306

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Jacksonville Center for Clinical Research

    Jacksonvile, Florida, 32216

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisville, Kentucky, 40213

  • Ohio Clinical Research-Lyndhurst

    Lyndhurst, Ohio, 44124

  • Sestron Clinical Research 833 Campbell Hill Street Suite 230

    Marietta, Georgia, 30060

  • Health Research of Hampton Roads - Norfolk

    Norfolk, Virginia, 23502

  • COR Clinical Research

    Oklahoma City, Oklahoma, 73103

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Raninier Clinical Reserach

    Renton, Washington, 98057

  • National Clinical Research inc

    Richmond, Virginia, 23294

  • Rochester clinical Research,Inc

    Rochester, New York, 14069

Other trials in United States

About this study

Official title: Randomized Evaluation of ARI-3037MO, to Suppress LDL Cholesterol in Patients With Dyslipidemia

The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with dyslipidemia.

Read the detailed description

This study is a prospective, multi-center, randomized, double-blinded, controlled clinical trial. The study will compare two arms: ARI-3037MO 3 g BID vs. placebo.

Subjects who sign informed consent will be enrolled and will undergo all Visit 1 assessments. Following evaluation of Visit 1 laboratory assays, eligible subjects will receive a phone call (Visit 2) during which they will be instructed to begin the lifestyle modification and enter a 4- to 6-week lead-in period (6-week wash-out period for subjects to wash out of non-statin lipid-lowering therapy [subjects may remain on statins during this period], 4 weeks for subjects receiving statins only or not receiving any lipid-lowering therapy), followed by a qualifying fasting LDL-C measurement at Visit 3. After the lead-in period, if the LDL-C level at Visit 3 is not ≥ 100 mg/dL, an additional week will be allowed for another qualifying measurement at a subsequent visit (Visit 3.1). If performed, the LDL-C level at Visit 3.1 must be ≥ 100 mg/dL in order for the subject to continue participation in the study. Qualifying subjects will be randomized in a 1:1 manner at Visit 4 to one of two arms of the double-blind, 24-week efficacy and safety assessment phase. Randomization will be stratified by background statin therapy status at Visit 1 (yes/no). Baseline lipid levels will be defined as lipid levels at Visit 4. End-of-study lipid levels will be defined as the lipid levels at Visit 7 (Week 24).

A final closeout and safety assessment visit will be held at 26 weeks post randomization (Visit 8).

Conditions
Hyperlipidemia
Being tested
ARI-3037MO
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARI-3037MODrug

    Lipid lowering treatment Statins

Study groups in NCT02532218
Study groupRoleWhat they receive
ActiveActive comparatorARI-3037MO (niacin analog) 3g bid for 24 wks
Receives: Drug: ARI-3037MO
PlaceboPlacebo comparatorMatching Placebo 3g bid for 24 wks
Receives: Drug: ARI-3037MO

What is being measured

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

  1. LDL-c

    change in LDL cholesterol level

    Measured: 24 wks

Secondary outcomes (3)

  1. HDL-c

    Change in HDL cholesterol

    Measured: 24 wks

  2. TG

    Change in triglyceride levels

    Measured: 24 wks

  3. HbA1C

    Change in hemoglobin A1C

    Measured: 24 wks

Timeline

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

  1. First posted25 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionSep 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

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
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02532218
Sponsor's protocol ID
ARI-3037MO-005
Acronym
REASCEND
Status last verified
Sep 2015
First submitted
21 Aug 2015
Last updated
8 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARI-3037MO in people with Hyperlipidemia, run by Arisaph Pharmaceuticals Inc at 19 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 9 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

LDL-c (time frame: 24 wks). 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 NCT02532218.

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 8 Aug 2016.

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