HyperlipidemiaPhase 2NCT00559962
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
A Phase 2 study testing AEGR-733, AEGR-733 and atorvastatin and AEGR-733 and fenofibrate in people with Hyperlipidemia, run by Aegerion Pharmaceuticals, Inc. at 15 sites in United States.
Trial summary
To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- AEGR-733, AEGR-733 and atorvastatin and AEGR-733 and fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LDL-C between 100 and 190 mg/dL
- Hepatic fat under 6.2% per MRS
Who cannot join
- Pregnant or lactating females
- Uncontrolled hypertension >180/95 mmHg
- Chronic renal insufficiency - serum creatinine >2.5 mg/dL at screen
- Liver disease; i.e., hepatitis, cirrhosis
- Major surgery within 3 months of screen
- Cardiac insufficiency
Show all 23Show fewer
- Hx of malignancy other than basal or squamous cell within past 5 yrs
- Participation in any investigational drug study within 6 wks of screen
- Prior exposure to AEGR-733 in past 12 months
- Serious or unstable medical or psychological conditions
- More than one alcoholic drink per day
- Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4
- Currently taking corticosteroids
- Other lipid-lowering meds (washout permitted)
- Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted)
- Acute CVD or event within previous 6 months
- Diabetes Mellitus
- Hepatitis B or C
- Medicated COPD
- Idiopathic pulmonary fibrosis
- G.I. disorders that cause chronic diarrhea
- Fasting triglycerides =/> 400 mg/dL
- Body Mass Index > 35kg/m2
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Maine Research Associates
Auburn, Maine, 04210
Health Trends Research
Baltimore, Maryland, 21209
Johns Hopkins
Baltimore, Maryland, 21287
Radiant Research
Chicago, Illinois, 60610
Sterling Research Group
Cincinnati, Ohio, 45219
Baylor College of Medicine
Houston, Texas, 77030
Clinical Trial Network
Houston, Texas, 77074
University of Iowa
Iowa City, Iowa, 52242
LMARC
Louisville, Kentucky, 40213
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
dgd Research
San Antonio, Texas, 78229
Scripps Clinic
San Diego, California, 92128
Radiant Research
Santa Rosa, California, 95405
Washington Univ. School of Medicine
St Louis, Missouri, 63110
MedStar Research Institute
Washington D.C., District of Columbia, 20003
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Low Doses of the MTP-Inhibitor AEGR-733 on Hepatic Fat Accumulation as Measured by Magnetic Resonance Spectroscopy
To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy
Read the detailed description
The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of MTP-I on hepatic fat accumulation.
- Conditions
- Hyperlipidemia
- Being tested
- AEGR-733, placebo, AEGR-733 and atorvastatin, AEGR-733 and fenofibrate, AEGR-733 and ezetimibe
- Keywords
- LDL, hepatic fat
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEGR-733Drug
3 capsules each evening for each 4-week period
placeboDrug
3 capsules each evening for each 4-week period
AEGR-733Drug
3 capsules each evening for each 4-week period
AEGR-733Drug
3 capsules each evening for each 4-week period
AEGR-733Drug
3 capsules each evening for each 4-week period
AEGR-733 and atorvastatinDrug
3 capsules each evening for each 4-week period
AEGR-733 and fenofibrateDrug
3 capsules each evening for each 4-week period
AEGR-733 and ezetimibeDrug
3 capsules each evening for each 4-week period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: placebo |
| 2 | Active comparator | 2.5 mg AEGR-733 Receives: Drug: AEGR-733 |
| 3 | Active comparator | 5 mg AEGR-733 Receives: Drug: AEGR-733 |
| 4 | Active comparator | 7.5 mg AEGR-733 Receives: Drug: AEGR-733 |
| 5 | Active comparator | 10 mg AEGR-733 Receives: Drug: AEGR-733 |
| 6 | Active comparator | 5 mg AEGR-733 + 20 mg atorvastatin Receives: Drug: AEGR-733 and atorvastatin |
| 7 | Active comparator | 5 mg AEGR-733 + 145 mg fenofibrate Receives: Drug: AEGR-733 and fenofibrate |
| 8 | Active comparator | 5 mg AEGR-733 + 10 mg ezetimibe Receives: Drug: AEGR-733 and ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Measured: Baseline and 12 weeks on study drug
Secondary outcomes (1)
Absolute Change From Baseline in Percent Hepatic Fat
Absolute change from Baseline in percent hepatic fat
Measured: Baseline and 12 weeks on study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperlipidemiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Sasiela, PhD, Study director, Aegerion Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559962
- Sponsor's protocol ID
- AEGR-733-004
- Status last verified
- Feb 2018
- First submitted
- 15 Nov 2007
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Low Doses of the MTP-Inhibitor AEGR-733 on Hepatic Fat Accumulation as Measured by Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT00559962
- Acronym / sponsor ID
- AEGR-733-004
- Conditions
- Hyperlipidemia
- Keywords
- LDL, hepatic fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Posted 22 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy
Detailed description
The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of MTP-I on hepatic fat accumulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboPlacebo |
| 2 | Active comparator | Drug: AEGR-7332.5 mg AEGR-733 |
| 3 | Active comparator | Drug: AEGR-7335 mg AEGR-733 |
| 4 | Active comparator | Drug: AEGR-7337.5 mg AEGR-733 |
| 5 | Active comparator | Drug: AEGR-73310 mg AEGR-733 |
| 6 | Active comparator | Drug: AEGR-733 and atorvastatin5 mg AEGR-733 + 20 mg atorvastatin |
| 7 | Active comparator | Drug: AEGR-733 and fenofibrate5 mg AEGR-733 + 145 mg fenofibrate |
| 8 | Active comparator | Drug: AEGR-733 and ezetimibe5 mg AEGR-733 + 10 mg ezetimibe |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LDL-C between 100 and 190 mg/dL
- Hepatic fat under 6.2% per MRS
Key exclusion criteria (23 listed)
- Pregnant or lactating females
- Uncontrolled hypertension >180/95 mmHg
- Chronic renal insufficiency - serum creatinine >2.5 mg/dL at screen
- Liver disease; i.e., hepatitis, cirrhosis
- Major surgery within 3 months of screen
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 |
|---|---|---|
| AEGR-7333 capsules each evening for each 4-week period | Drug | 2 |
| placebo3 capsules each evening for each 4-week period | Drug | 1 |
| AEGR-7333 capsules each evening for each 4-week period | Drug | 3 |
| AEGR-7333 capsules each evening for each 4-week period | Drug | 4 |
| AEGR-7333 capsules each evening for each 4-week period | Drug | 5 |
| AEGR-733 and atorvastatin3 capsules each evening for each 4-week period | Drug | 6 |
| AEGR-733 and fenofibrate3 capsules each evening for each 4-week period | Drug | 7 |
| AEGR-733 and ezetimibe3 capsules each evening for each 4-week period | Drug | 8 |
Primary outcome
Absolute Change From Baseline in Percent Hepatic Fat
Time frame: Baseline and 12 weeks on study drug
Absolute change from Baseline in percent hepatic fat
1 secondary outcome
Absolute Change From Baseline in Percent Hepatic Fat
Time frame: Baseline and 12 weeks on study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William Sasiela, PhD study director
Aegerion Pharmaceuticals, Inc.
15 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 AEGR-733, AEGR-733 and atorvastatin and AEGR-733 and fenofibrate in people with Hyperlipidemia, run by Aegerion Pharmaceuticals, Inc. at 15 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 2 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: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Yes. Results are posted in the registry (first posted 22 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change From Baseline in Percent Hepatic Fat (time frame: Baseline and 12 weeks on study drug). 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 23 Feb 2018.