HypercholesterolemiaPhase 2NCT00879112
Study of MB07811 in Subjects With Hypercholesterolemia
A Phase 2 study testing MB07811 in people with Hypercholesterolemia, run by Ligand Pharmaceuticals at 11 sites in United States.
Trial summary
A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- MB07811
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2009to Dec 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) 18.50 - 40 kg/m2 inclusive at screening;
- Fasting serum LDL-C ≥145 mg/dL at both Q2 and Q3 visits;
- Fasting mean serum LDL-C <220 mg/dL from Q2 and Q3;
Who cannot join
- History of clinically significant cardiovascular disease
- Uncontrolled hypertension
- Significant sinus bradycardia defined as <40 beats per minute (bpm);
- Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome;
- Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency > 1 per minute, any alert criteria or any other condition that requires further evaluation;
- History of clinical significant arrhythmia;
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- Resting 12-lead ECG showing QTc >450 msec or <360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality;
- Any other cardiovascular event requiring hospitalization;
- History or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; Exceptions: polycystic ovarian syndrome (PCOS) and impaired glucose tolerance (IGT) are allowed.
- Liver disease, gallbladder disease, Gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (NASH), positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies; Exceptions: gallbladder disease treated with cholecystectomy
- History of human immunodeficiency virus (HIV);
- Subjects with a prior history of malignancy in past 5 years;Exceptions: Subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated;
- History of myopathy, including any history of statin-induced myopathy;
- History of intolerance to statins (e.g., myalgias, elevated liver tests);
- History of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis;
- Renal dysfunction;
- Alcohol and/or drug abuse within 12 months prior to screening;
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Radiant Research
Chicago, Illinois, 60654
Research Across America
Dallas, Texas, 75234
Coastal Carolina Research Center, Inc.
Goose Creek, South Carolina, 29445
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Commonwealth Biomedical Research
Madisonville, Kentucky, 42431
National Clinical Research - Norfolk
Norfolk, Virginia, 23502
University Clinical Research
Pembroke Pines, Florida, 33024
National Clinical Research
Richmond, Virginia, 23294
Scripps Clinic, Clinical Research
San Diego, California, 92128
Troy Internal Medicine
Troy, Michigan, 48098
About this study
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of MB07811 for 12 Weeks Followed by a 6-Week Off Drug Phase in Subjects With Primary Hypercholesterolemia
A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.
Read the detailed description
This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. There will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. Eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of MB07811 for 12 weeks. After the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. Assessments include: laboratory tests, adverse events (AEs), electrocardiograms (ECGs), vitals, and PK samples.
- Conditions
- Hypercholesterolemia
- Being tested
- MB07811, Placebo
- Keywords
- Hyperlipidemia
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB07811Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MB07811 Cohort 1 Receives: Drug: MB07811 |
| 2 | Experimental | MB07811 Cohort 2 Receives: Drug: MB07811 |
| 3 | Experimental | MB07811 Cohort 3 Receives: Drug: MB07811 |
| 4 | Placebo comparator | Cohort 4 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effects of MB07811 compared to placebo on LDL-C
Measured: 12-weeks of treatment
Secondary outcomes (2)
Evaluate the effects of MB07811 on other lipid markers compared to placebo
Measured: 12 weeks
Assess the safety and tolerability of MB07811
Measured: after 12 weeks of treatment and during off-drug phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Study terminated prior to initiation
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Trish Novak, Ph.D., Study director, Metabasis Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879112
- Sponsor's protocol ID
- MB07811-201
- Status last verified
- Aug 2011
- First submitted
- 8 Apr 2009
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of MB07811 for 12 Weeks Followed by a 6-Week Off Drug Phase in Subjects With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00879112
- Acronym / sponsor ID
- MB07811-201
- Conditions
- Hypercholesterolemia
- Keywords
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated prior to initiation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 9 Apr 2009 (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.
A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.
Detailed description
This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. There will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. Eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of MB07811 for 12 weeks. After the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. Assessments include: laboratory tests, adverse events (AEs), electrocardiograms (ECGs), vitals, and PK samples.
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 |
|---|---|---|
| 1 | Experimental | Drug: MB07811MB07811 Cohort 1 |
| 2 | Experimental | Drug: MB07811MB07811 Cohort 2 |
| 3 | Experimental | Drug: MB07811MB07811 Cohort 3 |
| 4 | Placebo comparator | Drug: PlaceboCohort 4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) 18.50 - 40 kg/m2 inclusive at screening;
- Fasting serum LDL-C ≥145 mg/dL at both Q2 and Q3 visits;
- Fasting mean serum LDL-C <220 mg/dL from Q2 and Q3;
Key exclusion criteria (17 listed)
- History of clinically significant cardiovascular disease
- Uncontrolled hypertension
- Significant sinus bradycardia defined as <40 beats per minute (bpm);
- Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome;
- Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency > 1 per minute, any alert criteria or any other condition that requires further evaluation;
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 |
|---|---|---|
| MB07811Oral | Drug | 1, 2, 3 |
| PlaceboOral | Drug | 4 |
Primary outcome
Evaluate the effects of MB07811 compared to placebo on LDL-C
Time frame: 12-weeks of treatment
2 secondary outcomes
Evaluate the effects of MB07811 on other lipid markers compared to placebo
Time frame: 12 weeks
Assess the safety and tolerability of MB07811
Time frame: after 12 weeks of treatment and during off-drug phase
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
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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.
Trish Novak, Ph.D. study director
Metabasis Therapeutics, Inc.
11 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 MB07811 in people with Hypercholesterolemia, run by Ligand Pharmaceuticals at 11 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 3 inclusion and 17 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: withdrawn, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the effects of MB07811 compared to placebo on LDL-C (time frame: 12-weeks of treatment). 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 12 Aug 2011.