HyperlipidemiaPhase 2MBX-8025NCT00701883
Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
A Phase 2 study testing MBX-8025 and Atorvastatin in people with Hyperlipidemia, run by Gilead Sciences at 28 sites in United States.
Trial summary
A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvastatin Total… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- MBX-8025 and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 28 sitesUnited States
- Study dates
- Aug 2007to Aug 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years
- Female patients must not be pregnant or breast-feeding
- Patients must be moderately overweight
- All patients must have abnormal cholesterol levels or a history of abnormal cholesterol levels as defined by the protocol.
- Patients taking medication to lower their cholesterol must be willing, in some cases, to discontinue their medications during the study Stable weight (a history of increasing or decreasing no more than 6.6 lbs [3 kg]) for at least 2 months prior to the study;
Who cannot join
- Cancer or a history of a cancer within 5 years before screening, other than some skin cancers
- Patients planning elective surgery during the study
- Patients with a history of diabetes mellitus at study onset
- History of intolerance to, or adverse effect from atorvastatin
- History of weight loss due to stomach bypass or eating disorder
- All patients may not have had a stroke, TIA, an acute myocardial infarction, angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization) lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy) within 5 months of screening
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Rochester Clinical Research
Albuquerque, New Mexico, 87108
Maine Research Associates
Auburn, Maine, 46260
Health Trends Research LLC
Baltimore, Maryland, 21209
United Medical Associates P.C.
Binghamton, New York, 13901
Radiant Research
Birmingham, Alabama, 35209
Bridgewater Medical Group
Bridgewater, New Jersey, 08807
Tricities Medical Research
Bristol, Tennessee, 37620
Clifton-Wallington Medical Group
Clifton, New Jersey, 07013
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
PharmQuest
Greensboro, North Carolina, 27401
Radiant Research
Greer, South Carolina, 29651
Diabetes/Lipid Management and Research Center
Huntington Beach, California, 92648
Genesis Research International
Indianapolis, Indiana, 46260
Midwest Institute for Clinical Research Inc.
Indianapolis, Indiana, 46260
Holston Medical Group Clinical Research
Kingsport, Tennessee, 37660
L-Marc Research Center
Louisville, Kentucky, 40213
Clinical Research Consulting LLC
Milford, Connecticut, 06460
PHA-Adult Medicine
Philadelphia, Pennsylvania, 19146
Anasazi Internal Medicine Research
Phoenix, Arizona, 85032
Rochester Clinical Research
Rochester, New York, 14609
Crescent Medical Research
Salisbury, North Carolina, 28144
Diabetes and Glandular Disease Research
San Antonio, Texas, 78229
Radiant Research
Santa Rosa, California, 95405
Troy Internal Medicine Research
Troy, Michigan, 48098
Walla Walla Clinic
Walla Walla, Washington, 99362
Southgate Medical Group
West Seneca, New York, 14224
Great Lakes Medical Research
Westfield, New York, 14787
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: Multicenter Randomized Double-Blind Placebo and Active Comparator Controlled Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MBX-8025 in Moderately Obese Hyperlipidemic Patients With/Out Concomitant Atorvastatin"
A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvastatin
Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.
Read the detailed description
Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.
- Conditions
- Hyperlipidemia
- Being tested
- Placebo, MBX-8025, Atorvastatin
- Keywords
- Cholesterol, Hyperlipidemia, HDL, LDL, Triglycerides, Dyslipidemia
- Medical subject headings
- Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 capsules, once a day for 8 weeks
MBX-8025Drug
2 capsules, once daily for 8 weeks
MBX-8025Drug
2 capsule, once daily for 8 weeks
AtorvastatinDrug
2 capsules, once daily for 8 weeks
MBX-8025Drug
2 capsules, once daily for 8 weeks
MBX-8025Drug
2 capsules, once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MBX-8025 50 mg/Placebo | Experimental | Not described Receives: Drug: Placebo; Drug: MBX-8025 |
| MBX-8025 100 mg/Placebo | Experimental | Not described Receives: Drug: Placebo; Drug: MBX-8025 |
| Placebo/Atorvastatin 20 mg | Active comparator | Not described Receives: Drug: Placebo; Drug: Atorvastatin |
| MBX-8025 50 mg/Atorvastatin 20 mg | Experimental | Not described Receives: Drug: Atorvastatin; Drug: MBX-8025 |
| MBX-8025 100 mg/Atorvastatin 20 mg | Experimental | Not described Receives: Drug: Atorvastatin; Drug: MBX-8025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug
Measured: 8 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Roberts, M.D., Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701883
- Sponsor's protocol ID
- 70,961
- Other IDs
- M8025-20711
- Acronym
- MBX-8025
- Status last verified
- May 2015
- First submitted
- 17 Jun 2008
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi YJ, Roberts BK, Wang X, Geaney JC, Naim S, Wojnoonski K, Karpf DB, Krauss RM. Effects of the PPAR-delta agonist MBX-8025 on atherogenic dyslipidemia. Atherosclerosis. 2012 Feb;220(2):470-6. doi: 10.1016/j.atherosclerosis.2011.10.029. Epub 2011 Nov 16.
PubMed 22169113Bays HE, Schwartz S, Littlejohn T 3rd, Kerzner B, Krauss RM, Karpf DB, Choi YJ, Wang X, Naim S, Roberts BK. MBX-8025, a novel peroxisome proliferator receptor-delta agonist: lipid and other metabolic effects in dyslipidemic overweight patients treated with and without atorvastatin. J Clin Endocrinol Metab. 2011 Sep;96(9):2889-97. doi: 10.1210/jc.2011-1061. Epub 2011 Jul 13.
PubMed 21752880
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Double-Blind Placebo and Active Comparator Controlled Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MBX-8025 in Moderately Obese Hyperlipidemic Patients With/Out Concomitant Atorvastatin"
- ClinicalTrials.gov ID
- NCT00701883
- Acronym / sponsor ID
- MBX-8025 / 70,961
- Conditions
- Hyperlipidemia
- Keywords
- Cholesterol, Hyperlipidemia, HDL, LDL, Triglycerides, Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Jun 2008 (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 Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvastatin
Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.
Detailed description
Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo/Placebo | Placebo comparator | Drug: Placebo |
| MBX-8025 50 mg/Placebo | Experimental | Drug: Placebo, Drug: MBX-8025 |
| MBX-8025 100 mg/Placebo | Experimental | Drug: Placebo, Drug: MBX-8025 |
| Placebo/Atorvastatin 20 mg | Active comparator | Drug: Placebo, Drug: Atorvastatin |
| MBX-8025 50 mg/Atorvastatin 20 mg | Experimental | Drug: Atorvastatin, Drug: MBX-8025 |
| MBX-8025 100 mg/Atorvastatin 20 mg | Experimental | Drug: Atorvastatin, Drug: MBX-8025 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-75 years
- Female patients must not be pregnant or breast-feeding
- Patients must be moderately overweight
- All patients must have abnormal cholesterol levels or a history of abnormal cholesterol levels as defined by the protocol.
- Patients taking medication to lower their cholesterol must be willing, in some cases, to discontinue their medications during the study Stable weight (a history of increasing or decreasing no more than 6.6 lbs [3 kg]) for at least 2 months prior to the study;
Key exclusion criteria (6 listed)
- Cancer or a history of a cancer within 5 years before screening, other than some skin cancers
- Patients planning elective surgery during the study
- Patients with a history of diabetes mellitus at study onset
- History of intolerance to, or adverse effect from atorvastatin
- History of weight loss due to stomach bypass or eating disorder
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 |
|---|---|---|
| Placebo2 capsules, once a day for 8 weeks | Drug | MBX-8025 100 mg/Placebo, MBX-8025 50 mg/Placebo, Placebo/Atorvastatin 20 mg, Placebo/Placebo |
| MBX-80252 capsules, once daily for 8 weeks | Drug | MBX-8025 50 mg/Placebo |
| MBX-80252 capsule, once daily for 8 weeks | Drug | MBX-8025 100 mg/Placebo |
| Atorvastatin2 capsules, once daily for 8 weeks | Drug | MBX-8025 100 mg/Atorvastatin 20 mg, MBX-8025 50 mg/Atorvastatin 20 mg, Placebo/Atorvastatin 20 mg |
| MBX-80252 capsules, once daily for 8 weeks | Drug | MBX-8025 50 mg/Atorvastatin 20 mg |
| MBX-80252 capsules, once daily for 8 weeks | Drug | MBX-8025 100 mg/Atorvastatin 20 mg |
Primary outcome
Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug
Time frame: 8 week treatment period
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 12 Jun 2015.
- Derived from this study: PubMed 22169113Choi YJ, Roberts BK, Wang X, Geaney JC, Naim S, Wojnoonski K, Karpf DB, Krauss RM. Effects of the PPAR-delta agonist MBX-8025 on atherogenic dyslipidemia. Atherosclerosis. 2012 Feb;220(2):470-6. doi: 10.1016/j.atherosclerosis.2011.10.029. Epub 2011 Nov 16.
- Derived from this study: PubMed 21752880Bays HE, Schwartz S, Littlejohn T 3rd, Kerzner B, Krauss RM, Karpf DB, Choi YJ, Wang X, Naim S, Roberts BK. MBX-8025, a novel peroxisome proliferator receptor-delta agonist: lipid and other metabolic effects in dyslipidemic overweight patients treated with and without atorvastatin. J Clin Endocrinol Metab. 2011 Sep;96(9):2889-97. doi: 10.1210/jc.2011-1061. Epub 2011 Jul 13.
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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.
Brian Roberts, M.D. study director
Gilead Sciences
28 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 MBX-8025 and Atorvastatin in people with Hyperlipidemia, run by Gilead Sciences at 28 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 5 inclusion and 6 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 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 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?
Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug (time frame: 8 week treatment period). 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 NCT00701883, which also lists 2 linked publications.
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 Jun 2015.