ObesityPhase 1NCT00376285
Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033
A Phase 1 study testing CP-742,033 and Fenofibrate in people with Obesity, run by Pfizer.
Trial summary
The purpose of this study is to determine whether fenofibrate effects the toleration, safety, or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- CP-742,033 and Fenofibrate
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to not given
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 30-40 kg/m2
Who cannot join
- Women of childbearing potential
About this study
Official title: A Phase 1, Randomized, Investigator and Subject Blind, Sponsor Open Study to Determine the Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033 When Co-Administered in Otherwise Healthy Obese Adult Subjects
The purpose of this study is to determine whether fenofibrate effects the toleration, safety, or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity.
- Conditions
- Obesity
- Being tested
- CP-742,033, Fenofibrate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-742,033Drug
FenofibrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Toleration and safety
Secondary outcomes (1)
Efficacy biomarkers, serum lipids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376285
- Sponsor's protocol ID
- A5431015
- Status last verified
- Apr 2015
- First submitted
- 13 Sep 2006
- Last updated
- 22 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Investigator and Subject Blind, Sponsor Open Study to Determine the Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033 When Co-Administered in Otherwise Healthy Obese Adult Subjects
- ClinicalTrials.gov ID
- NCT00376285
- Acronym / sponsor ID
- A5431015
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- First posted
- 14 Sep 2006 (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.
The purpose of this study is to determine whether fenofibrate effects the toleration, safety, or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI of 30-40 kg/m2
Key exclusion criteria (1 listed)
- Women of childbearing potential
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 |
|---|---|---|
| CP-742,033 | Drug | – |
| Fenofibrate | Drug | – |
Primary outcome
Toleration and safety
1 secondary outcome
Efficacy biomarkers, serum lipids
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 22 Apr 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-742,033 and Fenofibrate in people with Obesity, run by Pfizer.
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 1 inclusion and 1 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Toleration and safety. 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 22 Apr 2015.