ObesityPhase 2NCT00479492
Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
A Phase 2 study testing CP-866,087 in people with Obesity, run by Pfizer at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- CP-866,087
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2007to Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of >110 lbs.
- Otherwise healthy
Who cannot join
- Women must be of non-childbearing potential.
- Significant current or history of medical illness.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
Pfizer Investigational Site
Orlando, Florida, 32809
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A 12-Week, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-866,087 On Weight Loss In Obese, Otherwise Healthy Adult Subjects
The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.
- Conditions
- Obesity
- Being tested
- CP-866,087, placebo
- Keywords
- Obesity, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-866,087Drug
1 mg of CP-866,087, administered QD for 84 days
CP-866,087Drug
5 mg of CP-866,087, administered QD for 84 days
CP-866,087Drug
10 mg of CP-866,087, administered QD for 84 days
placeboDrug
placebo administered QD for 84 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CP-866,087 |
| 2 | Experimental | Not described Receives: Drug: CP-866,087 |
| 3 | Experimental | Not described Receives: Drug: CP-866,087 |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94.
Measured: 94 days
Secondary outcomes (6)
To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. Measured at Day 1 and Day 29
Measured: 29 days
Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.
Measured: 84 days
Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.
Measured: 94 days
To explore changes in pharmacodynamics (PD) markers of efficacy resulting from multiple PO doses of CP-866,087, including waist circumference, and serum lipids and exploratory biomarkers.
Measured: 94 days
Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.
Measured: 94 days
To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. Measured at Day 1, 28, 84 and 94.
Measured: 94 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionJan 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479492
- Sponsor's protocol ID
- A5051019
- Status last verified
- Oct 2008
- First submitted
- 24 May 2007
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-866,087 On Weight Loss In Obese, Otherwise Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00479492
- Acronym / sponsor ID
- A5051019
- Conditions
- Obesity
- Keywords
- Obesity, weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 28 May 2007 (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 CP-866,087 is effective in the weight loss of overweight patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CP-866,087 |
| 2 | Experimental | Drug: CP-866,087 |
| 3 | Experimental | Drug: CP-866,087 |
| 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of >110 lbs.
- Otherwise healthy
Key exclusion criteria (2 listed)
- Women must be of non-childbearing potential.
- Significant current or history of medical illness.
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-866,0871 mg of CP-866,087, administered QD for 84 days | Drug | 1 |
| CP-866,0875 mg of CP-866,087, administered QD for 84 days | Drug | 2 |
| CP-866,08710 mg of CP-866,087, administered QD for 84 days | Drug | 3 |
| placeboplacebo administered QD for 84 days | Drug | 4 |
Primary outcome
Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94.
Time frame: 94 days
6 secondary outcomes
To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. Measured at Day 1 and Day 29
Time frame: 29 days
Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.
Time frame: 84 days
Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.
Time frame: 94 days
To explore changes in pharmacodynamics (PD) markers of efficacy resulting from multiple PO doses of CP-866,087, including waist circumference, and serum lipids and exploratory biomarkers.
Time frame: 94 days
Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.
Time frame: 94 days
To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. Measured at Day 1, 28, 84 and 94.
Time frame: 94 days
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 1 Oct 2009.
- 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
4 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 CP-866,087 in people with Obesity, run by Pfizer at 4 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 2 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 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94. (time frame: 94 days). 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 1 Oct 2009.