ObesityPhase 3NCT00483171
A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients
A Phase 3 study testing CP-945,598, Non-pharmacological weight loss program (NPP) and Low Calorie Diet in people with Obesity, run by Pfizer at 26 sites in 5 countries.
Trial summary
The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- CP-945,598, Non-pharmacological weight loss program (NPP) and Low Calorie Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 699 participants
- Where
- 26 sitesin 5 countries
- Study dates
- Jan 2008to Jan 2009
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be overweight (BMI) >/=30 kg/m2, for subjects without co morbidities; >/=27 kg/m2 for subjects with co morbidities
- Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Who cannot join
- Participation in a formal weight loss program or significant weight loss (fluctuation >5% of total body weight) in the past 3 months.
- Subjects with serious medical or psychiatric conditions
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
United States9 sites
Pfizer Investigational Site
Baton Rouge, Louisiana, 70808
Pfizer Investigational Site
Boston, Massachusetts, 02118
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
New York, New York, 10021-7903
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Seattle, Washington, 98108
Pfizer Investigational Site
St Louis, Missouri, 63110
Australia5 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Bedford Park, South Australia, 5042
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Heidelberg, Victoria, 3081
Pfizer Investigational Site
Kippa-Ring, Queensland, 4021
Denmark4 sites
Pfizer Investigational Site
Aarhus, 8000
Pfizer Investigational Site
Frederiksberg C, 1958
Pfizer Investigational Site
Gentofte Municipality, 2820
Pfizer Investigational Site
Roskilde, 4000
Netherlands4 sites
Pfizer Investigational Site
Almere Stad, 1311 RL
Pfizer Investigational Site
Amsterdam, 1081 HV
Pfizer Investigational Site
Amsterdam, 1105 AZ
Pfizer Investigational Site
Hilversum, 1213 RH
South Africa4 sites
Pfizer Investigational Site
Cape Town, Gauteng, 7708
Pfizer Investigational Site
Johannesburg, Gauteng, 7500
Pfizer Investigational Site
Pretoria, Gauteng, 0157
Pfizer Investigational Site
Pretoria
About this study
Official title: A 14-Month, Randomized, Double-Blind,Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety of CP-945,598 In Prevention Of Weight Regain In Obese Subjects
The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.
Read the detailed description
The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.
- Conditions
- Obesity
- Being tested
- CP-945,598, Non-pharmacological weight loss program (NPP), Low Calorie Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-945,598Drug
CP-945,598
Non-pharmacological weight loss program (NPP)Behavioural
Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
Low Calorie DietBehavioural
Low calorie diet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: CP-945,598 |
| Non-pharmacological weight loss program (NPP) | Other | Not described Receives: Behavioral: Non-pharmacological weight loss program (NPP) |
| Low Calorie Diet | Other | Not described Receives: Behavioral: Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
Measured: 14 months
Secondary outcomes (5)
To explore the effect of CP 954, 598 on: Waist circumference
Measured: 14 months
To evaluate the safety and tolerability of CP 945,598 urine and blood tests
Measured: 14 months
To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin
Measured: 14 months
To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale
Measured: 14 months
To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: See termination reason in detailed description.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 699 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
- NCT00483171
- Sponsor's protocol ID
- A5351028
- Status last verified
- Nov 2012
- First submitted
- 4 Jun 2007
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14-Month, Randomized, Double-Blind,Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety of CP-945,598 In Prevention Of Weight Regain In Obese Subjects
- ClinicalTrials.gov ID
- NCT00483171
- Acronym / sponsor ID
- A5351028
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 699 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Jun 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 if CP-945,598 is effective in the prevention of weight regain in obese subjects.
Detailed description
The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: CP-945,598 |
| Non-pharmacological weight loss program (NPP) | Other | Behavioral: Non-pharmacological weight loss program (NPP) |
| Low Calorie Diet | Other | Behavioral: Low Calorie Diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must be overweight (BMI) >/=30 kg/m2, for subjects without co morbidities; >/=27 kg/m2 for subjects with co morbidities
- Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Key exclusion criteria (2 listed)
- Participation in a formal weight loss program or significant weight loss (fluctuation >5% of total body weight) in the past 3 months.
- Subjects with serious medical or psychiatric conditions
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-945,598CP-945,598 | Drug | Placebo |
| Non-pharmacological weight loss program (NPP)Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP. | Behavioural | Non-pharmacological weight loss program (NPP) |
| Low Calorie DietLow calorie diet | Behavioural | Low Calorie Diet |
Primary outcome
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
Time frame: 14 months
5 secondary outcomes
To explore the effect of CP 954, 598 on: Waist circumference
Time frame: 14 months
To evaluate the safety and tolerability of CP 945,598 urine and blood tests
Time frame: 14 months
To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin
Time frame: 14 months
To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale
Time frame: 14 months
To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview
Time frame: 14 months
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CP-945,598, Non-pharmacological weight loss program (NPP) and Low Calorie Diet in people with Obesity, run by Pfizer at 26 sites in 5 countries.
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: stopped early, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, Denmark, Netherlands, South Africa. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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?
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks). (time frame: 14 months). 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 7 Nov 2012.