ObesityPhase 3NCT00391196
A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients
A Phase 3 study testing CP-945,598 and CP-945,598 Treatment B in people with Obesity, run by Pfizer at 91 sites in 11 countries.
Trial summary
The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients. 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 and CP-945,598 Treatment B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 975 participants
- Where
- 91 sitesin 11 countries
- Study dates
- Nov 2006to 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
- Subjects must be overweight (BMI 27- 50 kg/m2)
- Subjects must have type 2 diabetes mellitus
Who cannot join
- Pregnancy
- Serious or unstable current or past medical conditions
Trial locations and contacts
91 sites in 11 countries.
91 sites in 11 countries
United States43 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87108
Pfizer Investigational Site
Auburn, Maine, 04210
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Baton Rouge, Louisiana, 70808
Pfizer Investigational Site
Bay City, Michigan, 48706
Pfizer Investigational Site
Beaver, Pennsylvania, 15009
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Buffalo, New York, 14209
Pfizer Investigational Site
Chandler, Arizona, 85224
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Greenville, North Carolina, 27834
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Mesa, Arizona, 85213
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Morgantown, West Virginia, 26506-9136
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Britain, Connecticut, 06050
Pfizer Investigational Site
New York, New York, 10025
Pfizer Investigational Site
Orlando, Florida, 32809
Pfizer Investigational Site
Palm Springs, California, 92262
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860
Pfizer Investigational Site
Phoenix, Arizona, 85014
Pfizer Investigational Site
Renton, Washington, 98057
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78237
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Washington D.C., District of Columbia, 20003-4393
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Canada7 sites
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1E 1J7
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, G2E 2X1
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
Pfizer Investigational Site
Thornhill, Ontario, L4J 8L7
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
Brazil6 sites
Pfizer Investigational Site
Curitiba, Paraná, 80030-110
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170
Pfizer Investigational Site
São Paulo, São Paulo, 01221-020
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030
Pfizer Investigational Site
São Paulo, São Paulo, 04025-011
Pfizer Investigational Site
São Paulo, São Paulo, 05403-000
Germany6 sites
Pfizer Investigational Site
Berlin, 13125
Pfizer Investigational Site
Dresden, 01219
Pfizer Investigational Site
Düsseldorf, 40225
Pfizer Investigational Site
Hamburg, 20253
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Mittweida, 09648
United Kingdom6 sites
Pfizer Investigational Site
Bath, Somerset, BA1 3NG
Pfizer Investigational Site
Coventry, CV2 2DX
Pfizer Investigational Site
Dumfries, DG1 4AP
Pfizer Investigational Site
Dundee, DD1 9SY
Pfizer Investigational Site
Edinburgh, Lothian, EH4 2XU
Pfizer Investigational Site
Luton, LU4 0DZ
Australia5 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Box Hill, Victoria, 3128
Pfizer Investigational Site
Garran, Australian Capital Territory, 2605
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Pfizer Investigational Site
Wollongong, New South Wales, 2500
Czechia5 sites
Pfizer Investigational Site
Břeclav, 690 02
Pfizer Investigational Site
České Budějovice, 370 87
Pfizer Investigational Site
Olomouc, 772 00
Pfizer Investigational Site
Prague, 128 08
Pfizer Investigational Site
Praha 4 - Krc, 140 21
Mexico4 sites
Pfizer Investigational Site
Guadalajara, Jalisco, 44340
Pfizer Investigational Site
Mexico City, Mexico City, 11850
Pfizer Investigational Site
Monterrey, Nuevo León, 64460
Pfizer Investigational Site
Tampico, Cd. Madero, 89109
Slovakia4 sites
Pfizer Investigational Site
Banská Bystrica, 975 17
Pfizer Investigational Site
Bratislava, Slovakia, 813 69
Pfizer Investigational Site
Ľubochňa, Slovakia, 034 91
Pfizer Investigational Site
Nitra, Slovakia, 950 01
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, C1034ACO
Pfizer Investigational Site
Buenos Aires, C1405CWB
Pfizer Investigational Site
Buenos Aires, C1426ABP
Sweden2 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Huddinge, 141 86
About this study
Official title: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.
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
- Placebo, CP-945,598, CP-945,598 Treatment B
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subjects receive placebo plus non-pharmacological weight loss program.
CP-945,598Drug
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
CP-945,598 Treatment BDrug
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CP-945,598 | Experimental | Not described Receives: Drug: CP-945,598 |
| CP-945,598 Treatment B | Experimental | Subjects receive CP-945,598 plus non-pharmacological weight loss program. Receives: Drug: CP-945,598 Treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline.
Measured: 1 year
Secondary outcomes (24)
Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
Measured: 1 year
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
Measured: 1 year
Change from baseline in waist circumference at 1 year;
Measured: 1 year
Change from baseline fasting triglyceride and HDL concentrations at 1 year;
Measured: 1 year
Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;
Measured: 1 year
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
Measured: 1 year
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
Measured: 1 year
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
Measured: 1 year
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
Measured: 1 year
Change from baseline fasting plasma glucose concentration at 1 year;
Measured: 1 year
Change from baseline in Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7 scores at months 1, 2, 3, 5, 6, 9, and 1 year;
Measured: 1 year
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
Measured: 1 year
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
Measured: 1 year
Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;
Measured: 1 year
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
Measured: 1 year
Waist circumference at months 3, 6, and 9;
Measured: 1 year
Fasting triglyceride and HDL concentrations at month 6 and patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at months 3 and 6;
Measured: 1 year
Change from baseline in laboratory tests and ECGs at 1 year; vitals signs at (at Week 2, Months 1 - 6, 9, 11 and 1 year) and adverse events;
Measured: 1 year
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
Measured: 1 year
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
Measured: 1 year
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
Measured: 1 year
Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;
Measured: 1 year
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
Measured: 1 year
Change from baseline HbA1c to 1 year;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- 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
- 975 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
- NCT00391196
- Sponsor's protocol ID
- A5351022
- Status last verified
- Nov 2012
- First submitted
- 19 Oct 2006
- 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 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00391196
- Acronym / sponsor ID
- A5351022
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 975 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Oct 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 if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.
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: Placebo |
| CP-945,598 | Experimental | Drug: CP-945,598 |
| CP-945,598 Treatment B | Experimental | Drug: CP-945,598 Treatment BSubjects receive CP-945,598 plus non-pharmacological weight loss program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must be overweight (BMI 27- 50 kg/m2)
- Subjects must have type 2 diabetes mellitus
Key exclusion criteria (2 listed)
- Pregnancy
- Serious or unstable current or past medical 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 |
|---|---|---|
| PlaceboSubjects receive placebo plus non-pharmacological weight loss program. | Drug | Placebo |
| CP-945,598Subjects receive CP-945,598 plus non-pharmacological weight loss program. | Drug | CP-945,598 |
| CP-945,598 Treatment BSubjects receive CP-945,598 plus non-pharmacological weight loss program. | Drug | CP-945,598 Treatment B |
Primary outcome
Percent change in body weight from baseline.
Time frame: 1 year
24 secondary outcomes
Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
Time frame: 1 year
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
Time frame: 1 year
Change from baseline in waist circumference at 1 year;
Time frame: 1 year
Change from baseline fasting triglyceride and HDL concentrations at 1 year;
Time frame: 1 year
Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;
Time frame: 1 year
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
Time frame: 1 year
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
Time frame: 1 year
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
Time frame: 1 year
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
Time frame: 1 year
Change from baseline fasting plasma glucose concentration at 1 year;
Time frame: 1 year
Change from baseline in Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7 scores at months 1, 2, 3, 5, 6, 9, and 1 year;
Time frame: 1 year
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
Time frame: 1 year
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
Time frame: 1 year
Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;
Time frame: 1 year
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
Time frame: 1 year
Waist circumference at months 3, 6, and 9;
Time frame: 1 year
Fasting triglyceride and HDL concentrations at month 6 and patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at months 3 and 6;
Time frame: 1 year
Change from baseline in laboratory tests and ECGs at 1 year; vitals signs at (at Week 2, Months 1 - 6, 9, 11 and 1 year) and adverse events;
Time frame: 1 year
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
Time frame: 1 year
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
Time frame: 1 year
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
Time frame: 1 year
Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;
Time frame: 1 year
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
Time frame: 1 year
Change from baseline HbA1c to 1 year;
Time frame: 1 year
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.
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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
91 sites in 11 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 and CP-945,598 Treatment B in people with Obesity, run by Pfizer at 91 sites in 11 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 91 sites in United States, Canada, Brazil, Germany, United Kingdom and 6 more countries. 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 change in body weight from baseline. (time frame: 1 year). 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.