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 - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000703-15-NL
• Date of registration: 17/10/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, United States
• Public 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 - N/A
• Scientific 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 - N/A
• Date of first enrolment: 17/12/2007
• Target sample size: 850
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000703-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Male and/or female subjects between 18 and 70 years of age inclusive,
2. For women of childbearing potential, a negative serum pregnancy test will be required prior to study inclusion. Female subjects must be surgically sterile or postmenopausal or must agree to use effective contraception during the study.
Note: Oral contraceptive use is permitted if used for at least 3 months before starting study medication.
Note: The definition of effective contraception will be based on the judgment of the Investigator or a designated associate.
3. Body Mass Index (BMI) =30 kg/m2, for subjects without co morbidities; =27 kg/m2 for subjects with co morbidities [treated or untreated hypertension and/or treated or untreated dyslipidemia]:
• Acceptable hypertension is defined as:
a. Blood pressure =140/90 mmHg and/or,
b. On anti hypertensive medication,
• Acceptable dyslipidemia is defined as:
a. LDL C not at goal according to local guidelines, and/or,
b. HDL C <40 mg/dL, and/or
c. Triglycerides =150, and/or,
d. On any anti dyslipidemic medication.
Note: Treated subjects for hypertension and/or dyslipidemia should have been on stable therapy for at least 2 months prior to screening.
4. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial;
5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Women who are pregnant or lactating, or who are planning to become pregnant;
2.Subjects with clinically significant abnormalities identified during the screening process. Specific exclusions include but are not limited to the following:
a.Subjects with systolic BP = 160 and/or diastolic BP = 100 mmHg or requiring new pharmacologic treatment or change in current treatment according to local guidelines;
b.Subjects with clinically significant cardiovascular disease, defines as unstable coronary heart disease (CHD), cerebrovascular disease (CVD) or peripheral vascular disease (PVD) and/or an event/intervention during the past 6 months
Note: Clinically stable subjects with a history of CHD, CVD or PVD, provided that the level of exercise proposed in the trial is deemed safe and appropriate for the subject may be included.
c.Subjects with dyslipidemia requiring new pharmacological treatment or a change in current treatment according to local guidelines;
d.Subjects with diabetes or fasting blood glucose concentration of =126mg/dl.
e.Subjects with renal disease including:
•Any history of nephrotic syndrome
•Chronic renal failure and/or serum creatinine >1.5 times the upper limit of normal (ULN).
f.Subjects with abnormal screening TSH values;
g.Subjects with significant hepatobiliary disease including:
•History of hepatitis B or C infection and/or,
•Aspartate aminotransferase or alanine aminotransferase =2 times the ULN.
h.History of HIV infection or use of antiretroviral agents;
i.Subjects with any prior history of malignancy except for:
1.Basal cell carcinoma of the skin curatively treated,
2.Other malignancies (regardless of site) that have been cancer-free for greater than 5 years prior to screening.
j.Subjects with gastrointestinal disease, surgery limiting drug absorption or previous history of surgical procedure for weight loss;
k.Clinical laboratory tests outside the pre-specified exclusionary limits;
l.Subjects with a history of CNS disorder including:
•A mood disturbance that meets the criteria for a Major Depressive Disorder within the last 10 years.
1. Requiring hospitalization or,
2. Two or more episodes of a major depressive disorder or,
3. Any previous suicide attempt
•Use of antidepressants that are known to increase weight;
Note: Subjects on a maintenance dose of a permitted antidepressant for a major depressive disorder, stable and in remission for at least 3 months prior to screening, and who plan to continue this treatment during the entire trial may be included.
•PHQ-9 (administered on the first day of the LCD (pre-randomization) and Day 1 (Randomization);
•PHQ score of =10 and a positive score to item 9 addressing suicidal ideas
•PHQ score >14 regardless of a positive or negative score to item 9 addressing suicidal ideas
Note: It may be possible to include some subjects with a score between 10-14, but who do not score positively on item 9 addressing suicidal ideas. However, these subjects will require further assessment to rule out a Major Depressive Disorder and other risk factors outlined in exclusion criterion L above prior to inclusion.
•Subjects with psychotic conditions or on antipsychotic pharmacotherapy;
•Subjects with seizure disorders who:
1.Are not controlled by current antiepileptic treatment, and/or
2.Are taking antiepileptic drugs (AEDs)
That are known to affect weight positively or negatively unless these medications have been taken at a stable dose for at least 6 months and the subject’s weight has been

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Obesity
MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity

Intervention(s)

Product Code: CP-945,598
Pharmaceutical Form: Film-coated tablet
CAS Number: 686347-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Code: CP-945,598
Pharmaceutical Form: Film-coated tablet
CAS Number: 686347-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To determine the effect of CP-945,598
•The proportion of subjects maintaining at least 25%, 50%, 75% or 100% of their initial weight loss
•Waist circumference
•Triglycerides
•HDL
•Changes in Patient Reported Outcome Scales: Uncontrolled Eating (from the Three Factor Eating Questionnaire R 21) and Power of Food (from the Power of Food Scale, USA or AMOTPIOTFE, ex USA)

To determine tolerability and safety aspects of CP-945,598:
•Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, total cholesterol, LDL C, adiponectin;
•CNS Self-Report Questionnaires: Generalized Anxiety Disorder-7 items (GAD-7); Patient Health Questionnaire-9 items (PHQ-9);
•Columbia Suicide-Severity Rating Scale (C-SSRS);
•Sun-Related Adverse Events;
•Patient reported outcomes scales from the Three Factor Eating Questionnaire R 21, Power of Food Scale, EQ-5D, and the Impact of Weight on Quality of Life Lite not identified as secondary endpoints;

Primary end point(s): Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).

Main Objective: • To examine the long term efficacy of CP 945,598 in prevention of weight regain in obese or overweight subjects over 12 months after previous weight loss (WL) induced by an 8 week low calorie diet (LCD)

Secondary ID(s)

2007-000703-15-DK

N/A

A5351028