|E.1 Medical condition or disease under investigation
|E.1.1||Medical condition(s) being investigated ||
|E.1.2 Medical condition or disease under investigation
|E.1.2||Classification code ||10029883
|E.1.3||Condition being studied is a rare disease || No
|E.2 Objective of the trial
|E.2.1||Main objective of the trial ||
• Determine the effect of CP-945,598 on
• Percent change in body weight at year 1
• Proportion of subjects who lose 5% of body weight at year 1
|E.2.2||Secondary objectives of the trial ||
|• Determine the effect of CP-945,598 on:
• Percent change in body weight at Year 2;
• Proportion of subjects who lose 10% body weight at Year 1;
• Changes in waist circumference at Year 1;
• Changes in HDL and triglycerides at Year 1.
• Determine the effect of CP-945,598 on Changes in Patient Reported Outcome
Scales at 1 year:
• --Uncontrolled Eating
• --Power of Food
• Evaluate the safety and tolerability of CP-945,598 in a 2-year outpatient setting,
• Explore the effect of CP-945,598 on:
• Waist circumference;
• Proportion of subjects who lose 5 and 10% body weight;
• Sun/Artificial light related adverse event monitoring;
• Pharmacodynamic measurements
• Prevalence of metabolic syndrome;
• Patient Reported Outcomes;
• pharmacokinetics of CP-945,598
• Explore PK/PD relationships between CP-945,598 exposure and changes in body
|E.2.3||Trial contains a sub-study || No
|E.3||Principal inclusion criteria ||
|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 be
postmenopausal or must agree to use effective contraception during the study.
Oral contraceptive use is permitted if used for at least 3 months before starting
3. Male subjects must be surgically sterile or must use effective contraception during
Note: The definition of effective contraception for both women and men will be based on the judgment of the Investigator or a designated associate.
4. Body Mass Index (BMI) NLT 30 kg/m2, for subjects without co-morbidities; NLT 27 kg/m2
for subjects with co-morbidities (treated or untreated hypertension and/or
treated or untreated dyslipidemia):
A. Hypertension is defined as:
a. Systolic BP NLT 140 and/or diastolic BP NLT 90 mm Hg and/or,
b. On anti-hypertensive medication.
B. Dyslipidemia is defined as:
a. LDL-C not at goal according to local guidelines and/or,
b. Triglycerides NLT 150 mg/dL and/or,
c. HDL-C < 40 mg/dL 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.
5. 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.
6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other trial procedures.
|E.4||Principal exclusion criteria||
|1. Women who are pregnant or lactating, or who are actively planning to become
2. Subjects with clinically significant abnormalities identified during the screening
process. Specific exclusions include the following:
a. Subjects with clinically significant cardiovascular disease, defined 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.
b. Subjects with systolic BP NLT 160 and/or diastolic BP NLT 100 mm Hg or requiring new
pharmacological treatment or change in current treatment according to local
c. Subjects with dyslipidemia requiring new pharmacological treatment or change in
current treatment according to local guidelines.
d. Subjects with diabetes or fasting blood glucose concentration NLT 126 mg/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
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 NLT 2 times the ULN.
h. History of HIV infection or use of anti-retroviral agents.
i. Subjects with any prior history of malignancy except for:
• Basal cell carcinoma of the skin curatively treated,
• 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 prior to screening, defined as requiring hospitalization, two or
more episodes of a major depressive disorder or 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.
• Subjects with a score of NLT 10 or who score positively on the item 9 addressing
suicidal ideas on the PHQ-9.
• Subjects with psychotic conditions or on antipsychotic pharmacotherapy.
• Subjects with seizure disorders who:
1. Are not controlled by current antiepileptic treatment,
2. Are taking antiepileptic drugs (AEDs) known to affect weight positively (eg,
valproic acid) or negatively (eg, topiramate, zonisamide) unless these
medications have been taken at a stable dose for at least 6 months and the
subject’s weight has been stable over the same time period.
• Subjects with neurological disorders that are acute, chronic relapsing, progressive
or have an unpredictable course.
3. Subjects who frequently change smoking habits or have stopped smoking within 6
months prior to screening.
4. Subjects who use marijuana (determined by medical history).
5. Subjects with known history of alcoholism or drug abuse or dependence within 1
year prior to screening.
6. Subjects with a history of anorexia, bulimia nervosa or binge eating disorder as
per DSM-IV TR.
7. Participation in any formal weight loss program within the 3 months prior to
8. Fluctuation in body weight > 5% within 3 months prior to screening.
9. Failure to satisfactorily complete at least 5 of the 7-day food intake and/or physical
10. Use of prescription drugs or over the counter agents/supplements known to alter
body weight or appetite within 3 months prior to screening.
11. Systemic therapy with strong CYP3A inhibitors.
12. Systemic therapy with clinically significant CYP3A inducers or regular consumption
of grapefruit/grapefruit juice.
13. Treatment with an investigational drug during the 30 days prior to screening.
14. Subjects with any other medical condition or laboratory abnormality prior to
randomization, which in the opinion of the investigator or sponsor could affect
subject safety, preclude evaluation of response, or render unlikely that the
subject would complete the study.
|E.5 End points
|E.5.1||Primary end point(s)||
|Percent change in body weight from baseline (Day 1) to end of 1 year and year 2
|E.6 and E.7 Scope of the trial
|E.6||Scope of the trial
|E.6.9||Dose response|| No
|E.6.13.1||Other scope of the trial description||
|Patient Reported Outcomes
|E.7||Trial type and phase
|E.7.1||Human pharmacology (Phase I)|| No
|E.7.1.1||First administration to humans|| Information not present in EudraCT
|E.7.1.2||Bioequivalence study|| Information not present in EudraCT
|E.7.1.3||Other|| Information not present in EudraCT
|E.188.8.131.52||Other trial type description||
|E.7.2||Therapeutic exploratory (Phase II)|| No
|E.7.3||Therapeutic confirmatory (Phase III)|| Yes
|E.7.4||Therapeutic use (Phase IV)|| No
|E.8 Design of the trial
|E.8.1.3||Single blind|| No
|E.8.1.4||Double blind || Yes
|E.8.1.5||Parallel group|| Yes
|E.8.1.6||Cross over || No
|E.8.2|| Comparator of controlled trial
|E.8.2.1||Other medicinal product(s)|| No
|E.8.2.2||Placebo || Yes
The trial involves single site in the Member State concerned
|E.8.4|| The trial involves multiple sites in the Member State concerned || Yes
|E.8.4.1||Number of sites anticipated in Member State concerned||5
|E.8.5||The trial involves multiple Member States|| Yes
|E.8.5.1||Number of sites anticipated in the EEA||31
|E.8.6 Trial involving sites outside the EEA
|E.8.6.1||Trial being conducted both within and outside the EEA|| Yes
|E.8.6.2||Trial being conducted completely outside of the EEA|| Information not present in EudraCT
|E.8.6.3||If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned||
|E.8.7||Trial has a data monitoring committee|| Yes
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|E.8.9 Initial estimate of the duration of the trial
|E.8.9.1||In the Member State concerned years||2
|E.8.9.1||In the Member State concerned months||11
|E.8.9.1||In the Member State concerned days||
|E.8.9.2||In all countries concerned by the trial years||2
|E.8.9.2||In all countries concerned by the trial months||11