Safety and Efficacy of Low Doses of V24343 in Obese Subjects
Safety and Efficacy of Low Doses of V24343 in Obese Subjects
Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo
 to study the effect of V24343 on blood pressure and weight in obese subjects.

 The primary variables, change in blood pressure (BP) and pulse, will be assessed both by
 outpatient ambulatory monitoring of vital signs and by regular clinic monitoring.

 The efficacy of V24343 will be assessed by measurement of body weight, waist circumference,
 bioimpedance assessment of body composition and blood glucose.

 Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing
 will be used to assess the pharmacokinetics of V24343.

 Other safety assessments comprise routine monitoring of adverse events; concomitant
 medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and
 self-completed psychiatric assessments.
Inclusion Criteria: Subjects must:

 -  be healthy male subjects aged 18 to 60 years

 -  have a body mass index greater than or equal to 27 kg/m2

 -  have a waist measurement >94 cm

 -  have blood pressure (BP) within the ranges systolic BP (SBP): 90-150 mmHg; diastolic
 BP (DBP): 40-90 mmHg, based on mean of day time readings recorded during a 24 hour
 period of ambulatory monitoring:

 -  be willing to use an effective method of contraception (condom with a spermicidal
 contraceptive, or sterilised) for the duration of the study and for 3 months after the
 last dose of study medication

 -  have an acceptable medical and social history in the 12 months prior to screening

 -  be able to comply with the requirements of the entire study

 -  give written informed consent

 Exclusion Criteria: Subjects must not:

 -  have received V24343 previously

 -  suffer from or have a history of anxiety or depression; have abnormal results on
 Patient Health Questionnaire 9 or Profile of Mood States (see Section 6.3.4.5)

 -  have a history of seizures (excluding febrile convulsions below 3 years of age)

 -  be male subjects whose female partners are trying to become pregnant within 3 months
 after the last dose of study medication

 -  have a significant medical condition or a history of such a condition that the
 Investigator considers should exclude the subject from the study

 -  have multiple drug allergies or be allergic to any of the components of V24343 study
 medication

 -  be smokers whom smoke more than 10 cigarettes per day

 -  consume more than 28 units of alcohol per week, or have a significant history of
 alcohol abuse

 -  have a positive test for alcohol or drugs of abuse at screening or admission to any of
 the treatment periods

 -  have donated blood or plasma in excess of 500 mL within 3 months of screening

 -  have been exposed to any new investigational agent within 3 months prior to study drug
 administration

 -  have clinically significant abnormalities on laboratory screening tests, particularly
 liver function and renal function tests (see Section 6.3.4.2)

 -  have clinically relevant abnormal physical findings on examination

 -  have clinically relevant abnormal findings on 12-lead ECG including a mean QTcB at
 screening ≥430 msec

 -  be seropositive for hepatitis B, hepatitis C or human immunodeficiency (HIV) viruses
 at screening

 -  have any medical or social reasons for not participating in the study raised by their
 General Practitioner/primary care physician

 -  have any other condition that might increase the risk to the individual or decrease
 the chance of obtaining satisfactory data, as assessed by the Investigator

 -  have had treatment with any prescription medicine within one month of first dose or
 any over-the-counter medicines, except for paracetamol, within one week of the first
 dose