Clinical trial NCT01195792 (phase 2, status: completed)
Conditions: obesity
ICD codes: E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: gsk1521498, placebo
SMILES: FC1=CC(=CC(F)=C1CNC1CC2=CC=CC=C2C1)C1=CC=CC(=C1)C1=NNC=N1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Obese but essentially healthy male or female between 18 and 60 years of age inclusive.

          -  Body Mass Index greater than or equal to 30 kg/m2.

          -  Binge Eating Scale (BES) score that is greater than or equal to 19 at screening
             assessment.

          -  A female subject of child-bearing potential must use one of the contraception methods
             listed in the protocol prior to the start of the study until at least 14 days after
             receiving the last dose of study medication.

          -  Male subjects must agree to use one of the contraception methods listed in the
             protocol from the time of the first dose of study medication until at least 5 days
             after receiving the last dose of study medication.

          -  Capable of giving written informed consent, which includes compliance with the
             requirements and restrictions listed in the information sheet or informed consent
             form. A good understanding of English is required due to the high number of
             questionnaires and assessments that subjects are required to undergo.

          -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2x Upper limit
             of Normal (ULN); alkaline phosphatase and bilirubin <1.5x (ULN) (isolated bilirubin
             >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

          -  Must be right handed (a requirement to ensure consistency of functional magnetic
             resonance imaging (fMRI) signals from the brain)

        Exclusion Criteria:

          -  Has a history of clinically significant medically diagnosed eating disorders
             (diagnosed and/or treated) as assessed by Diagnostic and Statistical Manual of Mental
             Disorders (DSM-IV/V) criteria using the Mini International Neuropsychiatric Interview
             (MINI).

          -  Self-administered Beck Depression Inventory II scale total score greater than 13 or
             suicide question score greater than zero at screening.

          -  Current history (in the last 6 months) of any Axis 1 psychiatric disorder as assessed
             by DSM-IV/V criteria using the MINI.

          -  Subject who, in the investigator/designee's judgement, poses a significant suicide
             risk. Evidence of serious suicide risk may include any history of suicidal behaviour
             and/or any evidence of suicidal ideation on any questionnaires e.g. type 4 or 5 on the
             Columbia Suicide Severity Rating Scale (C-SSRS) in the last 6 months.

          -  History of substance abuse or dependence in the 6 months prior to screening, as
             determined by the Investigator/designee or MINI.

          -  History of regular high level of alcohol consumption.

          -  Positive pre-study drug/alcohol screen.

          -  Smoking history that includes regular use of tobacco or nicotine-containing products
             within 3 months prior to screening

          -  Use of prohibited medications.

          -  use of prescription or non-prescription drugs, including vitamins, herbal and dietary
             supplements (including St John's Wort) within 14 days prior to the first dose of study
             medication.

          -  Subjects who do not currently show stable bodyweight, as judged by the PI/designee
             (e.g. >5% change within the last 3 months)

          -  Pregnant or lactating females

          -  Medical history, concurrent medical condition or laboratory result which makes the
             subject unsuitable for the study. This includes T1 or T2 diabetes mellitus (Fasting
             Blood Glucose (FBG) >7 mmol/L), untreated dyslipidaemia (fasting lipid profile with a
             Low Density Lipoprotein (LDL) cholesterol > 5 mmol/L), uncontrolled hypertension

          -  History of bariatric surgery for obesity.

          -  QTcB or QTcF > 450 msec.

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  Current or chronic history of neurological disorders.

          -  A positive test for HIV or Hepatitis C.

          -  Sleep apnoea

          -  Gastrointestinal disease including inflammatory bowel disease, chronic diarrhea,
             Crohn's or malabsorption syndromes within the past year

          -  Participated in a clinical trial and has received an investigational product within 90
             days.

          -  Any contraindications or logistical complications anticipated in relation to Magnetic
             Resonance Imaging (MRI) scanning or other endpoint assessments, including: presence of
             a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies,
             claustrophobia, inability to lie still on back, waist circumference of more than 170
             cm or body weight exceeding maximum capacity of MRI scanners (180 kg).

          -  Special dietary requirements (e.g. vegetarians, vegans, religious, food-intolerant
             diets).

          -  Unsuitable for cannulation.

          -  Subjects planning to start a calorie controlled diet or major exercise routine.

          -  Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days
             prior to the first dose of study medication