A 35-Day, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate the Effects of GSK1521498 on Body Weight and Composition, Eating Behaviour and Related Brain Function, in Obese Subjects with Over-Eating Behaviours.
- Conditions
- GSK1521498 is a novel opioid receptor inverse agonist that is being developed for the treatment of obesity.MedDRA version: 12.1Level: LLTClassification code 10029883Term: Obesity
- Registration Number
- EUCTR2009-016663-11-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Obese but essentially healthy male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent form.
2. Body Mass Index greater than or equal to 30 kg/m2. There is no upper limit on BMI subject to satisfaction of all other exclusion criteria.
3. Binge Eating Scale (BES) score that is greater than or equal to 19 at screening assessment.
4. A female subject of child-bearing potential is eligible to participate if she agrees to use an adequate contraception method for an appropriate period of time (as defined in the protocol) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 14 days after receiving the last dose of study medication.
5. Male subjects must agree to use an adequate contraception method from the time of the first dose of study medication until at least 5 days after receiving the last dose of study medication.
6. 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.
7. AST and ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
8. Must be right handed (a requirement to ensure consistency of fMRI signals from the brain)
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) no
F.1.3.1 Number of subjects for this age range
1. Subject has a history of clinically significant medically diagnosed eating disorders (diagnosed and/or treated) as assessed by DSM-IV/V criteria using the MINI.
2. Self-administered Beck Depression Inventory II scale total score greater than 13 or suicide question score greater than zero at screening.
3. Subject who have a current history (in the last 6 months) of any Axis 1 psychiatric disorder as assessed by DSM-IV/V criteria using the MINI.
4. 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 C-SSRS in the last 6 months.
5. Subject has a history of substance abuse or dependence in the 6 months prior to screening, as determined by the Investigator/designee or MINI.
6. Abuse of alcohol, defined for males, as an average weekly intake of greater than 21 units (or an average daily intake of greater than 3 units), or defined for females, as an average weekly intake of greater than 14 units (or an average daily intake of greater than 2 units). One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.
7. Positive urine screen for amphetamines, barbiturates, cocaine, opiates, cannabinoids or benzodiazepines at screening.
8. Smoking history that includes regular use of tobacco or nicotine-containing products within 3 months prior to screening
9. Subjects who do not currently show stable bodyweight, as judged by the PI/designee (e.g. >5% change within the last 3 months)
10. Pregnant or lactating females
11. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
12. Any contraindications or logistical complications anticipated in relation to MRI scanning or other endpoint assessments, in the judgment of the Principal Investigator, including: presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI questionnaire, 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). In some cases, at the discretion of the investigator, subjects with a waist circumference over 170 cm may be included in the study and will undergo all procedures except MRI scans.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method