ObesityPhase 2NCT01195792
A 35 Day Study to Investigate the Effects of GSK1521498 on Bodyweight in Obese Subjects With Over-Eating Behaviours.
A Phase 2 study testing GSK1521498 in people with Obesity, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese but otherwise healthy subjects with over-eating behaviours. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- GSK1521498
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2010to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
GSK Investigational Site
Birmingham, West Midlands, B15 3ES
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ
GSK Investigational Site
London, NW10 7EW
About this study
Official title: 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.
The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese but otherwise healthy subjects with over-eating behaviours.
Read the detailed description
This study is to test a new drug which may be used for treating over-eating behaviours and patterns that some overweight and obese people find difficult to control. The drug works by inhibiting the effects of messenger molecules called opioids. These opioids are naturally produced within the human body, and are involved in controlling how much we eat, and the pleasure we get from eating. We believe that GSK1521498 might be effective in the treatment of obesity because it is well known that drugs working on similar binding sites in the brain reduce the pleasure we get from eating, especially high fat or high sugar food. We also believe the effects of GSK1521498 will be greater in obese individuals with greater severity of over-eating behaviours, as measured for example by existing questionnaire scales for binge-eating or compulsive eating behaviour. We will perform a variety of simple tests using a computer, questionnaires and eating assessments to examine effects on behaviour. We will also ask people to complete questionnaires so that we can see if there are any effects on their mood.
- Conditions
- Obesity
- Being tested
- GSK1521498, Placebo
- Keywords
- Opioid receptors, Body weight, Over-eating behaviour, Obesity, Fat mass
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1521498Drug
GSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly
PlaceboDrug
Placebo will be given for up to 35 days and subjects will be assessed weekly
| Study group | Role | What they receive |
|---|---|---|
| 2 mg GSK1521498 | Experimental | Approximately 20 subjects will be randomised to receive 2 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods Receives: Drug: GSK1521498 |
| 5 mg GSK1521498 | Experimental | Approximately 20 subjects will be randomised to receive 5 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods Receives: Drug: GSK1521498 |
| Placebo | Placebo comparator | Approximately 20 subjects will be randomised to receive matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically and statistically significant weight loss
Measured: 35 days
Secondary outcomes (4)
To see if effects on bodyweight are associated with effects on fat mass, eating behaviour brain function and blood and urine markers
Measured: 35 days
To see if effects on bodyweight correlate with over-eating behaviour at baseline
Measured: 35 days
Safety: adverse events,blood pressure, heart rate, ECG, clinical chemistry, hematology, urinalysis, change in cognition (eg reaction times), change in mood scales, change in neuropsychiatric symptoms
Measured: 35 days
Pharmacokinetic/Pharmacodynamic (PK/PD) relationships: effects on primary and secondary outcomes, including estimation of possible dose-response relationships
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195792
- Sponsor's protocol ID
- 111850
- Status last verified
- Nov 2016
- First submitted
- 3 Sep 2010
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Chamberlain SR, Mogg K, Bradley BP, Koch A, Dodds CM, Tao WX, Maltby K, Sarai B, Napolitano A, Richards DB, Bullmore ET, Nathan PJ. Effects of mu opioid receptor antagonism on cognition in obese binge-eating individuals. Psychopharmacology (Berl). 2012 Dec;224(4):501-9. doi: 10.1007/s00213-012-2778-x. Epub 2012 Jul 3.
PubMed 22752384Ziauddeen H, Chamberlain SR, Nathan PJ, Koch A, Maltby K, Bush M, Tao WX, Napolitano A, Skeggs AL, Brooke AC, Cheke L, Clayton NS, Sadaf Farooqi I, O'Rahilly S, Waterworth D, Song K, Hosking L, Richards DB, Fletcher PC, Bullmore ET. Effects of the mu-opioid receptor antagonist GSK1521498 on hedonic and consummatory eating behaviour: a proof of mechanism study in binge-eating obese subjects. Mol Psychiatry. 2013 Dec;18(12):1287-93. doi: 10.1038/mp.2012.154. Epub 2012 Nov 13.
PubMed 23147384Cambridge VC, Ziauddeen H, Nathan PJ, Subramaniam N, Dodds C, Chamberlain SR, Koch A, Maltby K, Skeggs AL, Napolitano A, Farooqi IS, Bullmore ET, Fletcher PC. Neural and behavioral effects of a novel mu opioid receptor antagonist in binge-eating obese people. Biol Psychiatry. 2013 May 1;73(9):887-94. doi: 10.1016/j.biopsych.2012.10.022. Epub 2012 Dec 14.
PubMed 23245760
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01195792
- Acronym / sponsor ID
- 111850
- Conditions
- Obesity
- Keywords
- Opioid receptors, Body weight, Over-eating behaviour, Obesity, Fat mass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese but otherwise healthy subjects with over-eating behaviours.
Detailed description
This study is to test a new drug which may be used for treating over-eating behaviours and patterns that some overweight and obese people find difficult to control. The drug works by inhibiting the effects of messenger molecules called opioids. These opioids are naturally produced within the human body, and are involved in controlling how much we eat, and the pleasure we get from eating. We believe that GSK1521498 might be effective in the treatment of obesity because it is well known that drugs working on similar binding sites in the brain reduce the pleasure we get from eating, especially high fat or high sugar food. We also believe the effects of GSK1521498 will be greater in obese individuals with greater severity of over-eating behaviours, as measured for example by existing questionnaire scales for binge-eating or compulsive eating behaviour. We will perform a variety of simple tests using a computer, questionnaires and eating assessments to examine effects on behaviour. We will also ask people to complete questionnaires so that we can see if there are any effects on their mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 mg GSK1521498 | Experimental | Drug: GSK1521498Approximately 20 subjects will be randomised to receive 2 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods |
| 5 mg GSK1521498 | Experimental | Drug: GSK1521498Approximately 20 subjects will be randomised to receive 5 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods |
| Placebo | Placebo comparator | Drug: PlaceboApproximately 20 subjects will be randomised to receive matching placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1521498GSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly | Drug | 2 mg GSK1521498, 5 mg GSK1521498 |
| PlaceboPlacebo will be given for up to 35 days and subjects will be assessed weekly | Drug | Placebo |
Primary outcome
Clinically and statistically significant weight loss
Time frame: 35 days
4 secondary outcomes
To see if effects on bodyweight are associated with effects on fat mass, eating behaviour brain function and blood and urine markers
Time frame: 35 days
To see if effects on bodyweight correlate with over-eating behaviour at baseline
Time frame: 35 days
Safety: adverse events,blood pressure, heart rate, ECG, clinical chemistry, hematology, urinalysis, change in cognition (eg reaction times), change in mood scales, change in neuropsychiatric symptoms
Time frame: 35 days
Pharmacokinetic/Pharmacodynamic (PK/PD) relationships: effects on primary and secondary outcomes, including estimation of possible dose-response relationships
Time frame: 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Background: PubMed 22752384Chamberlain SR, Mogg K, Bradley BP, Koch A, Dodds CM, Tao WX, Maltby K, Sarai B, Napolitano A, Richards DB, Bullmore ET, Nathan PJ. Effects of mu opioid receptor antagonism on cognition in obese binge-eating individuals. Psychopharmacology (Berl). 2012 Dec;224(4):501-9. doi: 10.1007/s00213-012-2778-x. Epub 2012 Jul 3.
- Background: PubMed 23147384Ziauddeen H, Chamberlain SR, Nathan PJ, Koch A, Maltby K, Bush M, Tao WX, Napolitano A, Skeggs AL, Brooke AC, Cheke L, Clayton NS, Sadaf Farooqi I, O'Rahilly S, Waterworth D, Song K, Hosking L, Richards DB, Fletcher PC, Bullmore ET. Effects of the mu-opioid receptor antagonist GSK1521498 on hedonic and consummatory eating behaviour: a proof of mechanism study in binge-eating obese subjects. Mol Psychiatry. 2013 Dec;18(12):1287-93. doi: 10.1038/mp.2012.154. Epub 2012 Nov 13.
- Derived from this study: PubMed 23245760Cambridge VC, Ziauddeen H, Nathan PJ, Subramaniam N, Dodds C, Chamberlain SR, Koch A, Maltby K, Skeggs AL, Napolitano A, Farooqi IS, Bullmore ET, Fletcher PC. Neural and behavioral effects of a novel mu opioid receptor antagonist in binge-eating obese people. Biol Psychiatry. 2013 May 1;73(9):887-94. doi: 10.1016/j.biopsych.2012.10.022. Epub 2012 Dec 14.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK1521498 in people with Obesity, run by GlaxoSmithKline at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically and statistically significant weight loss (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195792, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.