ObesityPhase 3TAONCT01794429
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
A Phase 3 study testing Exenatide in people with Obesity and Metabolic Syndrome X, run by Bjorn H. Ebdrup at 1 site in Denmark.
Trial summary
To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Metabolic Syndrome X, Drug-induced Obesity
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Jun 2015
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 65 years
- Diagnosis of the schizophrenia spectrum (ICD-10: F20.x, F25.x)both in-patients and out-patients will be included
- Current and unchanged treatment with at least one antipsychotic drug (FGA and/or SGA and/or depot treatment)
- BMI ≥30 kg/m2
- HbA1c < 6,5 %
Who cannot join
- Substance dependence (ICD-10: F1x.2 (apart from nicotine addiction F17.2))
- Diabetes or HbA1c ≥6.5%
- Contraindications to MRI (metal implants, pacemakers, severe claustrophobia, ≥150 kg (max. bed weight in the MRI scanner))
- Previous head trauma with a loss of consciousness for more than 5 minutes
- Pregnancy (screened by urine human chorionic gonadotropin (hCG),lactation or no acceptance to use effective contraception during the intervention period
- Severe somatic disease, including inflammatory bowel disease and chronic ketoacidosis
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- Allergy to exenatide
- Coercive measures according the Danish Law of Psychiatry
- conditions that according to sponsor are not congruous with participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum.
The investigators will also examine possible associations between GLP-1 treatment and peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fMRI).
Read the detailed description
The primary endpoint is weight loss after 3 months of treatment with the GLP-1 analogue exenatide (Bydureon®).
Secondary endpoints comprise both physiological/metabolic parameters and cognitive measurements:
- Metabolic endpoints include amongst others: changes in body fat (DEXA-scan) and changes of the HbA1c(average blood glucose levels), cholesterol and triglycerides. Moreover physiological effects will be examined eg possible effect on central/peripheral bloodpressure and heart rate.
- Cerebral endpoints will be investigated via functional magnetic resonance imaging (fMRI); including potential neuroprotective effects of exenatide. The main focus is potential hippocampal volume changes and potential changes in cerebral blood flow. Functional MRI will provide this data and the images will be correlated to both cognitive tests and questionnaires.
- Cognitive endpoints comprise potential improvements in cognition with focus on specific memory tests (BACS, DART and Rey's Complex Figure) and possible improvements in subjective quality of life (questionnaires).
- Conditions
- Obesity, Metabolic Syndrome X, Drug-induced Obesity, Schizophrenia
- Being tested
- Exenatide, Placebo
- Keywords
- Obesity, The Metabolic Syndrome/disturbances, Drug-induced adipositas, Schizophrenia, GLP-1 analogue, cerebral effects
- Medical subject headings
- Obesity, Metabolic Syndrome, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Bydureon
Subcutaneum injection of exenatide once-weekly for 3 months
PlaceboDrug
Subcutaneum injection of placebo once-weekly for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subcutaneum injection of placebo once-weekly for 3 months Receives: Drug: Placebo |
| exenatide | Active comparator | Subcutaneum injection of exenatide once-weekly for 3 months Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.
Measured: 3 months
Secondary outcomes (1)
Effects of GLP-1-analogue treatment on body fat composition
The investigators will explore potential effects of GLP-1 analogue treatment on different peripheral metabolic parameters: mainly changes in body fat composition (measured by DEXA-scan) and effects on HbA1c, triglycerides and cholesterol.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bjorn H. Ebdrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bjorn H. Ebdrup, University of Copenhagen
- Investigators
- Pelle L Ishøy, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794429
- Sponsor's protocol ID
- EudraCT nr: 2012-005404-17
- Acronym
- TAO
- Status last verified
- Jun 2015
- First submitted
- 14 Feb 2013
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ishoy PL, Fagerlund B, Broberg BV, Bak N, Knop FK, Glenthoj BY, Ebdrup BH. No cognitive-enhancing effect of GLP-1 receptor agonism in antipsychotic-treated, obese patients with schizophrenia. Acta Psychiatr Scand. 2017 Jul;136(1):52-62. doi: 10.1111/acps.12711. Epub 2017 Mar 5.
PubMed 28260235Ishoy PL, Knop FK, Broberg BV, Bak N, Andersen UB, Jorgensen NR, Holst JJ, Glenthoj BY, Ebdrup BH. Effect of GLP-1 receptor agonist treatment on body weight in obese antipsychotic-treated patients with schizophrenia: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2017 Feb;19(2):162-171. doi: 10.1111/dom.12795. Epub 2016 Nov 14.
PubMed 27717222Ishoy PL, Knop FK, Broberg BV, Baandrup L, Fagerlund B, Jorgensen NR, Andersen UB, Rostrup E, Glenthoj BY, Ebdrup BH. Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist--protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study: the TAO study protocol. BMJ Open. 2014 Jan 8;4(1):e004158. doi: 10.1136/bmjopen-2013-004158.
PubMed 24401727
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
- ClinicalTrials.gov ID
- NCT01794429
- Acronym / sponsor ID
- TAO / EudraCT nr: 2012-005404-17
- Conditions
- Obesity, Metabolic Syndrome X, Drug-induced Obesity, Schizophrenia
- Keywords
- Obesity, The Metabolic Syndrome/disturbances, Drug-induced adipositas, Schizophrenia, GLP-1 analogue, cerebral effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bjorn H. EbdrupUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Feb 2013 (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.
To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum.
The investigators will also examine possible associations between GLP-1 treatment and peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fMRI).
Detailed description
The primary endpoint is weight loss after 3 months of treatment with the GLP-1 analogue exenatide (Bydureon®).
Secondary endpoints comprise both physiological/metabolic parameters and cognitive measurements:
- Metabolic endpoints include amongst others: changes in body fat (DEXA-scan) and changes of the HbA1c(average blood glucose levels), cholesterol and triglycerides. Moreover physiological effects will be examined eg possible effect on central/peripheral bloodpressure and heart rate.
- Cerebral endpoints will be investigated via functional magnetic resonance imaging (fMRI); including potential neuroprotective effects of exenatide. The main focus is potential hippocampal volume changes and potential changes in cerebral blood flow. Functional MRI will provide this data and the images will be correlated to both cognitive tests and questionnaires.
- Cognitive endpoints comprise potential improvements in cognition with focus on specific memory tests (BACS, DART and Rey's Complex Figure) and possible improvements in subjective quality of life (questionnaires).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneum injection of placebo once-weekly for 3 months |
| exenatide | Active comparator | Drug: ExenatideSubcutaneum injection of exenatide once-weekly for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 - 65 years
- Diagnosis of the schizophrenia spectrum (ICD-10: F20.x, F25.x)both in-patients and out-patients will be included
- Current and unchanged treatment with at least one antipsychotic drug (FGA and/or SGA and/or depot treatment)
- BMI ≥30 kg/m2
- HbA1c < 6,5 %
Key exclusion criteria (9 listed)
- Substance dependence (ICD-10: F1x.2 (apart from nicotine addiction F17.2))
- Diabetes or HbA1c ≥6.5%
- Contraindications to MRI (metal implants, pacemakers, severe claustrophobia, ≥150 kg (max. bed weight in the MRI scanner))
- Previous head trauma with a loss of consciousness for more than 5 minutes
- Pregnancy (screened by urine human chorionic gonadotropin (hCG),lactation or no acceptance to use effective contraception during the intervention period
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 |
|---|---|---|
| ExenatideAlso: BydureonSubcutaneum injection of exenatide once-weekly for 3 months | Drug | exenatide |
| PlaceboSubcutaneum injection of placebo once-weekly for 3 months | Drug | Placebo |
Primary outcome
Weight loss
Time frame: 3 months
The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.
1 secondary outcome
Effects of GLP-1-analogue treatment on body fat composition
Time frame: 3 months
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 24 Jun 2015.
- Derived from this study: PubMed 28260235Ishoy PL, Fagerlund B, Broberg BV, Bak N, Knop FK, Glenthoj BY, Ebdrup BH. No cognitive-enhancing effect of GLP-1 receptor agonism in antipsychotic-treated, obese patients with schizophrenia. Acta Psychiatr Scand. 2017 Jul;136(1):52-62. doi: 10.1111/acps.12711. Epub 2017 Mar 5.
- Derived from this study: PubMed 27717222Ishoy PL, Knop FK, Broberg BV, Bak N, Andersen UB, Jorgensen NR, Holst JJ, Glenthoj BY, Ebdrup BH. Effect of GLP-1 receptor agonist treatment on body weight in obese antipsychotic-treated patients with schizophrenia: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2017 Feb;19(2):162-171. doi: 10.1111/dom.12795. Epub 2016 Nov 14.
- Derived from this study: PubMed 24401727Ishoy PL, Knop FK, Broberg BV, Baandrup L, Fagerlund B, Jorgensen NR, Andersen UB, Rostrup E, Glenthoj BY, Ebdrup BH. Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist--protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study: the TAO study protocol. BMJ Open. 2014 Jan 8;4(1):e004158. doi: 10.1136/bmjopen-2013-004158.
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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.
Pelle L Ishøy, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exenatide in people with Obesity and Metabolic Syndrome X, run by Bjorn H. Ebdrup at 1 site in Denmark.
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 5 inclusion and 9 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Weight loss (time frame: 3 months). 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 NCT01794429, 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 24 Jun 2015.