CompletedNCT01794429TAOUpdated Jun 24, 2015

Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

A Phase 3 interventional study of Exenatide and Placebo in Obesity, Metabolic Syndrome X and Drug-induced Obesity, sponsored by Bjorn H. Ebdrup. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-06-24.

Sponsored by Bjorn H. Ebdrup · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

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 studied

Obesity
Metabolic Syndrome X
Drug-induced Obesity
Schizophrenia

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Keywords

Obesity
The Metabolic Syndrome/disturbances
Drug-induced adipositas
Schizophrenia
GLP-1 analogue
cerebral effects

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 45 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

Bjorn H. Ebdrup is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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 %

Exclusion criteria

Exclusion Criteria:

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
Allergy to exenatide
Coercive measures according the Danish Law of Psychiatry
conditions that according to sponsor are not congruous with participation in the study

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 45 participants (actual)

Study arms

Placebo comparator
Placebo
Subcutaneum injection of placebo once-weekly for 3 months
Drug: Placebo
Active comparator
exenatide
Subcutaneum injection of exenatide once-weekly for 3 months
Drug: Exenatide

Interventions

DrugExenatide
Subcutaneum injection of exenatide once-weekly for 3 months
Also known as: Bydureon
DrugPlacebo
Subcutaneum injection of placebo once-weekly for 3 months

What researchers measure

Primary outcomes

Weight loss
The primary endpoint is weight loss after 3 months of treatment with a GLP-1 analogue.
Time frame: 3 months

Secondary outcomes

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.
Time frame: 3 months

Study locations

1 site

Cnsr/Cins
Glostrup, 2600, Denmark

References and documents

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 28260235 ↗
Ishoy 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. Erratum In: Diabetes Obes Metab. 2018 May;20(5):1327-1328. doi: 10.1111/dom.13204. PubMed 27717222 ↗
Ishoy 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01794429
Lead sponsor: Bjorn H. Ebdrup
Responsible party: Bjorn H. Ebdrup (MD PHD, University of Copenhagen) — Sponsor-investigator
First posted: Feb 18, 2013
Start date: Feb 2013
Primary completion: Jun 2015
Completion: Jun 2015
Last update: Jun 24, 2015

Study contacts

Pelle L Ishøy, MD

principal investigator · University of Copenhagen

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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