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

NCT01794429 | Completed Phase 3 DMC

• 1 other identifier: EudraCT nr: 2012-005404-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity; Metabolic Syndrome X; Drug-induced Obesity; Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Weight loss

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

  3 months

Secondary Outcomes (1)

• Effects of GLP-1-analogue treatment on body fat composition

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subcutaneum injection of placebo once-weekly for 3 months

Drug: Placebo

exenatide

ACTIVE COMPARATOR

Subcutaneum injection of exenatide once-weekly for 3 months

Drug: Exenatide

Interventions

Exenatide DRUG

Subcutaneum injection of exenatide once-weekly for 3 months

Also known as: Bydureon

exenatide

Placebo DRUG

Subcutaneum injection of placebo once-weekly for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• Bjorn H. Ebdrup: lead

Study Sites (1)

Cnsr/Cins

Glostrup Municipality, 2600, Denmark

Location

Related Publications (3)

• 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.

  PMID: 28260235 DERIVED

• 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.

  PMID: 27717222 DERIVED

• 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.

  PMID: 24401727 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Schizophrenia

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Pelle L Ishøy, MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PHD

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 18, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

DK (1)