DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01794429

TAO

CompletedPhase 3

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

Lead sponsor

Bjorn H. Ebdrup

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

45

actual

Study population

Obesity / overweight, Psychiatric (schizophrenia / bipolar / depression)

Key I/E criteria

•BMI ≥30•HbA1c ≤6.5%

Primary endpoint

•Weight loss

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01794429
Org study IDEudraCT nr: 2012-005404-17

Timeline

Milestones

Study first posted2013-02-18estimated
Last update posted2015-06-24estimated
Study start2013-02 (month precision)
Primary completion2015-06actual (month precision)
Study completion2015-06actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightPsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

•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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

2 endpoints
Primary/protocol endpoint

Weight loss

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:3 months

Total fat mass

change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.