DelfaGLP-1 Atlas

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GREAT

UnknownPhase 2

Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients?

Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients? A Randomized, Double-blinded, Placebo-controlled Clinical Trial

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

103

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance, Psychiatric (schizophrenia / bipolar / depression)

Key I/E criterion

•BMI ≥27

Primary endpoint

•Postprandial glucose

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 IDNCT01845259
Org study IDGLP-1 antipsychotics
Secondary ID2013-000121-31
Secondary IDU1111-1128-3404UTN-number

Timeline

Milestones

Study first posted2013-05-03estimated
Last update posted2016-05-05estimated
Study start2013-04 (month precision)
Primary completion2016-03actual (month precision)
Study completion2017-03estimated (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerancePsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Informed oral and written consent
•Diagnosed with schizophrenia, schizotypal disorder or paranoid psychosis according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)
•and on stable antipsychotic treatment with either clozapine or olanzapine for at least 6 months (without dose change for at least 30 days)
•Stable co-medications for at least 30 days.
•Age ≥18 years and ≤65 years
•Stable weight (defined as less than 5% change in weight over the last 3 month before inclusion)
•BMI ≥27 kg/m2
•Dysglycaemia (IFG, i.e. fasting plasma glucose level from 6.1 mmol/L to 6.9 mmol/L or IGT, i.e. two-hour glucose levels > 7.8 mmol/L on the 75-g oral glucose tolerance test with a fasting plasma glucose of less than 7.0 mmol/L and HbA1c < 48 mmol/mol or HbA1c: 43 mmol/mol ≤ HbA1c ≤ 47 mmol/mol)

Exclusion criteria

•Compulsory treatment
•Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
•Subjects treated with corticosteroids or other hormone therapy (except estrogens)
•Any active substance abuse or dependence for the past 6 months (except for nicotine)
•Impaired hepatic function (liver transaminases >2 times upper normal limit)
•Impaired renal function (se-creatinine >150 μM and/or macroalbuminuria)
•Impaired pancreatic function (acute or chronic pancreatitis and/or amylase >2 times upper normal limit)
•Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
•Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
•Any condition that the investigator feels would interfere with trial participation
•Receiving any investigational drug within the last 3 months
•Use of weight-lowering pharmacotherapy within the preceding 3 month
•Type 1 or 2 diabetes with HbA1c > 6.5%

Also a group of healthy controls (n=10) will have the baseline examinations done. The healthy controls will be matched to our participants in regards to gender, BMI and age. The same inclusion and exclusion criteria will apply for these controls, except these participants are not allowed to have known psychiatric illness, receive anti-psychotic medications, or have a family history of type 2 diabetes (2 generations).

Endpoints (14)

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.

Coverage by outcome category

Weight & body composition
3
Glycemic / diabetes
3
Other (unclassified)
3
Cardiometabolic biomarkers
2
Other clinical outcomes
2
Patient-reported / QoL
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Body weight

Time frame:Every 4 weeks from baseline - 16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Body composition

Time frame:Baseline - 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:Every 4 weeks from baseline - 16 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Glucose tolerance

Time frame:Baseline - 16 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Dysglycaemia

Time frame:Baseline - 16 weeks

categorical status, improvement

Secondary/protocol endpoint

Secretion of incretin hormons, insulin sensitivity and beta cell function

Time frame:Baseline - 16 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint/low confidence

Lipid profile and liver function

Time frame:Every 4 weeks from baseline - 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Blood pressure

Time frame:Every 4 weeks from baseline - 16 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Psychopathology

Time frame:Baseline - 16 weeks

change from baseline, improvement

Other clinical outcomes

2 endpoints
Other/protocol endpoint

Alcohol use

Time frame:Every 4 weeks from baseline - 16 weeks

AUDIT score

change from baseline, improvement

Other/protocol endpoint/low confidence

Changes i dietary and exercise records

Time frame:Every 4 weeks from baseline - 16 weeks

descriptive

Other (unclassified)

3 endpoints
Other/protocol endpoint/low confidence

Proteomic fingerprinting

Time frame:Every 4 weeks from baseline - 16 weeks

descriptive

Other/protocol endpoint/low confidence

Long term follow-up 52 weeks after end of participation

Time frame:52 weeks after 16 weeks of liraglutide/placebo-treatment

descriptive

Other/protocol endpoint/low confidence

Baseline comparisons with healthy controls (non-psychiatric, non-diabetic)

Time frame:Baseline examination

descriptive

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.