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CompletedPhase 4Results posted

Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

70

actual

Study population

Psychiatric (schizophrenia / bipolar / depression)

Key I/E criterion

Primary endpoint

Negative Symptoms

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 IDNCT02417142
Org study ID13T-005

Timeline

Milestones

Study first posted2015-04-15estimated
Results first posted2021-06-15actual
Last update posted2022-01-14actual
Study start2014-09actual (month precision)
Primary completion2019-07actual (month precision)
Study completion2020-07actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Psychiatric (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 schizophrenia or schizoaffective disorder
stable dose of the current antipsychotic drug for at least one month
well established compliance with outpatient treatment per treating clinician's judgment
able to complete the cognitive assessment battery (must be English speaking)
Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study

Exclusion criteria

inability to provide informed consent
current substance abuse
psychiatrically unstable per treating clinician's judgment
significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases
currently on anti-inflammatory or immunosuppressant medication including oral steroids
currently on sulfonylurea drugs (e.g. glyburide)
history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition
pregnant or breastfeeding
prisoners

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.

Other clinical outcomes

2 endpoints
Primary/protocol endpoint/low confidence

Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score

Time frame:Baseline, Week 6, Week 12, Week 18 and Week 24

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
ExperimentalBaseline33.1
Week 634.1
Week 1235.8
Week 1836.1
Week 2435.2
PlaceboBaseline34.1
Week 632.8
Week 1234.5
Week 1835.2
Week 2435.0
Secondary/protocol endpoint

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score

Time frame:Baseline, Week 6, Week 12, Week 18, and Week 24.

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
ExperimentalBaseline26.9
Week 627.3
Week 1228.4
Week 1828.7
Week 2431.2
PlaceboBaseline24.7
Week 627.2
Week 1228.1
Week 1832.2
Week 2433.9

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.