CompletedPhase 4Results posted

Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia

Lead sponsor

University of Massachusetts, Worcester

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Psychiatric (schizophrenia / bipolar / depression)

Eligibility highlights

Primary endpoint

•Negative Symptoms

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Exenatide

Who this study enrolls

Psychiatric (schizophrenia / bipolar / depression)

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

Group	Mean · score on a scale	95% CI
ExperimentalBaseline	33.1	-
Week 6	34.1	-
Week 12	35.8	-
Week 18	36.1	-
Week 24	35.2	-
PlaceboBaseline	34.1	-
Week 6	32.8	-
Week 12	34.5	-
Week 18	35.2	-
Week 24	35.0	-

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

Group	Mean · score on a scale	95% CI
ExperimentalBaseline	26.9	-
Week 6	27.3	-
Week 12	28.4	-
Week 18	28.7	-
Week 24	31.2	-
PlaceboBaseline	24.7	-
Week 6	27.2	-
Week 12	28.1	-
Week 18	32.2	-
Week 24	33.9	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.