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UnknownPhase NA

The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

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

Key I/E criterion

BMI ≥28

Primary endpoints

WeightConcentration of blood glucose in bloodTotal cholesterol, change

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 IDNCT06331286
Org study IDIIT20230091C-R1

Timeline

Milestones

Study start2023-09-01actual
Study first posted2024-03-26actual
Last update posted2024-03-26actual
Primary completion2024-12-31estimated
Study completion2024-12-31estimated

Assets

Investigational agents

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

a. Patients (or their legal representatives/guardians) sign off-label medication and informed consent; b. 16≤ age≤ 65 years old, gender is not limited; c. Patients in the stable phase who meet the diagnostic criteria for DSM-V bipolar disorder using a short-form international neuropsychiatric interview and have kept their current medication unchanged for at least 2 months after enrollment; Body mass index (BMI) ≥28 kg/m2 ;e. Young's Mania Scale (YMRS) ≤6 points; f. HAMD-24<8 points; Han Chinese; Completed compulsory education at or above junior high school;

Exclusion criteria

Subjects related: a. Patients who have undergone ECT therapy within 3 months; b. Have a hearing problem (inability to hear or understand the examiner's speech under normal conversation); c. Pregnant, lactating women or planning to become pregnant; d. Those who are allergic to the study drug.

Lesion-related: a. History of loss of consciousness due to cerebral organic disease or head trauma; b. Patients with any significant or unstable history of cardiovascular, respiratory, neurological (including epilepsy or significant cerebrovascular disease), renal, hepatic, or immune diseases, including inflammatory bowel disease, thyroid cancer, acute pancreatitis, etc., who are taking sulfonylurea drugs, anti-inflammatory or immunological agents, etc., especially those with a personal history or family history of medullary thyroid cancer (MTC) or 2 Patients with multiple endocrine neoplasia syndrome (MEN 2); c. Known, clinically significant laboratory markers or ECG abnormalities; Has any disease, liver disease, or renal disease that may alter the absorption, metabolism, or excretion of the study drug; d. Those with severe suicidal ideation and behavior or MARDS ≥ 30 points.

Exclusion criteria related to concomitant medications: a. chronic use of anticholinergics; b. history of psychoactive substance abuse and dependence;

Endpoints (9)

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

Cardiometabolic biomarkers
4
Other clinical outcomes
2
Weight & body composition
1
Glycemic / diabetes
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

weight

Time frame:Baseline, the end of Week 12 and the end of Week 24

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Concentration of blood glucose in blood

Time frame:Baseline, the end of Week 12 and the end of Week 24

descriptive

Cardiometabolic biomarkers

4 endpoints
Primary/protocol endpoint

Concentration of total cholesterol in blood

Time frame:Baseline, the end of Week 12 and the end of Week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Primary/protocol endpoint

Concentration of high density lipoprotein in blood

Time frame:Baseline, the end of Week 12 and the end of Week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Primary/protocol endpoint

Concentration of low density lipoprotein in blood

Time frame:Baseline, the end of Week 12 and the end of Week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Primary/protocol endpoint

Concentration of triglyceride in blood

Time frame:Baseline, the end of Week 12 and the end of Week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Treatment Emergent Symptom Scale (TESS) Score

Time frame:Time Frame: Baseline, the end of Week 2, 4, 8,12,16 and 24

descriptive

Other clinical outcomes

2 endpoints
Primary/protocol endpoint/low confidence

CBCT test results

Time frame:Baseline, the end of Week 12 and the end of Week 24

change from baseline, improvement

Secondary/protocol endpoint

17-item Hamilton Depression Rating Scale (HAM-D17) Score

Time frame:Time Frame: Baseline, the end of Week 2, 4, 8,12,16 and 24

change from baseline, improvement

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.