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The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity
Lead sponsor
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
•Weight•Concentration of blood glucose in blood•Total 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointweight
Time frame:Baseline, the end of Week 12 and the end of Week 24
change from baseline, improvement
Glycemic / diabetes
1 endpointConcentration of blood glucose in blood
Time frame:Baseline, the end of Week 12 and the end of Week 24
descriptive
Cardiometabolic biomarkers
4 endpointsConcentration 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
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
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
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 endpointTreatment 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 endpointsCBCT test results
Time frame:Baseline, the end of Week 12 and the end of Week 24
change from baseline, improvement
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 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.