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OBOE-Mayo

RecruitingPhase 4

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo

Lead sponsor

Mayo Clinic

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

100

estimated

Study population

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

Key I/E criterion

•BMI ≥30

Primary endpoint

•Describe the distribution of obesity phenotypes

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 IDNCT07213466

Org study ID25-005856

Timeline

Milestones

Study first posted2025-10-09actual

Study start2026-01-19actual

Last update posted2026-03-11actual

Primary completion2028-02-01estimated

Study completion2029-02-01estimated

Assets

Investigational agents

Semaglutide

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

•Men or women between 18 to 65 years old.

•Patients with a SCID IV confirmed diagnosis of bipolar disorder (BDI or BDII) or schizoaffective bipolar type (SZA-BD).

•Women with a negative pregnancy test 48 hours before study entry (obesity phenotyping visit).

•Patients with a negative urine drug screen except for allowable drugs.

•Patients with a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 plus one medical comorbidity (e.g., type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea)

•Patients must be undergoing mood stabilizer treatment but may also receive concurrent antidepressant or anxiolytic therapy.

•Patients must be on a stable regimen of a mood stabilizer, with no changes to the medication, for at least one month prior to study enrollment.

•Continuation of mood-stabilizing treatment is preferred but not required; the decision should be made in collaboration with the participant's primary mental health provider.

Exclusion criteria

•Abdominal bariatric surgery: Gastric bypass surgery (Roux-en-Y), Adjustable gastric band (Lap band), and Gastric sleeve surgery (Sleeve gastrectomy).

•Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, such as diabetic gastroparesis; or use of medications that may alter gastrointestinal motility and appetite.

•Positive history of chronic gastrointestinal diseases that could affect gastrointestinal absorption such as inflammatory bowel disease (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), etc; or use of medications that may alter gastrointestinal absorption.

•Significant untreated psychiatric dysfunction.

•Hypersensitivity to any of the study medications.

•Contraindications to the FDA-approved medications: Phentermine-Topiramate Extended Release; Oral naltrexone extended-release/bupropion extended-release (NBSR; Contrave®, Mysimba™); and Semaglutide (Weygovy™).

•Inability to provide informed consent: participants who are on involuntary commitment, conservatorship or under a legal guardian.

•Patients with active hypomania or mania (YMRS ≥ 20 points)

•Patients with active psychosis (YMRS item 8 ≥ 6 points)

•Patients with active suicide ideation (MADRS item 10 ≥ 4 points)

•Patients with any medication changes (mood stabilizers) without advisement of study clinicians or clinical provider.

•Patients with active bulimia (purging) or anorexia (severe restriction)

•Patients with a history of bulimia (purging behaviors) or anorexia (severe dietary restriction) within the 12 months preceding study enrollment will be excluded

•Current drug and/or alcohol use disorders (except nicotine)

•Patients with a positive toxicology screening (except cannabis)

•Positive toxicology screen for cannabis and a cannabis use disorder by CUDIT-R.

•Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less.

•Patients unwilling to complete the full phenotyping day on its current form (i.e. patients avoiding gluten meal or adhering to a vegan diet).

Endpoints (11)

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

Other (unclassified)

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Total body weight loss (in kilograms) from baseline to end point in patients with BD and obesity.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20).

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

The proportion of treatment responders, defined as individuals achieving >4% total body weight loss, from baseline to end point in patients with BD and obesity.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20).

threshold achievement, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Changes in eating behavior from baseline to endpoint in patients with BD using validated questionnaires.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20).

change from baseline, improvement

Secondary/protocol endpoint

Changes in mood symptoms from baseline to endpoint in patients with BD using validated questionnaires.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20).

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint/low confidence

The feasibility and tolerability of anti-obesity medication (AOM) in patients with BD, assessed by adherence rates and reports on adverse events.

Time frame:from the start of intervention (week 0) through the end of intervention (week 20).

descriptive

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Describe the distribution of obesity phenotypes (hungry brain, hungry gut, emotional hunger and slow burn) in patients with BD and obesity, with the goal of identifying predominant phenotype patterns within this clinical population.

Time frame:From enrollment through the end of the 20-week intervention.

descriptive

Secondary/protocol endpoint

Compare the distribution of obesity phenotypes (hungry brain, hungry gut, emotional hunger, and slow burn) in patients with BD and obesity and non-BD participants published in previously cohorts.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20).

descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Changes in metabolic parameters from baseline to end point in patients with BD.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20).

change from baseline, improvement

Other/protocol endpoint/low confidence

Changes in mitochondrial biomarkers from baseline to end point in patients with BD and obesity.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Changes in stress related biomarkers from baseline to end point in patients with BD and obesity.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20)

change from baseline, improvement

Other/protocol endpoint/low confidence

Surrogate biomarkers of obesity phenotypes.

Time frame:From the start of intervention (week 0) through the end of intervention (week 20).

descriptive

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.