A study testing whether a GLP-1 medicine, semaglutide, can help people with bipolar I disorder lose weight.

Recruiting now. Registry record last updated March 11, 2026.

Who can join
Adults 18 to 65, have bipolar I disorder, BMI 27+.
What you take
Semaglutide, given as part of the study. Check ClinicalTrials.gov for this trial's study groups, including any placebo or comparison medicine.
How long it lasts
The full study runs about 3 years.
What you get
Costs vary by study. Ask the study team what this one covers, including the study medicine, visits and travel, before you sign the consent form.
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Phase Phase 4Sponsor Mayo ClinicDrug semaglutideClass GLP-1 RASites 1 USEnrollment target 100

What this study is for

Primary condition: Bipolar I Disorder. Also studied in: Bipolar II Disorder, Schizo Affective Disorder, Obesity, Weight Loss, GLP - 1.

Full scientific study title: Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder.

Who can join

Age18 to 65SexAnyBMI27 or higher

Adults 18 to 65, have bipolar I disorder, BMI 27+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.

Full medical eligibility (for you and your doctor)verbatim from the registry

This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.

Key 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)

Key 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.

Where this trial is enrolling

This trial has 1 sites across 1 state. Contact a site coordinator directly to start screening.

Minnesota1 site

Timeline

Started enrolling: January 19, 2026. Expected completion: February 1, 2029. Last updated on ClinicalTrials.gov: March 11, 2026.

Official source

Every Monday we check this trial against ClinicalTrials.gov, the federal registry for clinical research. Last checked September 4, 2026. Confirm the current status there before you contact a site:

View on ClinicalTrials.gov →

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