Taking people in United StatesPhase 4

Tests weight loss medicines in adults with bipolar disorder and obesity

Compares weight loss medicines and group therapy in adults with bipolar disorder and obesity.

Key facts

Who runs it: Mayo Clinic
Where: Rochester, United StatesSee the site
Trial code: NCT07213466
Registry title: Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
Status: Recruiting
Phase: Phase 4
People taking part: 100 people, planned
Started: 19 Jan 2026
Expected to end: 1 Feb 2029
Type of study: Interventional, 4 groups
Treatments tested: Group Therapy Program
semaglutide
Phentermine-Topiramate
naltrexone and bupropion (combination)
Record updated: 11 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with bipolar disorder (or schizoaffective bipolar type) and obesity, who take a stable mood stabilizer. It tests weight-loss medication plus group therapy.

Age: 18 to 65 years
Sex: Men and women can join.
Disease stage: Bipolar I, bipolar II or schizoaffective bipolar type, confirmed by a diagnostic interview (SCID IV). BMI of 30 kg/m2 or more, or BMI of 27 kg/m2 or more plus one medical condition such as type 2 diabetes, high blood pressure, high blood fats or sleep apnea.
Earlier treatment: Must be on a mood stabilizer with no changes for at least one month before enrolment. An antidepressant or anxiety medicine may be taken too. No past stomach surgery for weight loss.
Biomarker or test result: Women need a negative pregnancy test 48 hours before study entry. A urine drug screen must be negative, except for allowed drugs.

Main reasons for not taking part

Gastric bypass, gastric band or gastric sleeve surgery
Long-term gut disease or medicines that change gut movement, appetite or absorption
Active mania or hypomania, active psychosis or active suicidal thoughts
Current drug or alcohol use disorder (except nicotine), or active or recent bulimia or anorexia
Allergy or a medical reason not to take the study medicines

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

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

Who cannot take part

Abdominal bariatric surgery: Gastric bypass surgery (Roux-en-Y), Adjustable gastric band (Lap band), and Gastric sleeve surgery (Sleeve gastrectomy)
Contraindications to the FDA-approved medications: Phentermine-Topiramate Extended Release; Oral naltrexone extended-release/bupropion extended-release (NBSR; Contrave®, Mysimba™); and Semaglutide (Weygovy™)
Patients with any medication changes (mood stabilizers) without advisement of study clinicians or clinical provider
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
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)
Positive toxicology screen for cannabis and a cannabis use disorder by CUDIT-R
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 active bulimia (purging) or anorexia (severe restriction)
Patients with a positive toxicology screening (except cannabis)
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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 65 years old?

Where in United States

Mayo ClinicRochester, United StatesContact: Laura N HarperTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are:

Read full original descriptionShow less

* Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)? * Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder?

Participation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone/Bupropion (Contrave®), or Phentermine/Topiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.

The 4 groups in the trial

Semaglutide (Wegovy) + Group Therapy ProgramTreatment being tested
By meeting the satiety/return to hunger (Hungry Gut) phenotype, participants will take Semaglutide (Wegovy) and attend a 12-week group therapy session for the 16-week clinical trial.
Treatment: Group Therapy Program and semaglutide
Naltrexone/Bupropion (Contrave) + Group Therapy ProgramTreatment being tested
By meeting the behavioral/psychological (Emotional Hunger) phenotype, participants will take Naltrexone/Bupropion (Contrave) and attend a 12-week group therapy session for the 16-week clinical trial.
Treatment: Group Therapy Program and naltrexone and bupropion (combination)
Phentermine/Topiramate (Qsymia) + Group Therapy ProgramTreatment being tested
By meeting the satiation (Hungry Brain) phenotype, participants will take Phentermine/Topiramate (Qsymia) and attend a 12-week group therapy session for the 16-week clinical trial.
Treatment: Group Therapy Program and Phentermine-Topiramate
No Study Medication + Group Therapy ProgramTreatment being tested
By meeting the slow burn phenotype, participants will attend a 12-week group therapy session for the 16-week clinical trial.
Treatment: Group Therapy Program