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Mayo clinic tests tailored obesity drugs for bipolar patients

NCT ID NCT07213466

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether matching specific weight-loss medications (Wegovy, Contrave, or Qsymia) to a person's obesity type (e.g., 'hungry brain' or 'emotional hunger') helps people with bipolar disorder lose weight safely. One hundred adults with bipolar or schizoaffective disorder will take part in a 20-week program that includes group therapy and regular check-ins. The goal is to see if this personalized approach is feasible and well-tolerated.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide, naltrexone/bupropion, or phentermine/topiramate
What this could lead to
If successful, this could help doctors choose the right weight-loss medication for people with bipolar disorder, improving weight management without worsening mood symptoms.
What could go wrong
This is a small, early-phase feasibility study (100 people) with no placebo control for all groups. Results may not apply to everyone, and weight-loss drugs can cause side effects or interact with mood stabilizers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

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