Bipolar I DisorderPhase 4OBOE-MayoNCT07213466
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
A Phase 4 study testing Group Therapy Program, semaglutide and Phentermine-Topiramate in people with Bipolar I Disorder and Bipolar II Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder
- What is being tested?
- Group Therapy Program, semaglutide and Phentermine-Topiramate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2026to 1 Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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™).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Laura N Harper, 507-255-9352, harper.laura1@mayo.edu
Mark A Frye, M.D.
About this study
Official title: Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo
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:
- 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.
Read the detailed description
This is a single-site, open-label, non-randomized interventional pilot study evaluating a phenotype-guided pharmacological approach to obesity in adults with bipolar disorder (BD). The study aims to assess the distribution of obesity phenotypes and the efficacy, safety, and tolerability of individualized anti-obesity pharmacotherapy in this population. A total of 100 participants with BD and comorbid obesity will be enrolled and stratified into one of four obesity phenotypes: Hungry Brain (abnormal satiation), Hungry Gut (abnormal postprandial satiety), Emotional Hunger (emotional eating), and Slow Burn (low resting energy expenditure).
Participants will undergo comprehensive obesity phenotyping, including indirect calorimetry, gastric emptying scintigraphy, DEXA scans, ad libitum buffet meal testing, and validated behavioral questionnaires. Based on phenotype classification, participants will receive one of the following FDA-approved anti-obesity medications (AOMs): phentermine-topiramate ER (Qsymia®), semaglutide (Wegovy®), or naltrexone-bupropion ER (Contrave®). Participants with the Slow Burn phenotype will receive behavioral and lifestyle interventions only.
All participants will engage in a 12-week virtual behavioral intervention program led by a multidisciplinary team, including a psychologist and a registered dietitian. The program includes weekly group sessions focused on nutrition, physical activity, cognitive restructuring, and relapse prevention.
A comprehensive data safety monitoring plan (DSMP) is in place, including bi-monthly reviews by a multidisciplinary team. Adverse events (AEs) and serious adverse events (SAEs) will be monitored and reported per institutional and federal guidelines. Participants will be withdrawn from the study if they experience treatment-emergent mania, severe depression, suicidality, or other safety concerns.
The statistical analysis plan includes descriptive statistics, repeated measures models, and subgroup analyses by phenotype and BD subtype. Missing data will be handled using multiple imputation or maximum likelihood methods. No formal multiplicity adjustments will be applied due to the exploratory nature of the study.
This study addresses a critical gap in obesity treatment for individuals with serious mental illness by integrating precision medicine with psychiatric care. The findings will inform future randomized controlled trials and contribute to the development of personalized obesity interventions in psychiatric populations.
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder, Obesity, Weight Loss, GLP - 1
- Being tested
- Group Therapy Program, semaglutide, Phentermine-Topiramate, naltrexone and bupropion (combination)
- Medical subject headings
- Bipolar Disorder, Psychotic Disorders, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Therapy ProgramBehavioural
a 12-week group therapy program centered around weight loss and healthy eating.
semaglutideDrug
Brand name: Wegovy
Phentermine-TopiramateDrug
Brand name: Qsymia
naltrexone and bupropion (combination)Drug
Brand name: Contrave
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide (Wegovy) + Group Therapy Program | Experimental | 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. Receives: Behavioral: Group Therapy Program; Drug: semaglutide |
| Naltrexone/Bupropion (Contrave) + Group Therapy Program | Experimental | 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. Receives: Behavioral: Group Therapy Program; Drug: naltrexone and bupropion (combination) |
| Phentermine/Topiramate (Qsymia) + Group Therapy Program | Experimental | 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. Receives: Behavioral: Group Therapy Program; Drug: Phentermine-Topiramate |
| No Study Medication + Group Therapy Program | Experimental | By meeting the slow burn phenotype, participants will attend a 12-week group therapy session for the 16-week clinical trial. Receives: Behavioral: Group Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through the end of the 20-week intervention.
Secondary outcomes (7)
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.
Measured: From the start of intervention (week 0) through the end of intervention (week 20).
The feasibility and tolerability of anti-obesity medication (AOM) in patients with BD, assessed by adherence rates and reports on adverse events.
Measured: from the start of intervention (week 0) through the end of intervention (week 20).
Total body weight loss (in kilograms) from baseline to end point in patients with BD and obesity.
Measured: From the start of intervention (week 0) through the end of intervention (week 20).
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.
Measured: From the start of intervention (week 0) through the end of intervention (week 20).
Changes in metabolic parameters from baseline to end point in patients with BD.
Measured: From the start of intervention (week 0) through the end of intervention (week 20).
Changes in eating behavior from baseline to endpoint in patients with BD using validated questionnaires.
Measured: From the start of intervention (week 0) through the end of intervention (week 20).
Changes in mood symptoms from baseline to endpoint in patients with BD using validated questionnaires.
Measured: From the start of intervention (week 0) through the end of intervention (week 20).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start19 Jan 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Mark Frye, Mayo Clinic
- Investigators
- Mark A Frye, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213466
- Sponsor's protocol ID
- 25-005856
- Acronym
- OBOE-Mayo
- Status last verified
- Mar 2026
- First submitted
- 23 Sep 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo
- ClinicalTrials.gov ID
- NCT07213466
- Acronym / sponsor ID
- OBOE-Mayo / 25-005856
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder, Obesity, Weight Loss, GLP - 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
This is a single-site, open-label, non-randomized interventional pilot study evaluating a phenotype-guided pharmacological approach to obesity in adults with bipolar disorder (BD). The study aims to assess the distribution of obesity phenotypes and the efficacy, safety, and tolerability of individualized anti-obesity pharmacotherapy in this population. A total of 100 participants with BD and comorbid obesity will be enrolled and stratified into one of four obesity phenotypes: Hungry Brain (abnormal satiation), Hungry Gut (abnormal postprandial satiety), Emotional Hunger (emotional eating), and Slow Burn (low resting energy expenditure).
Participants will undergo comprehensive obesity phenotyping, including indirect calorimetry, gastric emptying scintigraphy, DEXA scans, ad libitum buffet meal testing, and validated behavioral questionnaires. Based on phenotype classification, participants will receive one of the following FDA-approved anti-obesity medications (AOMs): phentermine-topiramate ER (Qsymia®), semaglutide (Wegovy®), or naltrexone-bupropion ER (Contrave®). Participants with the Slow Burn phenotype will receive behavioral and lifestyle interventions only.
All participants will engage in a 12-week virtual behavioral intervention program led by a multidisciplinary team, including a psychologist and a registered dietitian. The program includes weekly group sessions focused on nutrition, physical activity, cognitive restructuring, and relapse prevention.
A comprehensive data safety monitoring plan (DSMP) is in place, including bi-monthly reviews by a multidisciplinary team. Adverse events (AEs) and serious adverse events (SAEs) will be monitored and reported per institutional and federal guidelines. Participants will be withdrawn from the study if they experience treatment-emergent mania, severe depression, suicidality, or other safety concerns.
The statistical analysis plan includes descriptive statistics, repeated measures models, and subgroup analyses by phenotype and BD subtype. Missing data will be handled using multiple imputation or maximum likelihood methods. No formal multiplicity adjustments will be applied due to the exploratory nature of the study.
This study addresses a critical gap in obesity treatment for individuals with serious mental illness by integrating precision medicine with psychiatric care. The findings will inform future randomized controlled trials and contribute to the development of personalized obesity interventions in psychiatric populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Semaglutide (Wegovy) + Group Therapy Program | Experimental | Behavioral: Group Therapy Program, Drug: semaglutideBy 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. |
| Naltrexone/Bupropion (Contrave) + Group Therapy Program | Experimental | Behavioral: Group Therapy Program, Drug: naltrexone and bupropion (combination)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. |
| Phentermine/Topiramate (Qsymia) + Group Therapy Program | Experimental | Behavioral: Group Therapy Program, Drug: Phentermine-TopiramateBy 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. |
| No Study Medication + Group Therapy Program | Experimental | Behavioral: Group Therapy ProgramBy meeting the slow burn phenotype, participants will attend a 12-week group therapy session for the 16-week clinical trial. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Therapy Programa 12-week group therapy program centered around weight loss and healthy eating. | Behavioural | Naltrexone/Bupropion (Contrave) + Group Therapy Program, No Study Medication + Group Therapy Program, Phentermine/Topiramate (Qsymia) + Group Therapy Program, Semaglutide (Wegovy) + Group Therapy Program |
| semaglutideBrand name: Wegovy | Drug | Semaglutide (Wegovy) + Group Therapy Program |
| Phentermine-TopiramateBrand name: Qsymia | Drug | Phentermine/Topiramate (Qsymia) + Group Therapy Program |
| naltrexone and bupropion (combination)Brand name: Contrave | Drug | Naltrexone/Bupropion (Contrave) + Group Therapy Program |
Primary outcome
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.
7 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark A Frye, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group Therapy Program, semaglutide and Phentermine-Topiramate in people with Bipolar I Disorder and Bipolar II Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura N Harper (507-255-9352, harper.laura1@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.