Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide for fat loss, obesity & body recomposition.

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.

It had four arms (groups): Semaglutide (Wegovy) + Group Therapy Program (experimental), Naltrexone/Bupropion (Contrave) + Group Therapy Program (experimental), Phentermine/Topiramate (Qsymia) + Group Therapy Program (experimental) and No Study Medication + Group Therapy Program (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

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.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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).

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: abdominal bariatric surgery: gastric bypass surgery (roux-en-y), adjustable gastric band (lap band), and gastric sleeve surgery (sleeve gastrectomy); 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™).

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-01-19 with completion listed for 2028-02-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Total body weight loss (in kilograms) from baseline to end point in patients with BD and obesity, Changes in metabolic parameters from baseline to end point in patients with BD, Changes in eating behavior from baseline to endpoint in patients with BD using validated questionnaires and Changes in mood symptoms from baseline to endpoint in patients with BD using validated questionnaires.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Semaglutide in 100 people with fat loss, obesity & body recomposition.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.