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NCT07213466 · ClinicalTrials.gov registry record · Phase 4

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

A Phase 4 study of Obesity and Weight Loss, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 4
Development phase
100
Enrollment target
1
Study location

NCT07213466 is a Phase 4 study of Obesity and Weight Loss that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 100 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07213466, a Phase 4 study of Obesity and Weight Loss, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 4
Development phase
100 participants
Enrollment target
1
Study location

Study 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. 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

Conditions Studied

Obesity Weight Loss Bipolar I Disorder Schizo Affective Disorder Bipolar II Disorder GLP-1

Interventions

  • DRUG semaglutide
  • BEHAVIORAL Group Therapy Program
  • DRUG Phentermine-Topiramate
  • DRUG naltrexone and bupropion (combination)

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2026-01-19
Est. Completion 2029-02-01
Phase Phase 4

Sponsor

Mayo Clinic

2,844 total trials

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What the Registry Record Tells You About NCT07213466

The ClinicalTrials.gov registry entry for NCT07213466 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which semaglutide is the first listed.

NCT07213466 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT07213466 about?

NCT07213466 is a clinical study titled "Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder". 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 ans...

What is the current status of trial NCT07213466?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2026-01-19. Estimated completion is 2029-02-01.

What conditions does trial NCT07213466 study?

This clinical trial studies the following conditions: Obesity, Weight Loss, Bipolar I Disorder, Schizo Affective Disorder, Bipolar II Disorder.

What interventions are being tested in trial NCT07213466?

The interventions under investigation include: semaglutide (DRUG), Group Therapy Program (BEHAVIORAL), Phentermine-Topiramate (DRUG), naltrexone and bupropion (combination) (DRUG).

Who is sponsoring clinical trial NCT07213466?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07213466 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.