A Study of a Novel Precision Medicine Approach for Obesity
NCT ID: NCT06814938
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
135 participants
INTERVENTIONAL
2025-02-21
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Semaglutide Group
Subjects will take semaglutide weekly for 24 weeks
Semaglutide
2.4 mg subcutaneous weekly
Placebo Group
Subjects will take placebo weekly for 24 weeks.
Placebo
Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly
Interventions
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Semaglutide
2.4 mg subcutaneous weekly
Placebo
Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of bariatric surgery including lap band and bariatric endoscopy
* Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month.
* Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
* Any contraindication to FDA-approved GLP1R agonists
* A person who is pregnant or wanting to become pregnant
* Once the positive or negative cohort is filled at 2:1 ratio, some patients will be screen failed if their gene cohort is full.
* A family member who is enrolled in this study.
* Principal Investigator Discretion
18 Years
65 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Phenomix Sciences
UNKNOWN
Mayo Clinic
OTHER
Responsible Party
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Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Andres Acosta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Other Identifiers
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23-006754
Identifier Type: -
Identifier Source: org_study_id
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