A Study of Individualized Obesity Pharmacotherapy Based on Obesity Phenotypes

Overview

About this study

The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
  • Age: 18-75 years old.
  • Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrolment and before each radiation exposure.
  • Participant must have an abnormal phenotype based on testing done in visit 2.

Exclusion Criteria:

  • Abdominal bariatric surgery.
  • Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption; e.g., orlistat, within the last 6 months.
  • Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). 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.
  • Hypersensitivity to any of the study medications.
  • No contraindications to the FDA-approved medications: Phentermine-Topiramate Extended Release; Phentermine; ; Oral naltrexone extended-release/bupropion extended-release (NBSR; Contrave®, Mysimba™); and Liraglutide (Saxenda®).
  • Participants with >1 phenotype based on the following criteria:
    1. No match to any phenotype based upon 90th and 75th percentile criteria; or
    2. Matches 2 or more phenotype based upon 90th percentile criteria; or
    3. No match to phenotype based on 90th percentile criteria and 2 or more match to phenotype based upon 75th percentile criteria

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andres Acosta, M.D., Ph.D.

Closed for enrollment

Contact information:

Linh Tran B.S.W.

(507) 422-5891

rstindivobesity@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20362899

Mayo Clinic Footer