Individualized Obesity Pharmacotherapy

June 27, 2023 updated by: Andres J. Acosta, M.D., Ph.D., Mayo Clinic

Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity. All participants will receive a standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and they could contact their physician to continue a FDA-approved medication as part of clinical care. Study team will prospectively follow the patients' weight, waist circumference and use of obesity medications every 3 months for 1 year.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Adults with obesity (BMI >30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
  • Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.

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 all FDA-approved medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Drug: Phentermine-Topiramate
Extended Release at dose of 7.5/46 mg oral daily
Other Names:
  • Qsymia
Drug: Liraglutide
dose of 3 mg subcutaneous daily
Other Names:
  • Saxenda
Drug: Naltrexone/bupropion
Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Other Names:
  • Contrave
Active Comparator: Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Drug: Phentermine-Topiramate
Extended Release at dose of 7.5/46 mg oral daily
Other Names:
  • Qsymia
Drug: Liraglutide
dose of 3 mg subcutaneous daily
Other Names:
  • Saxenda
Drug: Naltrexone/bupropion
Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Other Names:
  • Contrave
Drug: Phentermine
15-37.5 mg oral daily
Other Names:
  • Lomaira
  • Adipex-P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Body Weight
Time Frame: baseline to 12 weeks
Percent change in body weight
baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders
Time Frame: baseline to 12 weeks
Percentage of participants who loss 5% or more of total body weight
baseline to 12 weeks
Percentage of Responders
Time Frame: baseline to 12 weeks
Percentage of participants with at least 10% total body weight loss
baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Andres J Acosta, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2017

Primary Completion (Actual)

May 26, 2022

Study Completion (Actual)

May 26, 2022

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 15, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-003449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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