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OpenTrials
Completed

NCT Number: NCT03374956

Individualized Obesity Pharmacotherapy

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phentermine-Topiramate

Drug

Extended Release at dose of 7.5/46 mg oral daily

Other names: Qsymia

liraglutide

Drug

dose of 3 mg subcutaneous daily

Other names: Saxenda

Naltrexone/Bupropion

Drug

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

Phentermine

Drug

15-37.5 mg oral daily

Other names: Adipex-P, Lomaira

Primary outcomes

  1. Change in Total Body Weight

    Time frame: baseline to 12 weeks

    Percent change in body weight

Secondary outcomes

  1. Percentage of Responders

    Time frame: baseline to 12 weeks

    Percentage of participants who loss 5% or more of total body weight

  2. Percentage of Responders

    Time frame: baseline to 12 weeks

    Percentage of participants with at least 10% total body weight loss

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2017
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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