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Completed

NCT Number: NCT04408586

Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker

Researchers are assessing the effects of weight loss medication vs a placebo among participants provided with a wearable activity tracker, digital wellness devices and lifestyle recommendations.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for 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.
  • Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
  • Women of childbearing potential must agree to use a method of effective contraception during study participation.
  • Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
  • Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures

Exclusion criteria

  • History of Abdominal bariatric surgery
  • Weight is greater than 450 lbs (204 kg)
  • Recent use (within the last three months) of any antiobesity medication
  • Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months)
  • 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 or contraindication to the study medication.
  • Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
  • Principal Investigator discretion

Treatment and study plan

Phentermine-Topiramate Extended Release

Drug

Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily

Other names: Qsymia

Placebo

Drug

Placebo looks exactly like the study drug, but it contains no active ingredient

Online support system

Other

VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.

Primary outcomes

  1. Body Weight Change

    Time frame: baseline, 3 months

    Change in weight calculated in kilograms.

Secondary outcomes

  1. Body Weight Change

    Time frame: baseline, 12 months

    Change in weight calculated in kilograms.

  2. Change in Step Count

    Time frame: baseline,12 months

    The change in the number of steps per day

  3. Change in Calories

    Time frame: baseline, 12 months

    The change in calories burned per day

  4. Exercise Sessions

    Time frame: 12 months

    The number of exercise sessions per week

  5. Tracker Usage

    Time frame: 12 months

    The amount of time in minutes the tracker was used per week

  6. Change in SF-12 Physical Score (Health-related Quality Quality of Life)

    Time frame: baseline, 12 months

    Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome

  7. Change in SF-12 Mental Score (Health-related Quality Quality of Life)

    Time frame: baseline, 12 months

    Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 29, 2020
Registry last updated
Jun 22, 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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