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

Overview

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.

Full Title of Study: “Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 1, 2022

Interventions

  • Drug: Phentermine-Topiramate Extended Release
    • Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
  • Drug: Placebo
    • Placebo looks exactly like the study drug, but it contains no active ingredient
  • Other: Online support system
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Phentermine – Topiramate Extended Release group
  • Placebo Comparator: Placebo Group

Clinical Trial Outcome Measures

Primary Measures

  • Primary Endpoint
    • Time Frame: 3 months
    • Total body weight loss (%) at 3 months

Secondary Measures

  • Secondary Endpoints
    • Time Frame: 12 months
    • Total body weight loss at 12 months (%).
  • Secondary Endpoints
    • Time Frame: 12 months
    • Number of steps (average per week) at 12 months, steps
  • Secondary Endpoints
    • Time Frame: 12 months
    • Calories tracked: calories per day (average per week) at 12 months, kcal.
  • Secondary Endpoints
    • Time Frame: 12 months
    • Number of exercise sessions (average per week) at 12 months.
  • Secondary Endpoints
    • Time Frame: 12 months
    • Hours/week using app/tracker (average per week) at 12 months, hours
  • Secondary Endpoints
    • Time Frame: 12 months
    • Quality of life SF36 (at 12 months), 0-36 scale
  • Secondary Endpoints
    • Time Frame: 12 months
    • Improvement in obesity-related comorbidities (yes/no)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andres J. Acosta, M.D., Ph.D., Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Andres Acosta, MD, PhD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Linh Tran, (507) 422-5891, RSTINDIVOBESITY@mayo.edu

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