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

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04408586
Collaborator
(none)
80
1
2
27.3
2.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Phentermine-Topiramate Extended Release
  • Drug: Placebo
  • Other: Online support system
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.
Actual Study Start Date :
Jun 3, 2020
Actual Primary Completion Date :
Jun 13, 2022
Anticipated Study Completion Date :
Sep 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Phentermine - Topiramate Extended Release group

Drug: Phentermine-Topiramate Extended Release
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
Other Names:
  • Qsymia
  • 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.

    Placebo Comparator: Placebo Group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Primary Endpoint [3 months]

      Total body weight loss (%) at 3 months

    Secondary Outcome Measures

    1. Secondary Endpoints [12 months]

      Total body weight loss at 12 months (%).

    2. Secondary Endpoints [12 months]

      Number of steps (average per week) at 12 months, steps

    3. Secondary Endpoints [12 months]

      Calories tracked: calories per day (average per week) at 12 months, kcal.

    4. Secondary Endpoints [12 months]

      Number of exercise sessions (average per week) at 12 months.

    5. Secondary Endpoints [12 months]

      Hours/week using app/tracker (average per week) at 12 months, hours

    6. Secondary Endpoints [12 months]

      Quality of life SF36 (at 12 months), 0-36 scale

    7. Secondary Endpoints [12 months]

      Improvement in obesity-related comorbidities (yes/no)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Andres Acosta, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Andres J. Acosta, M.D., Ph.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04408586
    Other Study ID Numbers:
    • 19-011697
    First Posted:
    May 29, 2020
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022