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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phentermine-Topiramate Extended Release
Placebo
Online support system
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Phentermine - Topiramate Extended Release group

Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

Body Weight Change
Change in weight calculated in kilograms.

Secondary Outcome Measures

Body Weight Change
Change in weight calculated in kilograms.
Change in Step Count
The change in the number of steps per day
Change in Calories
The change in calories burned per day
Exercise Sessions
The number of exercise sessions per week
Tracker Usage
The amount of time in minutes the tracker was used per week
Change in SF-12 Physical Score (Health-related Quality Quality of Life)
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
Change in SF-12 Mental Score (Health-related Quality Quality of Life)
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.

Full Information

First Posted
May 21, 2020
Last Updated
June 15, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04408586
Brief Title
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
Official Title
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phentermine - Topiramate Extended Release group
Arm Type
Active Comparator
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Phentermine-Topiramate Extended Release
Other Intervention Name(s)
Qsymia
Intervention Description
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo looks exactly like the study drug, but it contains no active ingredient
Intervention Type
Other
Intervention Name(s)
Online support system
Intervention Description
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 Outcome Measure Information:
Title
Body Weight Change
Description
Change in weight calculated in kilograms.
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Body Weight Change
Description
Change in weight calculated in kilograms.
Time Frame
baseline, 12 months
Title
Change in Step Count
Description
The change in the number of steps per day
Time Frame
baseline,12 months
Title
Change in Calories
Description
The change in calories burned per day
Time Frame
baseline, 12 months
Title
Exercise Sessions
Description
The number of exercise sessions per week
Time Frame
12 months
Title
Tracker Usage
Description
The amount of time in minutes the tracker was used per week
Time Frame
12 months
Title
Change in SF-12 Physical Score (Health-related Quality Quality of Life)
Description
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
Time Frame
baseline, 12 months
Title
Change in SF-12 Mental Score (Health-related Quality Quality of Life)
Description
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.
Time Frame
baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Acosta, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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