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

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ClinicalTrials.gov Identifier: NCT04408586
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Andres J. Acosta, M.D., Ph.D., Mayo Clinic

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
Obesity Drug: Phentermine-Topiramate Extended Release Drug: Placebo Other: Online support system Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 3, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Primary Endpoint [ Time Frame: 3 months ]
    Total body weight loss (%) at 3 months


Secondary Outcome Measures :
  1. Secondary Endpoints [ Time Frame: 12 months ]
    Total body weight loss at 12 months (%).

  2. Secondary Endpoints [ Time Frame: 12 months ]
    Number of steps (average per week) at 12 months, steps

  3. Secondary Endpoints [ Time Frame: 12 months ]
    Calories tracked: calories per day (average per week) at 12 months, kcal.

  4. Secondary Endpoints [ Time Frame: 12 months ]
    Number of exercise sessions (average per week) at 12 months.

  5. Secondary Endpoints [ Time Frame: 12 months ]
    Hours/week using app/tracker (average per week) at 12 months, hours

  6. Secondary Endpoints [ Time Frame: 12 months ]
    Quality of life SF36 (at 12 months), 0-36 scale

  7. Secondary Endpoints [ Time Frame: 12 months ]
    Improvement in obesity-related comorbidities (yes/no)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408586


Contacts
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Contact: Linh Tran (507) 422-5891 RSTINDIVOBESITY@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Andres Acosta, MD, PhD Mayo Clinic
Additional Information:
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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    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Topiramate
Phentermine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action