Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 obesity
Started Jun 2020
Typical duration for phase_4 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
June 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2022
CompletedResults Posted
Study results publicly available
June 22, 2023
CompletedJune 22, 2023
June 1, 2023
2 years
May 21, 2020
May 23, 2023
June 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Body Weight Change
Change in weight calculated in kilograms.
baseline, 3 months
Secondary Outcomes (7)
Body Weight Change
baseline, 12 months
Change in Step Count
baseline,12 months
Change in Calories
baseline, 12 months
Exercise Sessions
12 months
Tracker Usage
12 months
- +2 more secondary outcomes
Study Arms (2)
Phentermine - Topiramate Extended Release group
ACTIVE COMPARATORPlacebo Group
PLACEBO COMPARATORInterventions
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
Placebo looks exactly like the study drug, but it contains no active ingredient
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
Campos A, Ghusn W, Cifuentes L, Sacoto D, Fansa S, Anazco D, Ricardo-Silgado ML, Hashem A, Schaefer M, Harmsen WS, Gunn HJ, Peterson C, Larsen D, Varghese ST, Hurtado MD, Acosta A. Addition of Phentermine-Topiramate to a Digitally Enhanced Lifestyle Intervention: A Double-Blind Randomized Clinical Trial. Obesity (Silver Spring). 2026 Jan 21. doi: 10.1002/oby.70108. Online ahead of print.
PMID: 41562388DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andres J. Acosta, M.D., Ph.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Andres Acosta, MD, PhD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 21, 2020
First Posted
May 29, 2020
Study Start
June 3, 2020
Primary Completion
June 13, 2022
Study Completion
October 11, 2022
Last Updated
June 22, 2023
Results First Posted
June 22, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share