ObesityPhase 4NCT04408586

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

A Phase 4 study testing Phentermine-Topiramate Extended Release and Online support system in people with Obesity, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Phentermine-Topiramate Extended Release and Online support system
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 3 Jun 2020to 11 Oct 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Conditions: Obesity
Being tested: Phentermine-Topiramate Extended Release, Placebo, Online support system
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phentermine-Topiramate Extended ReleaseDrug
Also called Qsymia
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
PlaceboDrug
Placebo looks exactly like the study drug, but it contains no active ingredient
Online support systemOther
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.

Study groups in NCT04408586
Study group	Role	What they receive
Phentermine - Topiramate Extended Release group	Active comparator	Not described Receives: Drug: Phentermine-Topiramate Extended Release; Other: Online support system
Placebo Group	Placebo comparator	Not described Receives: Drug: Placebo; Other: Online support system

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Weight Change
Change in weight calculated in kilograms.
Measured: baseline, 3 months

Secondary outcomes (7)

Body Weight Change
Change in weight calculated in kilograms.
Measured: baseline, 12 months
Change in Step Count
The change in the number of steps per day
Measured: baseline,12 months
Change in Calories
The change in calories burned per day
Measured: baseline, 12 months
Exercise Sessions
The number of exercise sessions per week
Measured: 12 months
Tracker Usage
The amount of time in minutes the tracker was used per week
Measured: 12 months
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
Measured: baseline, 12 months
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.
Measured: baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202011 Oct 2022

First posted29 May 2020
Study start3 Jun 2020
Primary completion13 Jun 2022
Study completion11 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04408586
Sponsor's protocol ID: 19-011697
Status last verified: Jun 2023
First submitted: 21 May 2020
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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 Mar;34(3):524-536. doi: 10.1002/oby.70108. Epub 2026 Jan 21.
PubMed 41562388

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.
ClinicalTrials.gov ID: NCT04408586
Acronym / sponsor ID: 19-011697
Conditions: Obesity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 3 Jun 2020 (actual)
Primary completion: 13 Jun 2022 (actual)
Study completion: 11 Oct 2022 (actual)
First posted: 29 May 2020 (actual)
Results: Posted 22 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Phentermine - Topiramate Extended Release group	Active comparator	Drug: Phentermine-Topiramate Extended Release, Other: Online support system
Placebo Group	Placebo comparator	Drug: Placebo, Other: Online support system

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Phentermine-Topiramate Extended ReleaseAlso: QsymiaDosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily	Drug	Phentermine - Topiramate Extended Release group
PlaceboPlacebo looks exactly like the study drug, but it contains no active ingredient	Drug	Placebo Group
Online support systemVitalCare (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.	Other	Phentermine - Topiramate Extended Release group, Placebo Group

Primary outcome

Body Weight Change
Time frame: baseline, 3 months
Change in weight calculated in kilograms.

7 secondary outcomes

Body Weight Change
Time frame: baseline, 12 months
Change in Step Count
Time frame: baseline,12 months
Change in Calories
Time frame: baseline, 12 months
Exercise Sessions
Time frame: 12 months
Tracker Usage
Time frame: 12 months
Change in SF-12 Physical Score (Health-related Quality Quality of Life)
Time frame: baseline, 12 months
Change in SF-12 Mental Score (Health-related Quality Quality of Life)
Time frame: baseline, 12 months

Results and safety

Results posted to the registry on 22 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phentermine - Topiramate Extended Release Group	42	42
Placebo Group	38	38

Primary outcome: Body Weight Change

Time frame: baseline, 3 months. Mean (95% Confidence Interval). Unit: kilograms

Measure	Phentermine - Topiramate Extended Release Group n = 42	Placebo Group n = 38
Value	-10.80 (-13.72 to -7.92)	-4.04 (-7.05 to -1.04)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from baseline to end of study, approximately 12 months for each subject. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phentermine - Topiramate Extended Release Group	0 of 42 (0%)	11 of 42 (26.2%)	0 of 42
Placebo Group	0 of 38 (0%)	3 of 38 (7.9%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41562388Campos 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 Mar;34(3):524-536. doi: 10.1002/oby.70108. Epub 2026 Jan 21.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andres Acosta, MD, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Phentermine-Topiramate Extended Release and Online support system in people with Obesity, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight Change (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04408586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.