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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phentermine - Topiramate Extended Release group | Active Comparator |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentermine-Topiramate Extended Release | Drug | Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change | Change in weight calculated in kilograms. | baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change | Change in weight calculated in kilograms. | baseline, 12 months |
| Change in Step Count | The change in the number of steps per day |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andres Acosta, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41562388 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phentermine - Topiramate Extended Release Group | Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily 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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. |
| FG001 | Placebo Group | Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient 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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phentermine - Topiramate Extended Release Group | Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily 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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight Change | Change in weight calculated in kilograms. | Posted | Mean | 95% Confidence Interval | kilograms | baseline, 3 months |
|
Adverse Events were collected from baseline to end of study, approximately 12 months for each subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phentermine - Topiramate Extended Release Group | Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily 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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andres J. Acosta, M.D., Ph.D. | Mayo Clinic | 507-266-6931 | Acosta.Andres@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2021 | May 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C576188 | Qsymia |
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| Placebo | Drug | Placebo looks exactly like the study drug, but it contains no active ingredient |
|
| Online support system | Other | 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. |
|
| baseline,12 months |
| Change in Calories | The change in calories burned per day | baseline, 12 months |
| Exercise Sessions | The number of exercise sessions per week | 12 months |
| Tracker Usage | The amount of time in minutes the tracker was used per week | 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 | 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. | baseline, 12 months |
| BG001 | Placebo Group | Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient 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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient
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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
|
|
| Secondary | Body Weight Change | Change in weight calculated in kilograms. | Posted | Mean | 95% Confidence Interval | kilograms | baseline, 12 months |
|
|
|
| Secondary | Change in Step Count | The change in the number of steps per day | Posted | Mean | 95% Confidence Interval | steps per day | baseline,12 months |
|
|
|
| Secondary | Change in Calories | The change in calories burned per day | Posted | Mean | 95% Confidence Interval | kcal per day | baseline, 12 months |
|
|
|
| Secondary | Exercise Sessions | The number of exercise sessions per week | Posted | Mean | Standard Deviation | sessions per week | 12 months |
|
|
|
| Secondary | Tracker Usage | The amount of time in minutes the tracker was used per week | Posted | Mean | Standard Deviation | minutes/week | 12 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 12 months |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 11 |
| 42 |
| EG001 | Placebo Group | Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient 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 that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members. | 0 | 38 | 0 | 38 | 3 | 38 |
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |