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| Name | Class |
|---|---|
| VIVUS LLC | INDUSTRY |
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This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. Individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.
While there is obvious focus on the obesity epidemic that affects approximately one-third of the U.S. population, one subgroup within the epidemic remains on the fringe of scientific study and effective treatment options. The super obese patient, in this instance defined as those with a BMI ≥ 50 kg/m2, presents a difficult treatment challenge in managing this level of obesity. While bariatric surgery, including Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch, have been shown to be effective in severe obesity (BMI ≥ 40 kg/m2), the risks involved with surgical intervention in the super obese patient are high.
Qsymia provides a potential opportunity to develop an effective treatment plan that would be an adjunct to surgical intervention in the super obese patient. Use of Qsymia in addition to a low-calorie dietary prescription pre-operatively would effectively decrease weight prior to surgical intervention, lowering surgical risk to some extent. Additionally, if continued post-operatively, Qsymia as an adjunct to the post-surgical dietary plan would potentially extend the weight loss horizon so that the probability of the typical weight loss plateau at 12-18 months is decreased.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phentermine/topiramate | Experimental | All subjects enrolled in the study will be placed on the study medication. |
|
| Historical Control | No Intervention | Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentermine/topiramate | Drug | Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) | Proportion of patients who do not meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia. The criteria that suggest RYGB is indicated are: 1) BMI of 40 or greater or 2) BMI of 35-39.9 with poorly controlled co-morbidities. | 24 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 24 months post-operatively |
| Body Mass Index | Resulting body mass index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamy D Ard, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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Retrospective chart review patients were not considered enrolled, but historical data was used as a comparison so it is included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phentermine/Topiramate | All subjects enrolled in the study will be placed on the study medication. Phentermine/topiramate: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery. |
| FG001 | Historical Control | Retrospective chart review of patients who had sleeve gastrectomy without phentermine/topiramate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phentermine/Topiramate | All subjects enrolled in the study will be placed on the study medication. Phentermine/topiramate: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery. |
| BG001 |
| 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 | Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) | Proportion of patients who do not meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia. The criteria that suggest RYGB is indicated are: 1) BMI of 40 or greater or 2) BMI of 35-39.9 with poorly controlled co-morbidities. | 2 participants had RYGB instead of Sleeve Gastrectomy | Posted | Count of Participants | Participants | 24 months post-operatively |
|
24 months
Adverse events ascertained at each clinical follow up. Retrospective chart review patients were not considered enrolled, so adverse event information was not collected for them.
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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 | All subjects enrolled in the study will be placed on the study medication. Phentermine/topiramate: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Panniculitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
This was an open-label, nonrandomized observational trial of only 2 years postoperative follow-up.
We also did not control for the amount of contact that patients received in the course of their treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamy Ard | Wake Forest School of Medicine | 336-716-9837 | jard@wakehealth.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 | Sep 28, 2018 | Aug 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C576188 | Qsymia |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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|
| low calorie diet | Other | The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions. |
|
| 24 months post-operatively |
| Percent Body Fat | Change in percent body fat | 24 months post-operatively |
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 24 months post-operatively |
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 12 months post-operatively |
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 6 months post-operatively |
| Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | Pre-operatively and 3 months post-operatively |
| Body Mass Index | Resulting body mass index | 12 months post-operatively |
| Body Mass Index | Resulting body mass index | 6 months post-operatively |
| Body Mass Index | Resulting body mass index | 3 months post-operatively |
| Percent Body Fat | Change in percent body fat | 12 months post-operatively |
| Percent Body Fat | Change in percent body fat | 6 months post-operatively |
| Percent Body Fat | Change in percent body fat | 3 months post-operatively |
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 12 months post-operatively |
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 6 months post-operatively |
| Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | 3 months post-operatively |
| Surgery Only |
Historical controls who had sleeve gastrectomy without phentermine/topiramate |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kilograms |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Surgery Only | Historical controls who had surgery only |
|
|
| Secondary | Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | 2 participants had RYGB instead of sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | Percentage of weight change | Pre-operatively and 24 months post-operatively |
|
|
|
| Secondary | Body Mass Index | Resulting body mass index | 2 participants had RYGB instead of Sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | kg/m^2 | 24 months post-operatively |
|
|
|
| Secondary | Percent Body Fat | Change in percent body fat | Measure not obtained | Posted | 24 months post-operatively |
|
|
| Secondary | Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | Outcome measure not obtained | Posted | 24 months post-operatively |
|
|
| Secondary | Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | 2 participants had RYGB instead of sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | Percent | Pre-operatively and 12 months post-operatively |
|
|
|
| Secondary | Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | 2 participants had RYGB instead of sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | Percent | Pre-operatively and 6 months post-operatively |
|
|
|
| Secondary | Percent Weight Change | Percent weight loss achieved before and after surgery while taking the medication, Qsymia. | 2 participants had RYGB instead of sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | Percent | Pre-operatively and 3 months post-operatively |
|
|
|
| Secondary | Body Mass Index | Resulting body mass index | 2 participants had RYGB instead of Sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | kg/m^2 | 12 months post-operatively |
|
|
|
| Secondary | Body Mass Index | Resulting body mass index | 2 participants had RYGB instead of Sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | kg/m^2 | 6 months post-operatively |
|
|
|
| Secondary | Body Mass Index | Resulting body mass index | 2 participants had RYGB instead of Sleeve gastrectomy | Posted | Mean | 95% Confidence Interval | kg/m^2 | 3 months post-operatively |
|
|
|
| Secondary | Percent Body Fat | Change in percent body fat | Measure not obtained | Posted | 12 months post-operatively |
|
|
| Secondary | Percent Body Fat | Change in percent body fat | Measure not obtained | Posted | 6 months post-operatively |
|
|
| Secondary | Percent Body Fat | Change in percent body fat | Measure not obtained | Posted | 3 months post-operatively |
|
|
| Secondary | Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | Outcome measure not obtained | Posted | 12 months post-operatively |
|
|
| Secondary | Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | Outcome measure not obtained | Posted | 6 months post-operatively |
|
|
| Secondary | Resting Metabolic Rate | Resting metabolic rate via indirect calorimetry | Outcome measure not obtained | Posted | 3 months post-operatively |
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| 3 |
| 25 |
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
| insomnia | Nervous system disorders | Systematic Assessment |
|
| irritability | Psychiatric disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |