Qsymia as an Adjunct to Surgical Therapy in the Superobese

• ClinicalTrials.gov Identifier: NCT02301416
• Recruitment Status: Completed
• First Posted: November 25, 2014
• Results First Posted: September 4, 2019
• Last Update Posted: September 4, 2019
• Sponsor: Wake Forest University Health Sciences
• Collaborator: VIVUS, Inc.
• Information provided by (Responsible Party): Wake Forest University Health Sciences

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Obesity; Metabolic Surgery; Weight Loss; Bariatric Surgery Procedures
• Interventions: Drug: Phentermine/topiramate; Other: low calorie diet
• Enrollment: 25

Participant Flow

Recruitment Details	Retrospective chart review patients were not considered enrolled, but historical data was used as a comparison so it is included.
Pre-assignment Details

Arm/Group Title	Phentermine/Topiramate	Historical Control
Arm/Group Description	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.	Retrospective chart review of patients who had sleeve gastrectomy without phentermine/topiramate
Period Title: Overall Study
Started	25	40
Completed	15	40
Not Completed	10	0

Baseline Characteristics

Arm/Group Title		Phentermine/Topiramate	Surgery Only	Total
Arm/Group Description		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.	Historical controls who had sleeve gastrectomy without phentermine/topiramate	Total of all reporting groups
Overall Number of Baseline Participants		15	40	55
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	40 participants	55 participants
		43.4 (7.3)	45 (10.8)	44.6 (10)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	40 participants	55 participants
	Female	12 80.0%	33 82.5%	45 81.8%
	Male	3 20.0%	7 17.5%	10 18.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	40 participants	55 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	15 100.0%	40 100.0%	55 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	40 participants	55 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	03 20.0%	9 22.5%	12 21.8%
	White	12 80.0%	31 77.5%	43 78.2%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	15 participants	40 participants	55 participants
		15	40	55
Body weight; Mean (Standard Deviation); Unit of measure: Kilograms
	Number Analyzed	15 participants	40 participants	55 participants
		178.9 (31.1)	159.5 (21)	164.8 (25.4)
Body mass index; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	15 participants	40 participants	55 participants
		61.2 (7.1)	57 (5.6)	58.1 (6.3)

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)
Description	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.
Time Frame	24 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of Sleeve Gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Measure Type: Count of Participants; Unit of Measure: Participants
	8 61.5%	19 47.5%

2. Secondary Outcome

Title	Percent Weight Change
Description	Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame	Pre-operatively and 24 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: Percentage of weight change
	-38.16; (-45.39 to -30.94)	-27; (-31.02 to -22.99)

3. Secondary Outcome

Title	Body Mass Index
Description	Resulting body mass index
Time Frame	24 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of Sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: kg/m^2
	33.79; (29.47 to 38.12)	41.96; (39.47 to 44.45)

4. Secondary Outcome

Title	Percent Body Fat
Description	Change in percent body fat
Time Frame	24 months post-operatively

Outcome Measure Data

Analysis Population Description

Measure not obtained

Arm/Group Title	Phentermine/Topiramate	Historical Control
Arm/Group Description:	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.	Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Resting Metabolic Rate
Description	Resting metabolic rate via indirect calorimetry
Time Frame	24 months post-operatively

Outcome Measure Data

Analysis Population Description

Outcome measure not obtained

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Percent Weight Change
Description	Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame	Pre-operatively and 12 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: Percent
	-39.34; (-45.36 to -33.32)	-31.43; (-34.86 to -28.01)

7. Secondary Outcome

Title	Percent Weight Change
Description	Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame	Pre-operatively and 6 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: Percent
	-32.79; (-37.56 to -28.02)	-27.25; (-29.97 to -24.53)

8. Secondary Outcome

Title	Percent Weight Change
Description	Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Time Frame	Pre-operatively and 3 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: Percent
	-25.24; (-29.63 to -20.84)	-21.46; (-23.96 to -18.97)

9. Secondary Outcome

Title	Body Mass Index
Description	Resulting body mass index
Time Frame	12 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of Sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: kg/m^2
	33.46; (29.94 to 36.98)	39.53; (37.43 to 41.63)

10. Secondary Outcome

Title	Body Mass Index
Description	Resulting body mass index
Time Frame	6 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of Sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: kg/m^2
	37.61; (34.83 to 40.38)	41.93; (40.23 to 43.63)

11. Secondary Outcome

Title	Body Mass Index
Description	Resulting body mass index
Time Frame	3 months post-operatively

Outcome Measure Data

Analysis Population Description

2 participants had RYGB instead of Sleeve gastrectomy

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	13	40
Mean (95% Confidence Interval); Unit of Measure: kg/m^2
	42.31; (39.78 to 44.84)	45.28; (43.71 to 46.84)

12. Secondary Outcome

Title	Percent Body Fat
Description	Change in percent body fat
Time Frame	12 months post-operatively

Outcome Measure Data

Analysis Population Description

Measure not obtained

Arm/Group Title	Phentermine/Topiramate	Historical Control
Arm/Group Description:	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.	Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

13. Secondary Outcome

Title	Percent Body Fat
Description	Change in percent body fat
Time Frame	6 months post-operatively

Outcome Measure Data

Analysis Population Description

Measure not obtained

Arm/Group Title	Phentermine/Topiramate	Historical Control
Arm/Group Description:	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.	Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

14. Secondary Outcome

Title	Percent Body Fat
Description	Change in percent body fat
Time Frame	3 months post-operatively

Outcome Measure Data

Analysis Population Description

Measure not obtained

Arm/Group Title	Phentermine/Topiramate	Historical Control
Arm/Group Description:	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.	Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

15. Secondary Outcome

Title	Resting Metabolic Rate
Description	Resting metabolic rate via indirect calorimetry
Time Frame	12 months post-operatively

Outcome Measure Data

Analysis Population Description

Outcome measure not obtained

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

16. Secondary Outcome

Title	Resting Metabolic Rate
Description	Resting metabolic rate via indirect calorimetry
Time Frame	6 months post-operatively

Outcome Measure Data

Analysis Population Description

Outcome measure not obtained

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

17. Secondary Outcome

Title	Resting Metabolic Rate
Description	Resting metabolic rate via indirect calorimetry
Time Frame	3 months post-operatively

Outcome Measure Data

Analysis Population Description

Outcome measure not obtained

Arm/Group Title	Phentermine/Topiramate	Surgery Only
Arm/Group Description:	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.	Historical controls who had surgery only
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	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.
Arm/Group Title	Phentermine/Topiramate
Arm/Group Description	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.
All-Cause Mortality
	Phentermine/Topiramate
	Affected / at Risk (%)
Total	0/25 (0.00%)
Serious Adverse Events
	Phentermine/Topiramate
	Affected / at Risk (%)	# Events
Total	2/25 (8.00%)
Infections and infestations
Panniculitis †	1/25 (4.00%)	1
Psychiatric disorders
Suicidal ideation *	1/25 (4.00%)	1
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Phentermine/Topiramate
	Affected / at Risk (%)	# Events
Total	3/25 (12.00%)
Nervous system disorders
insomnia †	1/25 (4.00%)	1
Psychiatric disorders
irritability †	1/25 (4.00%)	1
Respiratory, thoracic and mediastinal disorders
Hypoxia †	1/25 (4.00%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Jamy Ard
• Organization: Wake Forest School of Medicine
• Phone: 336-716-9837
• EMail: jard@wakehealth.edu

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02301416
• Other Study ID Numbers: IRB00027047
• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Results First Submitted: July 5, 2019
• Results First Posted: September 4, 2019
• Last Update Posted: September 4, 2019