Trial Outcomes & Findings for Qsymia as an Adjunct to Surgical Therapy in the Superobese (NCT NCT02301416)

NCT ID: NCT02301416

Last Updated: 2019-09-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 24 months post-operatively
• Results posted on: 2019-09-04

Participant Flow

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

Participant milestones

Measure	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.	Historical Control Retrospective chart review of patients who had sleeve gastrectomy without phentermine/topiramate
Overall Study STARTED	25	40
Overall Study COMPLETED	15	40
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Qsymia as an Adjunct to Surgical Therapy in the Superobese

Baseline characteristics by cohort

Measure	Phentermine/Topiramate n=15 Participants 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.	Surgery Only n=40 Participants Historical controls who had sleeve gastrectomy without phentermine/topiramate	Total n=55 Participants Total of all reporting groups
Age, Continuous	43.4 years STANDARD_DEVIATION 7.3 • n=5 Participants	45 years STANDARD_DEVIATION 10.8 • n=7 Participants	44.6 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	33 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	40 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	03 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	31 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	40 participants n=7 Participants	55 participants n=5 Participants
Body weight	178.9 kilograms STANDARD_DEVIATION 31.1 • n=5 Participants	159.5 kilograms STANDARD_DEVIATION 21 • n=7 Participants	164.8 kilograms STANDARD_DEVIATION 25.4 • n=5 Participants
Body mass index	61.2 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants	57 kg/m^2 STANDARD_DEVIATION 5.6 • n=7 Participants	58.1 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months post-operatively

Population: 2 participants had RYGB instead of Sleeve Gastrectomy

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.

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)	8 Participants	19 Participants

SECONDARY outcome

Timeframe: Pre-operatively and 24 months post-operatively

Population: 2 participants had RYGB instead of sleeve gastrectomy

Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Percent Weight Change	-38.16 Percentage of weight change Interval -45.39 to -30.94	-27 Percentage of weight change Interval -31.02 to -22.99

SECONDARY outcome

Timeframe: 24 months post-operatively

Population: 2 participants had RYGB instead of Sleeve gastrectomy

Resulting body mass index

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Body Mass Index	33.79 kg/m^2 Interval 29.47 to 38.12	41.96 kg/m^2 Interval 39.47 to 44.45

SECONDARY outcome

Timeframe: 24 months post-operatively

Population: Measure not obtained

Change in percent body fat

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months post-operatively

Population: Outcome measure not obtained

Resting metabolic rate via indirect calorimetry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-operatively and 12 months post-operatively

Population: 2 participants had RYGB instead of sleeve gastrectomy

Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Percent Weight Change	-39.34 Percent Interval -45.36 to -33.32	-31.43 Percent Interval -34.86 to -28.01

SECONDARY outcome

Timeframe: Pre-operatively and 6 months post-operatively

Population: 2 participants had RYGB instead of sleeve gastrectomy

Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Percent Weight Change	-32.79 Percent Interval -37.56 to -28.02	-27.25 Percent Interval -29.97 to -24.53

SECONDARY outcome

Timeframe: Pre-operatively and 3 months post-operatively

Population: 2 participants had RYGB instead of sleeve gastrectomy

Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Percent Weight Change	-25.24 Percent Interval -29.63 to -20.84	-21.46 Percent Interval -23.96 to -18.97

SECONDARY outcome

Timeframe: 12 months post-operatively

Population: 2 participants had RYGB instead of Sleeve gastrectomy

Resulting body mass index

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Body Mass Index	33.46 kg/m^2 Interval 29.94 to 36.98	39.53 kg/m^2 Interval 37.43 to 41.63

SECONDARY outcome

Timeframe: 6 months post-operatively

Population: 2 participants had RYGB instead of Sleeve gastrectomy

Resulting body mass index

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Body Mass Index	37.61 kg/m^2 Interval 34.83 to 40.38	41.93 kg/m^2 Interval 40.23 to 43.63

SECONDARY outcome

Timeframe: 3 months post-operatively

Population: 2 participants had RYGB instead of Sleeve gastrectomy

Resulting body mass index

Outcome measures

Measure	Phentermine/Topiramate n=13 Participants 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.	Surgery Only n=40 Participants Historical controls who had surgery only
Body Mass Index	42.31 kg/m^2 Interval 39.78 to 44.84	45.28 kg/m^2 Interval 43.71 to 46.84

SECONDARY outcome

Timeframe: 12 months post-operatively

Population: Measure not obtained

Change in percent body fat

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post-operatively

Population: Measure not obtained

Change in percent body fat

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months post-operatively

Population: Measure not obtained

Change in percent body fat

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months post-operatively

Population: Outcome measure not obtained

Resting metabolic rate via indirect calorimetry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post-operatively

Population: Outcome measure not obtained

Resting metabolic rate via indirect calorimetry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months post-operatively

Population: Outcome measure not obtained

Resting metabolic rate via indirect calorimetry

Outcome measures

Outcome data not reported

Adverse Events

Phentermine/Topiramate

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phentermine/Topiramate n=25 participants at risk 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.
Infections and infestations Panniculitis	4.0% 1/25 • Number of events 1 • 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.
Psychiatric disorders Suicidal ideation	4.0% 1/25 • Number of events 1 • 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.

Other adverse events

Measure	Phentermine/Topiramate n=25 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.0% 1/25 • Number of events 1 • 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.
Nervous system disorders insomnia	4.0% 1/25 • Number of events 1 • 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.
Psychiatric disorders irritability	4.0% 1/25 • Number of events 1 • 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.

Additional Information

Jamy Ard

Wake Forest School of Medicine

Phone: 336-716-9837

Email: jard@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place