Qsymia as an Adjunct to Surgical Therapy in the Superobese

Phase 2

Completed

• Conditions: Metabolic Surgery; Bariatric Surgery Procedures; Obesity; Weight Loss
• Interventions: Drug: Phentermine/topiramate; Other: low calorie diet

• Registration Number: NCT02301416
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Study Start: 2014-12
• Primary Completion: 2018-06-27
• Study Completion: 2018-06-27
• Status Verified: 2018-11
• Results First Submitted: 2019-07-05
• Results First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Results First Posted: 2019-09-04
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• BMI ≥ 50 kg/m2
• Determined to be a good candidate for surgery based on medical and psychological exam.
• Willing to participate in a 3-6 month medically supervised weight loss plan prior to surgery.
• Planning to remain in the reasonable vicinity of the Wake Forest Baptist Health - Weight Management Center for the duration of the study.

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Exclusion Criteria

• History of prior weight loss surgery (removal/conversion from band to sleeve will not be excluded)
• Pregnant (women of childbearing potential will complete a pregnancy test (blood draw) to make sure they are not pregnant at the time that they initiate the medication). Ongoing monitoring of pregnancy status is the responsibility of the patient and they are instructed as such in the consent form.
• Ongoing use of weight loss medication
• Contraindications to use of Qsymia, including pregnancy, history of glaucoma, unstable cardiac disease (unstable angina, recent heart attack or stroke (in the past 6 months), uncontrolled arrhythmia), hyperthyroidism, taking monoamine oxidase inhibitors (MAOIs) or allergy to either topiramate or sympathomimetic amines like phentermine.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phentermine/topiramate	low calorie diet	All subjects enrolled in the study will be placed on the study medication.
Phentermine/topiramate	Phentermine/topiramate	All subjects enrolled in the study will be placed on the study medication.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent Weight Change	Pre-operatively and 3 months post-operatively	Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Body Mass Index	3 months post-operatively	Resulting body mass index
Percent Body Fat	3 months post-operatively	Change in percent body fat
Resting Metabolic Rate	3 months post-operatively	Resting metabolic rate via indirect calorimetry

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States