Qsymia as an Adjunct to Surgical Therapy in the Superobese

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Metabolic Surgery; Bariatric Surgery Procedures
• Intervention / Treatment: Drug: Phentermine/topiramate; Other: low calorie diet

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phentermine/topiramate; All subjects enrolled in the study will be placed on the study medication.	Drug: 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.; Other Names: Qsymia; Other: low calorie diet; The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
No Intervention: Historical Control; Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: VIVUS LLC
• Investigators: Principal Investigator: Jamy D Ard, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 27, 2018
• Study Completion (Actual): June 27, 2018

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Topiramate; Phentermine
• Other Study ID Numbers: IRB00027047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No