This trial is active, not recruiting.

Conditions obesity, metabolic surgery, weight loss, bariatric surgery procedures
Treatment phentermine/topiramate
Sponsor Wake Forest School of Medicine
Collaborator VIVUS, Inc.
Start date December 2014
End date December 2017
Trial size 21 participants
Trial identifier NCT02301416, IRB00027047


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
All subjects enrolled in the study will be placed on the study medication.
phentermine/topiramate Qsymia
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.

Primary Outcomes

Roux en Y Gastric Bypass
time frame: 24 months post-operatively

Secondary Outcomes

Percent weight loss
time frame: Pre-operatively and 24 months post-operatively
Percent body fat
time frame: Pre-operatively and 24 months post-operatively
Resting Metabolic Rate
time frame: pre-operatively and 24 months post-operatively

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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 MAOIs (monoamine oxidase inhibitors) or allergy to either topiramate or sympathomimetic amines like phentermine.

Additional Information

Official title Qsymia as an Adjunct to Surgical Therapy in the Superobese
Principal investigator Jamy D Ard, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.