Qsymia as an Adjunct to Surgical Therapy in the Superobese

• Status: Completed
• Trial end date: 2018-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: VIVUS, Inc.
• Treatments: Phentermine; Topiramate

Criteria

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.