Phase 2
N=65
Qsymia as an Adjunct to Surgical Therapy in the Superobese
Obesity · Metabolic Surgery · Weight Loss · Bariatric Surgery Procedures
Bottom Line
View on ClinicalTrials.gov: NCT02301416 ↗Enrolled (actual)
65
Serious AEs
8.0%
Results posted
Sep 2019
Primary outcome: Primary: Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) — 8; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Phentermine/topiramate (Drug); low calorie diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB) |
8; 19 | — |
| SECONDARY Percent Weight Change |
-25.24; -21.46 | — |
| SECONDARY Body Mass Index |
42.31; 45.28 | — |
| SECONDARY Percent Body Fat |
— | — |
| SECONDARY Resting Metabolic Rate |
— | — |
| SECONDARY Percent Weight Change |
-25.24; -21.46 | — |
| SECONDARY Percent Weight Change |
-25.24; -21.46 | — |
| SECONDARY Percent Weight Change |
-25.24; -21.46 | — |
| SECONDARY Body Mass Index |
42.31; 45.28 | — |
| SECONDARY Body Mass Index |
42.31; 45.28 | — |
| SECONDARY Body Mass Index |
42.31; 45.28 | — |
| SECONDARY Percent Body Fat |
— | — |
| SECONDARY Percent Body Fat |
— | — |
| SECONDARY Percent Body Fat |
— | — |
| SECONDARY Resting Metabolic Rate |
— | — |
| SECONDARY Resting Metabolic Rate |
— | — |
| SECONDARY Resting Metabolic Rate |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02301416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.