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Completed

NCT Number: NCT02301416

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phentermine/topiramate

Drug

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

low calorie diet

Other

The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.

Primary outcomes

  1. Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)

    Time frame: 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 outcomes

  1. Percent Weight Change

    Time frame: Pre-operatively and 24 months post-operatively

    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

  2. Body Mass Index

    Time frame: 24 months post-operatively

    Resulting body mass index

  3. Percent Body Fat

    Time frame: 24 months post-operatively

    Change in percent body fat

  4. Resting Metabolic Rate

    Time frame: 24 months post-operatively

    Resting metabolic rate via indirect calorimetry

  5. Percent Weight Change

    Time frame: Pre-operatively and 12 months post-operatively

    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

  6. Percent Weight Change

    Time frame: Pre-operatively and 6 months post-operatively

    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

  7. Percent Weight Change

    Time frame: Pre-operatively and 3 months post-operatively

    Percent weight loss achieved before and after surgery while taking the medication, Qsymia.

  8. Body Mass Index

    Time frame: 12 months post-operatively

    Resulting body mass index

  9. Body Mass Index

    Time frame: 6 months post-operatively

    Resulting body mass index

  10. Body Mass Index

    Time frame: 3 months post-operatively

    Resulting body mass index

  11. Percent Body Fat

    Time frame: 12 months post-operatively

    Change in percent body fat

  12. Percent Body Fat

    Time frame: 6 months post-operatively

    Change in percent body fat

  13. Percent Body Fat

    Time frame: 3 months post-operatively

    Change in percent body fat

  14. Resting Metabolic Rate

    Time frame: 12 months post-operatively

    Resting metabolic rate via indirect calorimetry

  15. Resting Metabolic Rate

    Time frame: 6 months post-operatively

    Resting metabolic rate via indirect calorimetry

  16. Resting Metabolic Rate

    Time frame: 3 months post-operatively

    Resting metabolic rate via indirect calorimetry

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • VIVUS LLC

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2014
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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