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Qsymia as an Adjunct to Surgical Therapy in the Superobese

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02301416
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
VIVUS LLC
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Surgery Weight Loss Bariatric Surgery Procedures Drug: Phentermine/topiramate Other: low calorie diet Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Qsymia as an Adjunct to Surgical Therapy in the Superobese
Actual Study Start Date : December 2014
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301416


Locations
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United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
VIVUS LLC
Investigators
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Principal Investigator: Jamy D Ard, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] September 28, 2018

More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02301416    
Other Study ID Numbers: IRB00027047
First Posted: November 25, 2014    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Topiramate
Phentermine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
 Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action