Qsymia as an Adjunct to Surgical Therapy in the Superobese

NCT02301416 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00027047
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Surgery; Weight Loss; Bariatric Surgery Procedures

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 months post-operatively

Secondary Outcomes (16)

• Percent Weight Change

  Pre-operatively and 24 months post-operatively

• Body Mass Index

  24 months post-operatively

• Percent Body Fat

  24 months post-operatively

• Resting Metabolic Rate

  24 months post-operatively

• Percent Weight Change

  Pre-operatively and 12 months post-operatively

Study Arms (2)

Phentermine/topiramate

EXPERIMENTAL

All subjects enrolled in the study will be placed on the study medication.

Drug: Phentermine/topiramate; Other: low calorie diet

Historical Control

NO INTERVENTION

Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment

Interventions

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.

Also known as: Qsymia

Phentermine/topiramate

low calorie diet OTHER

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

Phentermine/topiramate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• VIVUS LLC: collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Qsymia; Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

This was an open-label, nonrandomized observational trial of only 2 years postoperative follow-up. We also did not control for the amount of contact that patients received in the course of their treatment.

Results Point of Contact

• Title: Jamy Ard
• Organization: Wake Forest School of Medicine

jard@wakehealth.edu

336-716-9837

Study Officials

• Jamy D Ard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)