ObesityPhase 2NCT02301416
Qsymia as an Adjunct to Surgical Therapy in the Superobese
A Phase 2 study testing Phentermine/topiramate and low calorie diet in people with Obesity and Metabolic Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Metabolic Surgery, Weight Loss
- What is being tested?
- Phentermine/topiramate and low calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 27 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Obesity, Metabolic Surgery, Weight Loss, Bariatric Surgery Procedures
- Being tested
- Phentermine/topiramate, low calorie diet
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentermine/topiramateDrug
Also called Qsymia
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.
low calorie dietOther
The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
| Study group | Role | What they receive |
|---|---|---|
| Phentermine/topiramate | Experimental | All subjects enrolled in the study will be placed on the study medication. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post-operatively
Secondary outcomes (16)
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Measured: Pre-operatively and 24 months post-operatively
Body Mass Index
Resulting body mass index
Measured: 24 months post-operatively
Percent Body Fat
Change in percent body fat
Measured: 24 months post-operatively
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Measured: 24 months post-operatively
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Measured: Pre-operatively and 12 months post-operatively
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Measured: Pre-operatively and 6 months post-operatively
Percent Weight Change
Percent weight loss achieved before and after surgery while taking the medication, Qsymia.
Measured: Pre-operatively and 3 months post-operatively
Body Mass Index
Resulting body mass index
Measured: 12 months post-operatively
Body Mass Index
Resulting body mass index
Measured: 6 months post-operatively
Body Mass Index
Resulting body mass index
Measured: 3 months post-operatively
Percent Body Fat
Change in percent body fat
Measured: 12 months post-operatively
Percent Body Fat
Change in percent body fat
Measured: 6 months post-operatively
Percent Body Fat
Change in percent body fat
Measured: 3 months post-operatively
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Measured: 12 months post-operatively
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Measured: 6 months post-operatively
Resting Metabolic Rate
Resting metabolic rate via indirect calorimetry
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- VIVUS LLC
- Responsible party
- Sponsor
- Investigators
- Jamy D Ard, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301416
- Sponsor's protocol ID
- IRB00027047
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2014
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qsymia as an Adjunct to Surgical Therapy in the Superobese
- ClinicalTrials.gov ID
- NCT02301416
- Acronym / sponsor ID
- IRB00027047
- Conditions
- Obesity, Metabolic Surgery, Weight Loss, Bariatric Surgery Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- VIVUS LLC
- Study start
- Dec 2014 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Posted 4 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phentermine/topiramate | Experimental | Drug: Phentermine/topiramate, Other: low calorie dietAll subjects enrolled in the study will be placed on the study medication. |
| Historical Control | No intervention | –Historical controls who had sleeve gastrectomy during the same time frame without phentermine/topiramate treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phentermine/topiramateAlso: QsymiaMinimum 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. | Drug | Phentermine/topiramate |
| low calorie dietThe low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions. | Other | Phentermine/topiramate |
Primary outcome
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.
16 secondary outcomes
Percent Weight Change
Time frame: Pre-operatively and 24 months post-operatively
Body Mass Index
Time frame: 24 months post-operatively
Percent Body Fat
Time frame: 24 months post-operatively
Resting Metabolic Rate
Time frame: 24 months post-operatively
Percent Weight Change
Time frame: Pre-operatively and 12 months post-operatively
Percent Weight Change
Time frame: Pre-operatively and 6 months post-operatively
Percent Weight Change
Time frame: Pre-operatively and 3 months post-operatively
Body Mass Index
Time frame: 12 months post-operatively
Body Mass Index
Time frame: 6 months post-operatively
Body Mass Index
Time frame: 3 months post-operatively
Percent Body Fat
Time frame: 12 months post-operatively
Percent Body Fat
Time frame: 6 months post-operatively
Percent Body Fat
Time frame: 3 months post-operatively
Resting Metabolic Rate
Time frame: 12 months post-operatively
Resting Metabolic Rate
Time frame: 6 months post-operatively
Resting Metabolic Rate
Time frame: 3 months post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamy D Ard, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phentermine/topiramate and low calorie diet in people with Obesity and Metabolic Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.