Obesity, MorbidPhase 2NCT04095104
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
A Phase 2 study testing Phentermine and Immediate Release Topiramate in people with Obesity, Morbid and Bariatric Surgery, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery, Adolescent
- What is being tested?
- Phentermine and Immediate Release Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 25 Jan 2022
- 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 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Status post sleeve gastrectomy or roux-en-y gastric bypass
- At 6 months after bariatric surgery, has not achieved >= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (>=120% of 95th%ile or BMI >=35kg/m2 for 12-17yo; BMI >=35kg/m2 for 18-24yo)
Who cannot join
- Absolute contraindication to phentermine or topiramate (i.e. phentermine:
- history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)
- Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)
- Use of anti-obesity medication within 6 months of screening
- Initiation of a new medication associated with weight loss or gain within 30 days of screening
- Type 2 diabetes mellitus
Show all 16Show fewer
- Hypothalamic obesity
- Unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety
- History of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening
- History of schizophrenia
- Severe hepatic impairment (ALT >10x upper limit of normal or known synthetic liver dysfunction)
- Moderate or severe renal impairment (GFR <30mL/min/1.73m2)
- Dosage change to hypertension, dyslipidemia, depression, or anxiety medication <4 weeks prior to study enrollment
- Contraception started <7 days prior to study enrollment
- Current pregnancy/plans to become pregnant within 16 weeks from study drug start date
- Females without a long acting reversible contraceptive (LARC) who do not commit to using 2 forms of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study
The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).
- Conditions
- Obesity, Morbid, Bariatric Surgery, Adolescent, Young Adult, Drug Therapy
- Being tested
- Phentermine, Immediate Release Topiramate, Placebo for Phentermine, Placebo for Immediate Release Topiramate
- Keywords
- Pilot, Feasibility, Initial Efficacy, Randomized Controlled Trial
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhentermineDrug
Also called Lomaira, Adipex-P, C045TQL4WP, 2-methyl-1-phenylpropan-2-amine
Phentermine tablet
Immediate Release TopiramateDrug
Also called Topamax, 0H73WJJ391, [(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methyl sulfamate
Topiramate tablet
Placebo for PhentermineDrug
Compounded tablet to mimic phentermine 8mg tablet
Placebo for Immediate Release TopiramateDrug
Compounded tablet to mimic immediate release topiramate 25mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Phentermine & Topiramate | Experimental | Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration:
4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning
+
Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning
+
Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits) Receives: Drug: Phentermine; Drug: Immediate Release Topiramate |
| Placebo Drugs | Placebo comparator | Placebo Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning
+
Placebo Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning
+
Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits) Receives: Drug: Placebo for Phentermine; Drug: Placebo for Immediate Release Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
(Number enrolled divided by number eligible) x 100
Measured: 6 months
Dropout Rate
Number who do not complete the study divided by number enrolled
Measured: 24 months
Number of Participants Adherent to Study Drugs
Presence of amphetamine in the urine at any study visit
Measured: 12 weeks
Frequency of Adverse Events
Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.
Measured: 24 months
Secondary outcomes (24)
Percent BMI Change
(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100
Measured: Baseline and 12 weeks
Percent Weight Change
(Baseline weight - weight at 12 weeks)/Baseline weight x 100
Measured: Baseline and 12 weeks
Change in BMI Percent of the 95th%Ile
(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)
Measured: Baseline and 12 weeks
Change in Heart Rate
(Heart rate at baseline - Heart rate at 12 weeks)
Measured: Baseline and 12 weeks
Change in Systolic Blood Pressure
Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks
Measured: Baseline and 12 weeks
Change in Diastolic Blood Pressure
Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks
Measured: Baseline and 12 weeks
Change in Total Cholesterol (mg/dL)
Total cholesterol at baseline - Total cholesterol at 12 weeks
Measured: Baseline and 12 weeks
Change in Triglycerides (mg/dL)
Triglycerides at baseline - Triglycerides at 12 weeks
Measured: Baseline and 12 weeks
Change in LDL Cholesterol (mg/dL)
LDL at baseline - LDL at 12 weeks
Measured: Baseline and 12 weeks
Change in HDL Cholesterol (mg/dL)
HDL at baseline - HDL at 12 weeks
Measured: Baseline and 12 weeks
Change in Alanine Aminotransferase (ALT) (U/L)
ALT at baseline - ALT at 12 weeks
Measured: Baseline and 12 weeks
Change in Hemoglobin A1c (HbA1c) (%)
HbA1c at baseline - HbA1c at 12 weeks
Measured: Baseline and 12 weeks
Change in % Fat Mass
% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA
Measured: Baseline and 12 weeks
Change in Resting Metabolic Rate (RMR)
RMR at baseline - RMR at 12 weeks measured by indirect calorimetry
Measured: Baseline and 12 weeks
Change in Daily Kilocalorie Intake
The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day.
Measured: Baseline and 12 weeks
Change in Hunger
The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period.
Measured: Baseline and 12 weeks
Change in Satiety
The adolescent/young adult will report subjective satiety 30 minutes after each meal and snack for 24 hours using a visual analogue slider scale (0= no fullness, 100 = most full) and this score will be averaged over the 24 hour period.
Measured: Baseline and 12 weeks
Change in Eating in the Absence of Hunger
Validated questionnaire: Eating in the Absence of Hunger-Parent (EAH-P) completed by the parent/guardian about their adolescent/young adult. This measure has 14 items.
Each item is on a 5-point Likert scale ranging from 1= "never" to 5= "always". A higher score indicates more eating in the absence of hunger.
Total scores (minimum 14 to maximum 70) are calculated by taking the sum of the 14 items at each time point.
The mean change in total scores by group are presented.
Measured: Baseline and 12 weeks
Change in Cognitive Restraint
The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item questionnaire that assesses 3 eating behaviors: Cognitive Dietary Restraint, Disinhibited Eating, and Predisposition to hunger. Cognitive restraint was the domain of highest interest for this study and is reported here. Higher scores in each domain indicate more of each of those behaviors.
The cognitive restraint domain score is calculated by taking the average of the 21 items in that domain. Each of the 21 items has a score of 0 or 1.
MINIMUM mean score for this measure is: 0 and MAXIMUM mean score is 1. MINIMUM total score for this measure is: 0 and MAXIMUM total score is 21 (relevant to the "Full Range" in the data table below)
Measured: Baseline and 12 weeks
Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report
"Impact of Weight on Quality of Life-Kids" questionnaire will be completed by the adolescents age <=19.
Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.
Higher scores indicate higher quality of life.
Measured: Baseline and 12 weeks
Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult
"Impact of Weight on Quality of Life-Kids Parent Proxy" questionnaire will be completed by the parent of the adolescent/young adult.
Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.
Higher scores indicate higher quality of life.
Measured: Baseline and 12 weeks
Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report
PedsQL instrument will be completed by the adolescent/young adult. The CHANGE in total scale score is reported here. The total scale score at each time point ranges from a MIN of 0 to a MAX of 100.
Items are rated on a 0-4 scale. Items are reverse scored and linearly transformed to a 0-100 scale, such that 0=100, 1=75, 2=50, 3=25, and 4=0.
Scale Scores are calculated as the sum of the items over the number of items answered.
Higher scores indicated better health-related quality of life.
Measured: Baseline and 12 weeks
Change in Depression
The adolescent/young adult will complete the 20-item Center for Epidemiologic Studies Depression Scale (CES-D).
Each item is rated on a 0 to 3 scale (positive items are reverse scored). Minimum score is 0 and maximum is 60. Higher scores indicate more depressive symptoms. Total score is calculated by summing each of the 20 individual items scores.
Measured: Baseline and 12 weeks
Participant Satisfaction: Questionnaire
The participating family will be asked to complete a satisfaction questionnaire that will assess reasons for participation, experience during study visits, satisfaction with the effect of the study drug, ease of communication with study staff, and study burden.
The outcome presented here is the average of the parent and adolescent/young adult dyad's response to the statement: "My overall experience was positive" [1=Strongly disagree, 5=Strongly agree]
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start15 Jan 2020
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
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 Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel assignment where the experimental arm will receive active drugs + standard of care and the control arm will receive placebo drugs + standard of care.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado- Clinical and Translational Sciences Institute, University of Colorado- Nutrition Obesity Research Center
- Responsible party
- Sponsor
- Investigators
- Jaime M Moore, MD, MPH, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095104
- Sponsor's protocol ID
- 18-2793
- Other IDs
- 5P30DK048520-24
- Status last verified
- May 2025
- First submitted
- 17 Sep 2019
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in obesity. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04095104
- Acronym / sponsor ID
- 18-2793
- Conditions
- Obesity, Morbid, Bariatric Surgery, Adolescent, Young Adult, Drug Therapy
- Keywords
- Pilot, Feasibility, Initial Efficacy, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado- Clinical and Translational Sciences Institute, University of Colorado- Nutrition Obesity Research Center
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment where the experimental arm will receive active drugs + standard of care and the control arm will receive placebo drugs + standard of care.
| Arm | Type | Receives |
|---|---|---|
| Phentermine & Topiramate | Experimental | Drug: Phentermine, Drug: Immediate Release TopiramatePhentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning + Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning + Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits) |
| Placebo Drugs | Placebo comparator | Drug: Placebo for Phentermine, Drug: Placebo for Immediate Release TopiramatePlacebo Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning + Placebo Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning + Standard of Care (multidisciplinary postoperative bariatric surgery clinic visits) |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Status post sleeve gastrectomy or roux-en-y gastric bypass
- At 6 months after bariatric surgery, has not achieved >= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (>=120% of 95th%ile or BMI >=35kg/m2 for 12-17yo; BMI >=35kg/m2 for 18-24yo)
Key exclusion criteria (16 listed)
- Absolute contraindication to phentermine or topiramate (i.e. phentermine:
- history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)
- Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)
- Use of anti-obesity medication within 6 months of screening
- Initiation of a new medication associated with weight loss or gain within 30 days of screening
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 |
|---|---|---|
| PhentermineAlso: Lomaira, Adipex-P, C045TQL4WP, 2-methyl-1-phenylpropan-2-aminePhentermine tablet | Drug | Phentermine & Topiramate |
| Immediate Release TopiramateAlso: Topamax, 0H73WJJ391, [(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methyl sulfamateTopiramate tablet | Drug | Phentermine & Topiramate |
| Placebo for PhentermineCompounded tablet to mimic phentermine 8mg tablet | Drug | Placebo Drugs |
| Placebo for Immediate Release TopiramateCompounded tablet to mimic immediate release topiramate 25mg tablet | Drug | Placebo Drugs |
Primary outcome
Enrollment Rate
Time frame: 6 months
(Number enrolled divided by number eligible) x 100
Dropout Rate
Time frame: 24 months
Number who do not complete the study divided by number enrolled
Number of Participants Adherent to Study Drugs
Time frame: 12 weeks
Presence of amphetamine in the urine at any study visit
Frequency of Adverse Events
Time frame: 24 months
Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.
24 secondary outcomes
Percent BMI Change
Time frame: Baseline and 12 weeks
Percent Weight Change
Time frame: Baseline and 12 weeks
Change in BMI Percent of the 95th%Ile
Time frame: Baseline and 12 weeks
Change in Heart Rate
Time frame: Baseline and 12 weeks
Change in Systolic Blood Pressure
Time frame: Baseline and 12 weeks
Change in Diastolic Blood Pressure
Time frame: Baseline and 12 weeks
Change in Total Cholesterol (mg/dL)
Time frame: Baseline and 12 weeks
Change in Triglycerides (mg/dL)
Time frame: Baseline and 12 weeks
Change in LDL Cholesterol (mg/dL)
Time frame: Baseline and 12 weeks
Change in HDL Cholesterol (mg/dL)
Time frame: Baseline and 12 weeks
Change in Alanine Aminotransferase (ALT) (U/L)
Time frame: Baseline and 12 weeks
Change in Hemoglobin A1c (HbA1c) (%)
Time frame: Baseline and 12 weeks
Change in % Fat Mass
Time frame: Baseline and 12 weeks
Change in Resting Metabolic Rate (RMR)
Time frame: Baseline and 12 weeks
Change in Daily Kilocalorie Intake
Time frame: Baseline and 12 weeks
Change in Hunger
Time frame: Baseline and 12 weeks
Change in Satiety
Time frame: Baseline and 12 weeks
Change in Eating in the Absence of Hunger
Time frame: Baseline and 12 weeks
Change in Cognitive Restraint
Time frame: Baseline and 12 weeks
Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report
Time frame: Baseline and 12 weeks
Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult
Time frame: Baseline and 12 weeks
Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report
Time frame: Baseline and 12 weeks
Change in Depression
Time frame: Baseline and 12 weeks
Participant Satisfaction: Questionnaire
Time frame: At 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in obesity. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Jaime M Moore, MD, MPH principal investigator
University of Colorado School of Medicine
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 and Immediate Release Topiramate in people with Obesity, Morbid and Bariatric Surgery, run by University of Colorado, Denver 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 2 inclusion and 16 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 23 May 2025. 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. Some participants in this study may receive a placebo. 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 23 May 2025). 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?
Enrollment Rate (time frame: 6 months). The study lists 4 primary outcomes in all. 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 23 May 2025.