Back to resultsAdjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Primary Purpose
Obesity, Morbid, Bariatric Surgery, Adolescent
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Phentermine
Immediate Release Topiramate
Placebo for Phentermine
Placebo for Immediate Release Topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring Pilot, Feasibility, Initial Efficacy, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Children's Hospital Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Phentermine & Topiramate
Placebo Drugs
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Enrollment Rate
Number enrolled divided by number eligible
Dropout Rate
Number who do not complete the study divided by number enrolled
Adherence to Study Drugs
Percentage of missed doses (pill count); Presence/Absence of amphetamine in the urine
Frequency of drug-related adverse events
Count and description of adverse events possibly or definitely related to the study drugs. Elicited using a standardized checklist during 3 study phone calls and 3 in-person study visits, laboratory monitoring of serum bicarbonate, and comprehensive review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.
Secondary Outcome Measures
Percent weight change
(Baseline weight - Weight at 12 weeks)/Baseline weight x 100
Percent BMI change
(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100
Change in BMI percent of the 95th%ile
(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)
Change in heart rate
(Heart rate at baseline - Heart rate at 12 weeks)
Change in systolic blood pressure
Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks
Change in diastolic blood pressure
Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks
Change in total cholesterol (mg/dL)
Total cholesterol at baseline - Total cholesterol at 12 weeks
Change in triglycerides (mg/dL)
Triglycerides at baseline - Triglycerides at 12 weeks
Change in LDL cholesterol (mg/dL)
LDL at baseline - LDL at 12 weeks
Change in HDL cholesterol (mg/dL)
HDL at baseline - HDL at 12 weeks
Change in alanine aminotransferase (ALT) (U/L)
ALT at baseline - ALT at 12 weeks
Change in hemoglobin A1c (HbA1c) (%)
HbA1c at baseline - HbA1c at 12 weeks
Change in % fat mass
% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA
Change in resting metabolic rate (RMR)
RMR at baseline - RMR at 12 weeks measured by indirect calorimetry
Change in Dietary Intake
The adolescent/young adult will complete a dietary record on 3 consecutive days (2 weekdays, 1 weekend day) based on standardized protocols for dietary assessment. Total caloric intake, macronutrient, and micronutrient breakdown will be assessed.
Change in Hunger
The adolescent/young adult will report hunger before each meal and snack for 24 hours using a 100mm visual analogue scale (0= no hunger, 100 = most hunger)
Change in Satiety
The adolescent/young adult will report satiety before each meal and snack for 24 hours using a 100mm visual analogue scale (0= no fullness, 100= most full)
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 and sub scales are calculated by taking the average of the items. Total score measures the overall construct "Eating in the Absence of Hunger" Subscales include: "External Cues" (4 items); "Response to negative affect" (6 items); "Fatigue/Boredom" (4 items).
Change in Cognitive Restraint, Disinhibited Eating, and Predisposition to Hunger
The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item measure that is divided into 2 parts, and assesses 3 eating behaviors: 1) Cognitive Dietary Restraint (20 items), 2) Disinhibited Eating (16 items), and 3) Predisposition to hunger (15 items). Higher scores in each domain indicate more of each of those behaviors.
The minimum score for factors 1, 2, and 3 are: 0, 0, and 0. The maximum score for factors 1, 2, and 3 are: 20, 16, and 15 Part I includes items 1-36 rated as either True (1) or False (0) Part II includes items 37-51 and is rated on a 4-point Likert-like scale with one exception- item 50 is rated on a 6-point scale.
Scores for each of the three eating behaviors are calculated by taking the average of the items, and are most commonly reported separately, not as a total score.
Change in Weight Related Quality of Life- Adolescent
"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.
Change in Weight Related Quality of Life- Parent
"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.
Change in Weight Related Quality of Life- Young adult
"Impact of Weight on Quality of Life-Lite" questionnaire will be completed by the young adult age >=20.
Total and each of the 5 sub scales (Physical function-11 items, Self Esteem-7 items, Sexual Life-4 items, Public distress-5 items, and Work-4 items) range from a minimum score of 0 to a maximum of 100.
Higher scores indicate higher quality of life.
Change in General Health Related Quality of Life: PedsQL instrument
PedsQL instrument will be completed by the adolescent/young adult. There are 4 scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items) and 3 Summary Scores: Total Scale Score (23 items), Physical Health Summary Score (8 items), and Psychosocial Health Summary Score (15 items).
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.
Higher scores indicated better health-related quality of life. Scale Scores are calculated as the sum of the items over the number of items answered.
Psychosocial Health Summary Score is calculated as the sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales.
Physical Health Summary Score is the same as the Physical Functioning Scale Score.
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.
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.
Full Information
NCT ID
NCT04095104
First Posted
September 17, 2019
Last Updated
March 7, 2022
Sponsor
Jaime Moore, MD MPH
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
1. Study Identification
Unique Protocol Identification Number
NCT04095104
Brief Title
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Official Title
Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jaime Moore, MD MPH
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Bariatric Surgery, Adolescent, Young Adult, Drug Therapy
Keywords
Pilot, Feasibility, Initial Efficacy, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
At baseline, each participant will be randomized 1:1 to either 12 weeks of phentermine, topiramate and standard of care or 12 weeks of phentermine placebo, topiramate placebo, and standard of care. This randomization will be blinded to the participant, investigator, care providers, and outcomes assessor for the duration of the study.
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phentermine & Topiramate
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo Drugs
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Phentermine
Other Intervention Name(s)
Lomaira, Adipex-P, C045TQL4WP, 2-methyl-1-phenylpropan-2-amine
Intervention Description
Phentermine tablet
Intervention Type
Drug
Intervention Name(s)
Immediate Release Topiramate
Other Intervention Name(s)
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
Intervention Description
Topiramate tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for Phentermine
Intervention Description
Compounded tablet to mimic phentermine 8mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for Immediate Release Topiramate
Intervention Description
Compounded tablet to mimic immediate release topiramate 25mg tablet
Primary Outcome Measure Information:
Title
Enrollment Rate
Description
Number enrolled divided by number eligible
Time Frame
24 months
Title
Dropout Rate
Description
Number who do not complete the study divided by number enrolled
Time Frame
24 months
Title
Adherence to Study Drugs
Description
Percentage of missed doses (pill count); Presence/Absence of amphetamine in the urine
Time Frame
12 weeks
Title
Frequency of drug-related adverse events
Description
Count and description of adverse events possibly or definitely related to the study drugs. Elicited using a standardized checklist during 3 study phone calls and 3 in-person study visits, laboratory monitoring of serum bicarbonate, and comprehensive review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Percent weight change
Description
(Baseline weight - Weight at 12 weeks)/Baseline weight x 100
Time Frame
Baseline and 12 weeks
Title
Percent BMI change
Description
(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100
Time Frame
Baseline and 12 weeks
Title
Change in BMI percent of the 95th%ile
Description
(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)
Time Frame
Baseline and 12 weeks
Title
Change in heart rate
Description
(Heart rate at baseline - Heart rate at 12 weeks)
Time Frame
Baseline and 12 weeks
Title
Change in systolic blood pressure
Description
Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in diastolic blood pressure
Description
Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in total cholesterol (mg/dL)
Description
Total cholesterol at baseline - Total cholesterol at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in triglycerides (mg/dL)
Description
Triglycerides at baseline - Triglycerides at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in LDL cholesterol (mg/dL)
Description
LDL at baseline - LDL at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in HDL cholesterol (mg/dL)
Description
HDL at baseline - HDL at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in alanine aminotransferase (ALT) (U/L)
Description
ALT at baseline - ALT at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in hemoglobin A1c (HbA1c) (%)
Description
HbA1c at baseline - HbA1c at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Change in % fat mass
Description
% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA
Time Frame
Baseline and 12 weeks
Title
Change in resting metabolic rate (RMR)
Description
RMR at baseline - RMR at 12 weeks measured by indirect calorimetry
Time Frame
Baseline and 12 weeks
Title
Change in Dietary Intake
Description
The adolescent/young adult will complete a dietary record on 3 consecutive days (2 weekdays, 1 weekend day) based on standardized protocols for dietary assessment. Total caloric intake, macronutrient, and micronutrient breakdown will be assessed.
Time Frame
Baseline and 12 weeks
Title
Change in Hunger
Description
The adolescent/young adult will report hunger before each meal and snack for 24 hours using a 100mm visual analogue scale (0= no hunger, 100 = most hunger)
Time Frame
Baseline and 12 weeks
Title
Change in Satiety
Description
The adolescent/young adult will report satiety before each meal and snack for 24 hours using a 100mm visual analogue scale (0= no fullness, 100= most full)
Time Frame
Baseline and 12 weeks
Title
Change in Eating in the Absence of Hunger
Description
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 and sub scales are calculated by taking the average of the items. Total score measures the overall construct "Eating in the Absence of Hunger" Subscales include: "External Cues" (4 items); "Response to negative affect" (6 items); "Fatigue/Boredom" (4 items).
Time Frame
Baseline and 12 weeks
Title
Change in Cognitive Restraint, Disinhibited Eating, and Predisposition to Hunger
Description
The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item measure that is divided into 2 parts, and assesses 3 eating behaviors: 1) Cognitive Dietary Restraint (20 items), 2) Disinhibited Eating (16 items), and 3) Predisposition to hunger (15 items). Higher scores in each domain indicate more of each of those behaviors.
The minimum score for factors 1, 2, and 3 are: 0, 0, and 0. The maximum score for factors 1, 2, and 3 are: 20, 16, and 15 Part I includes items 1-36 rated as either True (1) or False (0) Part II includes items 37-51 and is rated on a 4-point Likert-like scale with one exception- item 50 is rated on a 6-point scale.
Scores for each of the three eating behaviors are calculated by taking the average of the items, and are most commonly reported separately, not as a total score.
Time Frame
Baseline and 12 weeks
Title
Change in Weight Related Quality of Life- Adolescent
Description
"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.
Time Frame
Baseline and 12 weeks
Title
Change in Weight Related Quality of Life- Parent
Description
"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.
Time Frame
Baseline and 12 weeks
Title
Change in Weight Related Quality of Life- Young adult
Description
"Impact of Weight on Quality of Life-Lite" questionnaire will be completed by the young adult age >=20.
Total and each of the 5 sub scales (Physical function-11 items, Self Esteem-7 items, Sexual Life-4 items, Public distress-5 items, and Work-4 items) range from a minimum score of 0 to a maximum of 100.
Higher scores indicate higher quality of life.
Time Frame
Baseline and 12 weeks
Title
Change in General Health Related Quality of Life: PedsQL instrument
Description
PedsQL instrument will be completed by the adolescent/young adult. There are 4 scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items) and 3 Summary Scores: Total Scale Score (23 items), Physical Health Summary Score (8 items), and Psychosocial Health Summary Score (15 items).
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.
Higher scores indicated better health-related quality of life. Scale Scores are calculated as the sum of the items over the number of items answered.
Psychosocial Health Summary Score is calculated as the sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales.
Physical Health Summary Score is the same as the Physical Functioning Scale Score.
Time Frame
Baseline and 12 weeks
Title
Change in Depression
Description
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.
Time Frame
Baseline and 12 weeks
Title
Participant Satisfaction: questionnaire
Description
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.
Time Frame
At 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime M Moore, MD, MPH
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
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