Adolescent, Bariatric Surgery, Drug Therapy, Obesity, Morbid, Young Adult
Conditions
Keywords
Pilot, Feasibility, Initial Efficacy, Randomized Controlled Trial
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).
Interventions
DRUGPhentermine
Phentermine tablet
DRUGImmediate Release Topiramate
Topiramate tablet
DRUGPlacebo for Phentermine
Compounded tablet to mimic phentermine 8mg tablet
DRUGPlacebo for Immediate Release Topiramate
Compounded tablet to mimic immediate release topiramate 25mg tablet
Sponsors
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
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | 6 months | (Number enrolled divided by number eligible) x 100 |
| Dropout Rate | 24 months | Number who do not complete the study divided by number enrolled |
| Number of Participants Adherent to Study Drugs | 12 weeks | Presence of amphetamine in the urine at any study visit |
| Frequency of Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Baseline and 12 weeks | Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks |
| Change in Diastolic Blood Pressure | Baseline and 12 weeks | Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks |
| Change in Total Cholesterol (mg/dL) | Baseline and 12 weeks | Total cholesterol at baseline - Total cholesterol at 12 weeks |
| Change in Triglycerides (mg/dL) | Baseline and 12 weeks | Triglycerides at baseline - Triglycerides at 12 weeks |
| Change in LDL Cholesterol (mg/dL) | Baseline and 12 weeks | LDL at baseline - LDL at 12 weeks |
| Change in HDL Cholesterol (mg/dL) | Baseline and 12 weeks | HDL at baseline - HDL at 12 weeks |
| Change in Alanine Aminotransferase (ALT) (U/L) | Baseline and 12 weeks | ALT at baseline - ALT at 12 weeks |
| Change in Hemoglobin A1c (HbA1c) (%) | Baseline and 12 weeks | HbA1c at baseline - HbA1c at 12 weeks |
| Change in % Fat Mass | Baseline and 12 weeks | % Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA |
| Change in Resting Metabolic Rate (RMR) | Baseline and 12 weeks | RMR at baseline - RMR at 12 weeks measured by indirect calorimetry |
| Percent BMI Change | Baseline and 12 weeks | (Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100 |
| Change in Hunger | Baseline and 12 weeks | 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. |
| Change in Satiety | Baseline and 12 weeks | 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. |
| Change in Eating in the Absence of Hunger | Baseline and 12 weeks | 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. |
| Change in Cognitive Restraint | Baseline and 12 weeks | 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) |
| Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report | Baseline and 12 weeks | 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 Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult | Baseline and 12 weeks | 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 General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report | Baseline and 12 weeks | 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. |
| Change in Depression | Baseline and 12 weeks | 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 | At 12 weeks | 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 \[1=Strongly disagree, 5=Strongly agree\] |
| Change in Daily Kilocalorie Intake | Baseline and 12 weeks | 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. |
| Percent Weight Change | Baseline and 12 weeks | (Baseline weight - weight at 12 weeks)/Baseline weight x 100 |
| Change in BMI Percent of the 95th%Ile | Baseline and 12 weeks | (Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks) |
| Change in Heart Rate | Baseline and 12 weeks | (Heart rate at baseline - Heart rate at 12 weeks) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phentermine & Topiramate Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care. | 6 |
| Placebo Participants were randomized to receive placebo tablets (compounded to look like phentermine and topiramate) plus standard post-bariatric care. | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Phentermine & Topiramate |
|---|---|---|---|
| Age, Continuous | 17.9 years | 17.3 years | 16.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 |
Outcome results
Primary
Dropout Rate
Number who do not complete the study divided by number enrolled
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Participants Before Randomization | Dropout Rate | 0 percentage who withdrew among enrolled |
| Placebo | Dropout Rate | 7.7 percentage who withdrew among enrolled |
Primary
Enrollment Rate
(Number enrolled divided by number eligible) x 100
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Eligible Participants Before Randomization | Enrollment Rate | 19 percentage of participants |
Primary
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.
Time frame: 24 months
Population: The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Frequency of Adverse Events | 16 unique adverse events per participant |
| Placebo | Frequency of Adverse Events | 8 unique adverse events per participant |
Primary
Number of Participants Adherent to Study Drugs
Presence of amphetamine in the urine at any study visit
Time frame: 12 weeks
Population: The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants Before Randomization | Number of Participants Adherent to Study Drugs | 5 Participants |
| Placebo | Number of Participants Adherent to Study Drugs | 0 Participants |
Secondary
Change in Alanine Aminotransferase (ALT) (U/L)
ALT at baseline - ALT at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Alanine Aminotransferase (ALT) (U/L) | 3.33 U/L |
| Placebo | Change in Alanine Aminotransferase (ALT) (U/L) | 0.83 U/L |
Secondary
Change in BMI Percent of the 95th%Ile
(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)
Time frame: Baseline and 12 weeks
Population: For 1 member of the active group and 2 members of the placebo group, it was not appropriate to calculate a % above the 95th%ile either because BMI was \<95th%ile or they were \>19 completed years at the time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in BMI Percent of the 95th%Ile | -6.2 percentile change |
| Placebo | Change in BMI Percent of the 95th%Ile | 2 percentile change |
Secondary
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)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Cognitive Restraint | -0.83 units on a scale |
| Placebo | Change in Cognitive Restraint | -0.33 units on a scale |
Secondary
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Daily Kilocalorie Intake | -339.32 kilocalories |
| Placebo | Change in Daily Kilocalorie Intake | 94.85 kilocalories |
Secondary
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Depression | 6.5 units on a scale |
| Placebo | Change in Depression | -2.5 units on a scale |
Secondary
Change in Diastolic Blood Pressure
Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Diastolic Blood Pressure | -1.33 mmHg |
| Placebo | Change in Diastolic Blood Pressure | 4.17 mmHg |
Secondary
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Eating in the Absence of Hunger | -7.3 units on a scale |
| Placebo | Change in Eating in the Absence of Hunger | -0.5 units on a scale |
Secondary
Change in % Fat Mass
% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in % Fat Mass | -1.0 percentage of fat mass |
| Placebo | Change in % Fat Mass | 1.0 percentage of fat mass |
Secondary
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report | -3.67 units on a transformed scale |
| Placebo | Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report | 3.17 units on a transformed scale |
Secondary
Change in HDL Cholesterol (mg/dL)
HDL at baseline - HDL at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in HDL Cholesterol (mg/dL) | -3.83 mg/dL |
| Placebo | Change in HDL Cholesterol (mg/dL) | -0.17 mg/dL |
Secondary
Change in Heart Rate
(Heart rate at baseline - Heart rate at 12 weeks)
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Heart Rate | 2.89 beats per minute |
| Placebo | Change in Heart Rate | -0.83 beats per minute |
Secondary
Change in Hemoglobin A1c (HbA1c) (%)
HbA1c at baseline - HbA1c at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Hemoglobin A1c (HbA1c) (%) | 0.05 Percentage of glycated hemoglobin |
| Placebo | Change in Hemoglobin A1c (HbA1c) (%) | 0.10 Percentage of glycated hemoglobin |
Secondary
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.
Time frame: Baseline and 12 weeks
Population: VAS hunger ratings were missing from 1 participant in each the active and placebo groups
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Hunger | -10.76 units on a scale |
| Placebo | Change in Hunger | 0.20 units on a scale |
Secondary
Change in LDL Cholesterol (mg/dL)
LDL at baseline - LDL at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in LDL Cholesterol (mg/dL) | -12.73 mg/dL |
| Placebo | Change in LDL Cholesterol (mg/dL) | 7.43 mg/dL |
Secondary
Change in Resting Metabolic Rate (RMR)
RMR at baseline - RMR at 12 weeks measured by indirect calorimetry
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Resting Metabolic Rate (RMR) | -97.8 kilocalories per day |
| Placebo | Change in Resting Metabolic Rate (RMR) | -32.1 kilocalories per day |
Secondary
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.
Time frame: Baseline and 12 weeks
Population: VAS missing from 1 participant each in the active and placebo groups
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Satiety | -1.8 units on a scale |
| Placebo | Change in Satiety | -0.2 units on a scale |
Secondary
Change in Systolic Blood Pressure
Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Systolic Blood Pressure | 3.33 mmHg |
| Placebo | Change in Systolic Blood Pressure | 0.78 mmHg |
Secondary
Change in Total Cholesterol (mg/dL)
Total cholesterol at baseline - Total cholesterol at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Total Cholesterol (mg/dL) | -18 mg/dL |
| Placebo | Change in Total Cholesterol (mg/dL) | 6 mg/dL |
Secondary
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report | -0.38 units on a transformed scale |
| Placebo | Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report | 3.61 units on a transformed scale |
Secondary
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.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult | 4.94 units on a transformed scale |
| Placebo | Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult | -0.62 units on a transformed scale |
Secondary
Change in Triglycerides (mg/dL)
Triglycerides at baseline - Triglycerides at 12 weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Change in Triglycerides (mg/dL) | -7.17 mg/dL |
| Placebo | Change in Triglycerides (mg/dL) | -6.33 mg/dL |
Secondary
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 \[1=Strongly disagree, 5=Strongly agree\]
Time frame: At 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Participant Satisfaction: Questionnaire | 4.75 units on a scale |
| Placebo | Participant Satisfaction: Questionnaire | 4.75 units on a scale |
Secondary
Percent BMI Change
(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Percent BMI Change | -3.61 percent change |
| Placebo | Percent BMI Change | 1.89 percent change |
Secondary
Percent Weight Change
(Baseline weight - weight at 12 weeks)/Baseline weight x 100
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Eligible Participants Before Randomization | Percent Weight Change | -4.72 percent change |
| Placebo | Percent Weight Change | 0.83 percent change |