Obesity, AdolescentPhase 2NCT05834062
Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity
A Phase 2 study testing Qsymia and lifestyle management therapy in people with Obesity, Adolescent, run by University of Minnesota at 1 site in United States.
Trial summary
This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- Qsymia and lifestyle management therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to Aug 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16 to less than 22 years at screening
- BMI >/= 25 to < 30 kg/m^2
- Family history of obesity defined as one biological parent with severe obesity (BMI >/= 35) and/or two biological parents with obesity (BMI >/= 30)
- Age 16 or 17 years old must also have an obesity-related complication/co-morbidity defined as elevated blood pressure (>/= 130 and/or >/= 80 milligrams of mercury [mmHg]) or current use of anti-hypertensive medication, dyslipidemia (triglycerides >/= 150 milligrams/deciliter (mg/dL) and/or HDL cholesterol < 40 mg/dL or current use of cholesterol-lowering medication, diagnosis of obstructive sleep apnea
Who cannot join
- Tanner stage 1-4
- Diabetes (1 or 2)
- Current or recent (< 6 months prior to enrollment) use of anti-obesity medication(s) and other weight-altering medication(s) (e.g.,, atypical antipsychotics, attention-deficit hyperactivity disorder [ADHD] stimulant)
- Previous bariatric surgery
- Current or recent (< 6 months prior to enrollment) use of medication(s) to treat insulin resistance
- Recent initiation (< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s)
Show all 33Show fewer
- History of glaucoma
- Current or recent (< 14 days) use of monoamine oxidase inhibitor
- Known hypersensitivity to sympathomimetic amines
- History of treatment with growth hormone
- Patient Health Questionnaire (PHQ) score of >/= 15
- Eating disorder symptoms within 6 months and/r any past medical diagnosis of eating disorder
- Major psychiatric disorder
- Unstable clinically-diagnosed depression
- History of suicide attempt
- Suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month
- Current pregnancy or breastfeeding
- Plans to become pregnant
- If sexually active, refusal to use 2 forms of birth control
- Tobacco use
- Alanine transaminase (ALT ) or Aspartate transaminase (AST) >/= 2.5 the upper limit of normal
- Bicarbonate < 18 micromoles per liter (mmol/L)
- Creatinine 1.2 mg/dL
- Creatinine clearance of < 50 microliters per minute [mL/min] (Schwartz formula)
- History of seizures
- Uncontrolled hypertension
- History of structural heart defect
- History of clinically significant arrhythmia
- Diagnosed monogenic obesity
- History of cholelithiasis
- History of nephrolithiasis
- Hyperthyroidism
- Untreated thyroid disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight
Read the detailed description
This study will evaluate the effects of preventative pharmacotherapy on body mass index (BMI), as well as incidence of obesity and normal weight, in adolescents at high risk of developing obesity. We hypothesize that 24 months of Qsymia vs. placebo, in combination with lifestyle-based weight gain prevention coaching, will prevent increases in BMI (primary endpoint). More participants in the placebo group will develop obesity (cross the BMI 30 kg/m2 threshold) and more in the Qsymia group will transition to normal weight (drop below a BMI of 25 kg/m2).
All participants, regardless of medication/placebo assignment, will receive the same foundational weight gain prevention coaching throughout the entire study. The weight gain prevention coaching will be delivered individually by master's level behavioral intervention specialists with expertise in nutrition, physical activity, and weight-related behavior change. The multi-phase prevention intervention will start with 6 weekly 30-minute coaching calls followed by monthly 15-minute check-in calls for the remainder of the first year. At the beginning of the second year, a series of 3, 30-minute coaching calls will be held to revisit the information covered in the initial coaching calls, followed by bi-monthly 15-minute check-in calls for the remainder of the second year. The calls will be conducted via videoconference substituted with phone calls if needed.
The weight gain prevention intervention will utilize empirically supported behavior change strategies to help promote healthy dietary intake, physical activity patterns, and modest weight loss and/or prevent weight gain among participants. The intervention is informed by several of our previous weight loss and maintenance trials and the work of others, including weight gain prevention trials in young adult populations. The core prevention intervention is based on a behavioral conceptualization of effective weight management that emphasizes: 1) identifying behaviors in need of change; 2) setting goals for change; 3) monitoring progress; 4) modifying environmental cues to facilitate change; and 5) modifying consequences to motivate change. The intervention will incorporate core behavior change strategies including self-monitoring, stimulus control, modeling, goal setting, and positive reinforcement, which were among the common behavior change elements identified across the 17 treatment arms used in the Early Adult Reduction of weight through LifestYle (EARLY) weight management trials that included the young adult weight gain prevention trials previously referenced.
- Conditions
- Obesity, Adolescent
- Being tested
- Qsymia and lifestyle management therapy, Placebo and lifestyle management therapy
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qsymia and lifestyle management therapyDrug
Qsymia will be used at 3.7g mg/23 mg for 12 weeks and then increased to 7.5 mg/46 mg for the remainder of the study. Participants will be offered lifestyle management therapy.
Placebo and lifestyle management therapyBehavioural
Placebo will be used in lieu of Qsymia to maintain the blind. Participants will be offered lifestyle management therapy.
| Study group | Role | What they receive |
|---|---|---|
| Medication arm | Experimental | Individuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment at 3.75 mg/23 mg orally once in the morning for 14 days, which will then be increased to 7.5 mg/46 mg orally once daily in the morning for the remainder of the trial. Participants who are unable to tolerate the dosing regimen will be maintained at the maximally tolerated dose. To further safeguard the risk/benefit balance we will utilize a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants will be reduced to the lowest-dose level (3.75 mg/23 mg) for 12 weeks. If the BMI remains below 20 kg/m2 at the lowest dose after 12 weeks, active treatment will be fully withdrawn.
Participants at the end of the study will be down-titrated gradually with instructions to take the medication every other day for 7 days before stopping treatment altogether. Receives: Drug: Qsymia and lifestyle management therapy |
| Placebo arm | Placebo comparator | Individuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment with a placebo (to keep the blind) and be asked to up-titrate the placebo dose after the first 14 days and then maintain the placebo dose for the remainder of the study.
Individuals who are unable to tolerate the dosing regimen will have a down-titration protocol (to maintain the blind) as described in the medication arm. Likewise, we will employ a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants would be reduced to the lowest dose level of placebo for 12 weeks. If the BMI remains below 20 kg/m2 after 12 weeks, placebo treatment will be fully withdrawn.
Individuals in the placebo arm will also have a placebo-based down-titration with instructions to take the placebo every other day for 7 days before stopping treatment altogether, to maintain the blind. Receives: Behavioral: Placebo and lifestyle management therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate effects of preventive pharmacotherapy and lifestyle-based weight gain prevention on body mass index between the medication arm and the placebo arm
Change in BMI
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start17 Oct 2023 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: The project was not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- This is a randomized, double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834062
- Sponsor's protocol ID
- PEDS-2022-31025
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data may be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity
- ClinicalTrials.gov ID
- NCT05834062
- Acronym / sponsor ID
- PEDS-2022-31025
- Conditions
- Obesity, Adolescent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 17 Oct 2023 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight
Detailed description
This study will evaluate the effects of preventative pharmacotherapy on body mass index (BMI), as well as incidence of obesity and normal weight, in adolescents at high risk of developing obesity. We hypothesize that 24 months of Qsymia vs. placebo, in combination with lifestyle-based weight gain prevention coaching, will prevent increases in BMI (primary endpoint). More participants in the placebo group will develop obesity (cross the BMI 30 kg/m2 threshold) and more in the Qsymia group will transition to normal weight (drop below a BMI of 25 kg/m2).
All participants, regardless of medication/placebo assignment, will receive the same foundational weight gain prevention coaching throughout the entire study. The weight gain prevention coaching will be delivered individually by master's level behavioral intervention specialists with expertise in nutrition, physical activity, and weight-related behavior change. The multi-phase prevention intervention will start with 6 weekly 30-minute coaching calls followed by monthly 15-minute check-in calls for the remainder of the first year. At the beginning of the second year, a series of 3, 30-minute coaching calls will be held to revisit the information covered in the initial coaching calls, followed by bi-monthly 15-minute check-in calls for the remainder of the second year. The calls will be conducted via videoconference substituted with phone calls if needed.
The weight gain prevention intervention will utilize empirically supported behavior change strategies to help promote healthy dietary intake, physical activity patterns, and modest weight loss and/or prevent weight gain among participants. The intervention is informed by several of our previous weight loss and maintenance trials and the work of others, including weight gain prevention trials in young adult populations. The core prevention intervention is based on a behavioral conceptualization of effective weight management that emphasizes: 1) identifying behaviors in need of change; 2) setting goals for change; 3) monitoring progress; 4) modifying environmental cues to facilitate change; and 5) modifying consequences to motivate change. The intervention will incorporate core behavior change strategies including self-monitoring, stimulus control, modeling, goal setting, and positive reinforcement, which were among the common behavior change elements identified across the 17 treatment arms used in the Early Adult Reduction of weight through LifestYle (EARLY) weight management trials that included the young adult weight gain prevention trials previously referenced.
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
- This is a randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Medication arm | Experimental | Drug: Qsymia and lifestyle management therapyIndividuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment at 3.75 mg/23 mg orally once in the morning for 14 days, which will then be increased to 7.5 mg/46 mg orally once daily in the morning for the remainder of the trial. Participants who are unable to tolerate the dosing regimen will be maintained at the maximally tolerated dose. To further safeguard the risk/benefit balance we will utilize a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants will be reduced to the lowest-dose level (3.75 mg/23 mg) for 12 weeks. If the BMI remains below 20 kg/m2 at the lowest dose after 12 weeks, active treatment will be fully withdrawn. Participants at the end of the study will be down-titrated gradually with instructions to take the medication every other day for 7 days before stopping treatment altogether. |
| Placebo arm | Placebo comparator | Behavioral: Placebo and lifestyle management therapyIndividuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment with a placebo (to keep the blind) and be asked to up-titrate the placebo dose after the first 14 days and then maintain the placebo dose for the remainder of the study. Individuals who are unable to tolerate the dosing regimen will have a down-titration protocol (to maintain the blind) as described in the medication arm. Likewise, we will employ a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants would be reduced to the lowest dose level of placebo for 12 weeks. If the BMI remains below 20 kg/m2 after 12 weeks, placebo treatment will be fully withdrawn. Individuals in the placebo arm will also have a placebo-based down-titration with instructions to take the placebo every other day for 7 days before stopping treatment altogether, to maintain the blind. |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16 to less than 22 years at screening
- BMI >/= 25 to < 30 kg/m^2
- Family history of obesity defined as one biological parent with severe obesity (BMI >/= 35) and/or two biological parents with obesity (BMI >/= 30)
- Age 16 or 17 years old must also have an obesity-related complication/co-morbidity defined as elevated blood pressure (>/= 130 and/or >/= 80 milligrams of mercury [mmHg]) or current use of anti-hypertensive medication, dyslipidemia (triglycerides >/= 150 milligrams/deciliter (mg/dL) and/or HDL cholesterol < 40 mg/dL or current use of cholesterol-lowering medication, diagnosis of obstructive sleep apnea
Key exclusion criteria (33 listed)
- Tanner stage 1-4
- Diabetes (1 or 2)
- Current or recent (< 6 months prior to enrollment) use of anti-obesity medication(s) and other weight-altering medication(s) (e.g.,, atypical antipsychotics, attention-deficit hyperactivity disorder [ADHD] stimulant)
- Previous bariatric surgery
- Current or recent (< 6 months prior to enrollment) use of medication(s) to treat insulin resistance
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 |
|---|---|---|
| Qsymia and lifestyle management therapyQsymia will be used at 3.7g mg/23 mg for 12 weeks and then increased to 7.5 mg/46 mg for the remainder of the study. Participants will be offered lifestyle management therapy. | Drug | Medication arm |
| Placebo and lifestyle management therapyPlacebo will be used in lieu of Qsymia to maintain the blind. Participants will be offered lifestyle management therapy. | Behavioural | Placebo arm |
Primary outcome
Evaluate effects of preventive pharmacotherapy and lifestyle-based weight gain prevention on body mass index between the medication arm and the placebo arm
Time frame: 24 months
Change in BMI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided. Deidentified data may be shared with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Qsymia and lifestyle management therapy in people with Obesity, Adolescent, run by University of Minnesota 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 33 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: withdrawn, as of the sponsor's last update on 26 Oct 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate effects of preventive pharmacotherapy and lifestyle-based weight gain prevention on body mass index between the medication arm and the placebo arm (time frame: 24 months). 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 26 Oct 2023.