Pediatric ObesityEarly Phase 1NCT04881799
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
A Early Phase 1 study testing Phentermine/Topiramate (Qsymia) in people with Pediatric Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
As the prevalence of obesity rises in the U.S., so does the incidence of pediatric type 2 diabetes (T2D), which is associated with more aggressive disease progression than in adults. From 2002-2012, the incidence of T2D in youth increased by 7% annually in the U.S. Compared to adults. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Phentermine/Topiramate (Qsymia)
- 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
- 7 Jul 2022to 27 Oct 2026
- Phase
- Early Phase 1
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 12 to </= 20 years at study entry
- Obesity (BMI >/= the 95th percentile for age and sex)
- HgbA1c >/= 6.5% at type 2 diabetes diagnosis
- Negative diabetes auto-antibodies
- English-speaking and Spanish speaking
- For participants of child-bearing potential: when sexually active, agreement to use two forms of highly effective contraception (oral contraceptive pill, IUD, implant, and/or condoms) during study participation
Who cannot join
- Pregnancy or lactation
- Newly-initiated or change in dose of weight altering medication within past 6 months, including SGLT-2 inhibitors and DPP-IV inhibitors, liraglutide 1.8 mg and exenatide ER.
- Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination PHN/TPM, semaglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
- Current use of sulfonylureas
- Previous metabolic/bariatric surgery
- Current use of a stimulant medication
Show all 31Show fewer
- History of glaucoma
- Current or recent (< 14 days) use of monoamine oxidase inhibitor or carbonic anhydrase inhibitors
- Known hypersensitivity to sympathomimetic amines
- Any history of treatment with growth hormone
- any history of bulimia nervosa
- Major psychiatric disorder as determined by the local medical monitor
- Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression or PHQ-9 score of >/= 15
- Any history of active suicide attempt, a "yes" answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) on the "Suicidal Ideation" portion of the C-SSR, or a "yes" to answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS
- History of suicidal ideation or self-harm within the previous 30 days or a "yes" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the C-SSRS and the ideation or behavior occurred within the past month.
- Current pregnancy or plans to become pregnant during study participation
- Current tobacco use
- ALT or AST >/= 3 times the upper limit of normal
- Moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15)
- Bicarbonate <18 mmol/L
- Moderate (creatinine clearance [CrCl] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment
- Any history of seizures
- BP for ages 13 and older of > 130/80 on 3 separate measurements and for age 12 > 95th percentile on 3 separate measurements
- HR ≥120 bpm on 3 separate measurements
- History of structural heart defect or clinically significant arrhythmia
- Diagnosed monogenic obesity
- Any history of cholelithiasis
- Any history of nephrolithiasis
- Clinically diagnosed hyperthyroidism
- Untreated thyroid disorder or TSH below the lower laboratory limit of normal
- Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion may put the participant at risk
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
As the prevalence of obesity rises in the U.S., so does the incidence of pediatric type 2 diabetes (T2D), which is associated with more aggressive disease progression than in adults. From 2002-2012, the incidence of T2D in youth increased by 7% annually in the U.S. Compared to adults. T2D in adolescents is a much more progressive and recalcitrant disease, characterized by more rapid deterioration of β-cell function and earlier incidence of exogenous insulin dependence and diabetes-related comorbidities. A potential factor that drives the rapid progression of adolescent T2D is obesity (body mass index [BMI] >95th percentile. Effective and safe treatments targeting both obesity and β-cell dysfunction are needed for pediatric T2D.
In 2012, the FDA approved the use of Phentermine/Topiramate for the treatment of obesity in adults. This orally-administered medication is available in mid- (phentermine 7.5 mg; topiramate 46 mg) and high- (phentermine 15 mg; topiramate 92 mg) doses, administered once per day. In a meta-analysis, phentermine/topiramate was shown to be one of the most effective obesity medication currently available. A large dose-ranging trial in adults evaluating phentermine and topiramate as monotherapies vs. phentermine/topiramate demonstrated superior efficacy of the combination with an acceptable safety profile.
Results from a large phase III clinical trial demonstrated placebo-subtracted weight loss of >9% with treatment for one year at the top dose. Importantly, a separate trial demonstrated that the treatment effect is durable out to at least two years.41 The most common side effects in these trials were paresthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Improvements were noted in blood pressure, lipids, glucose, insulin, HOMA-IR, C-reactive protein, and adiponectin.
Read the detailed description
This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open-label extension, investigating the effects of phentermine/topiramate on BMI, insulin sensitivity, and glycemic control compared to placebo plus standard treatment (metformin+insulin) in adolescents with T2D. The purpose of this study is to 1) evaluate the effects of phentermine/topiramate vs. placebo+ standard treatment on BMI in adolescents with T2D and obesity and 2) evaluate the effects of phentermine/topiramate vs. placebo + standard treatment on insulin sensitivity and B-cell function in adolescents with T2D and obesity.
- Conditions
- Pediatric Obesity
- Being tested
- Phentermine/Topiramate (Qsymia), Placebo
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentermine/Topiramate (Qsymia)Drug
Oral pill taken once in the morning. Treatment will initiate with 3.75 mg/23 mg for 14 days, then increased to 7.5 mg/46 mg for 14 days, then increased to 11.25 mg/69 mg for 14 days then increased to the final dose of 15 mg/92 mg.
PlaceboDrug
Matching placebo taken orally once in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Placebo -> Qsymia | Placebo comparator | Participants randomized to placebo during the blinded treatment period who subsequently received study drug during the open-label extension. Receives: Drug: Phentermine/Topiramate (Qsymia); Drug: Placebo |
| Qsymia -> Qsymia | Experimental | Participants randomized to study drug during the blinded treatment period who continued receiving study drug during the open-label extension. Receives: Drug: Phentermine/Topiramate (Qsymia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index
The percent change in body mass index (BMI) from Baseline to Month 6 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters. The Phase 1 (double-blind) portion of the study was six months and data were collected at the end of the 6 month double-blind phase.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start7 Jul 2022
- Primary completion27 Oct 2025
- Study completion27 Oct 2026 (estimated)
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 Pediatric ObesityStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open label extension investigating the effects of phentermine/topiramate on BMI, insulin sensitivity, and glycemic control compared to placebo plus standard treatment (metformin + insulin) in adolescents with T2D. Individuals, when randomized to phentermine/topiramate therapy will initiate treatment at 3.75 mg/23 mg orally once daily in the morning for 14 days. It will then be increased to 7.5 mg/46 mg orally once daily in the morning for 14 days. It will the be increased to 11.25 mg/69 mg orally once daily in the morning for 14 days and finally to 15 mg/92 mg orally once daily in the morning.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Bensignor, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881799
- Sponsor's protocol ID
- PEDS-2021-29785
- Status last verified
- Apr 2026
- First submitted
- 5 May 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol, statistical analysis plan and final study report will be released to other researchers but will not contain identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
- ClinicalTrials.gov ID
- NCT04881799
- Acronym / sponsor ID
- PEDS-2021-29785
- Conditions
- Pediatric Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the prevalence of obesity rises in the U.S., so does the incidence of pediatric type 2 diabetes (T2D), which is associated with more aggressive disease progression than in adults. From 2002-2012, the incidence of T2D in youth increased by 7% annually in the U.S. Compared to adults. T2D in adolescents is a much more progressive and recalcitrant disease, characterized by more rapid deterioration of β-cell function and earlier incidence of exogenous insulin dependence and diabetes-related comorbidities. A potential factor that drives the rapid progression of adolescent T2D is obesity (body mass index [BMI] >95th percentile. Effective and safe treatments targeting both obesity and β-cell dysfunction are needed for pediatric T2D.
In 2012, the FDA approved the use of Phentermine/Topiramate for the treatment of obesity in adults. This orally-administered medication is available in mid- (phentermine 7.5 mg; topiramate 46 mg) and high- (phentermine 15 mg; topiramate 92 mg) doses, administered once per day. In a meta-analysis, phentermine/topiramate was shown to be one of the most effective obesity medication currently available. A large dose-ranging trial in adults evaluating phentermine and topiramate as monotherapies vs. phentermine/topiramate demonstrated superior efficacy of the combination with an acceptable safety profile.
Results from a large phase III clinical trial demonstrated placebo-subtracted weight loss of >9% with treatment for one year at the top dose. Importantly, a separate trial demonstrated that the treatment effect is durable out to at least two years.41 The most common side effects in these trials were paresthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Improvements were noted in blood pressure, lipids, glucose, insulin, HOMA-IR, C-reactive protein, and adiponectin.
Detailed description
This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open-label extension, investigating the effects of phentermine/topiramate on BMI, insulin sensitivity, and glycemic control compared to placebo plus standard treatment (metformin+insulin) in adolescents with T2D. The purpose of this study is to 1) evaluate the effects of phentermine/topiramate vs. placebo+ standard treatment on BMI in adolescents with T2D and obesity and 2) evaluate the effects of phentermine/topiramate vs. placebo + standard treatment on insulin sensitivity and B-cell function in adolescents with T2D and obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pilot, pragmatic, randomized trial with a 6-month placebo-controlled period followed by a 6-month open label extension investigating the effects of phentermine/topiramate on BMI, insulin sensitivity, and glycemic control compared to placebo plus standard treatment (metformin + insulin) in adolescents with T2D. Individuals, when randomized to phentermine/topiramate therapy will initiate treatment at 3.75 mg/23 mg orally once daily in the morning for 14 days. It will then be increased to 7.5 mg/46 mg orally once daily in the morning for 14 days. It will the be increased to 11.25 mg/69 mg orally once daily in the morning for 14 days and finally to 15 mg/92 mg orally once daily in the morning.
| Arm | Type | Receives |
|---|---|---|
| Placebo -> Qsymia | Placebo comparator | Drug: Phentermine/Topiramate (Qsymia), Drug: PlaceboParticipants randomized to placebo during the blinded treatment period who subsequently received study drug during the open-label extension. |
| Qsymia -> Qsymia | Experimental | Drug: Phentermine/Topiramate (Qsymia)Participants randomized to study drug during the blinded treatment period who continued receiving study drug during the open-label extension. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Ages 12 to </= 20 years at study entry
- Obesity (BMI >/= the 95th percentile for age and sex)
- HgbA1c >/= 6.5% at type 2 diabetes diagnosis
- Negative diabetes auto-antibodies
- English-speaking and Spanish speaking
Key exclusion criteria (31 listed)
- Pregnancy or lactation
- Newly-initiated or change in dose of weight altering medication within past 6 months, including SGLT-2 inhibitors and DPP-IV inhibitors, liraglutide 1.8 mg and exenatide ER.
- Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination PHN/TPM, semaglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
- Current use of sulfonylureas
- Previous metabolic/bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phentermine/Topiramate (Qsymia)Oral pill taken once in the morning. Treatment will initiate with 3.75 mg/23 mg for 14 days, then increased to 7.5 mg/46 mg for 14 days, then increased to 11.25 mg/69 mg for 14 days then increased to the final dose of 15 mg/92 mg. | Drug | Placebo -> Qsymia, Qsymia -> Qsymia |
| PlaceboMatching placebo taken orally once in the morning. | Drug | Placebo -> Qsymia |
Primary outcome
Change in Body Mass Index
Time frame: 6 Months
The percent change in body mass index (BMI) from Baseline to Month 6 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters. The Phase 1 (double-blind) portion of the study was six months and data were collected at the end of the 6 month double-blind phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The protocol, statistical analysis plan and final study report will be released to other researchers but will not contain identifying information.
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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.
Megan Bensignor, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Phentermine/Topiramate (Qsymia) in people with Pediatric Obesity, 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 6 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 22 May 2026). 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?
Change in Body Mass Index (time frame: 6 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 22 May 2026.