Qsymia for Childhood Obesity

Overseen By Megan Bensignor, MD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must not be taking: Anti-obesity, Sulfonylureas, Stimulants, MAOIs

Disqualifiers: Pregnancy, Glaucoma, Psychiatric disorder, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not started or changed the dose of weight-altering medications in the past 6 months and excludes those currently using certain anti-obesity medications, sulfonylureas, stimulant medications, and others. If you are on these medications, you may need to stop them before participating.

What data supports the effectiveness of the drug Qsymia for childhood obesity?

Qsymia, a combination of phentermine and topiramate, has been approved in the US for managing obesity in children aged 12 and older. Studies show that this combination leads to more significant weight loss than using either drug alone, making it a promising option for treating pediatric obesity. ^{1 2 3 4 5}

Is Qsymia safe for treating childhood obesity?

Qsymia, a combination of phentermine and topiramate, has been approved for weight management in adolescents aged 12 and older. Known side effects include a slight increase in heart rate, mood and thinking changes, and metabolic acidosis (a condition where the body produces too much acid). ^{1 2 3 6 7}

How is the drug Qsymia different from other treatments for childhood obesity?

Qsymia is unique because it combines two drugs, phentermine and topiramate, to help reduce appetite and increase feelings of fullness, leading to greater weight loss than using either drug alone. It is one of the few medications approved for chronic weight management in adolescents, making it a novel option for treating childhood obesity. ^{1 2 3 6 8}

What is the purpose of this trial?

This trial tests a weight-loss pill called Phentermine/Topiramate in teenagers with type 2 diabetes and obesity. The pill helps reduce appetite and cravings, which can lead to weight loss and better diabetes control. The study aims to determine if this pill is more effective than other treatments. Phentermine/Topiramate has been shown to help with weight loss and managing type 2 diabetes in previous studies.

Research Team

Megan Bensignor, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adolescents aged 12-20 with type 2 diabetes and obesity (BMI ≥95th percentile). Participants must have a diagnosis of T2D with HgbA1c ≥6.5%, no diabetes auto-antibodies, and not be pregnant or planning pregnancy. They should agree to use two forms of contraception if applicable, speak English or Spanish, and not have certain medical conditions like severe kidney impairment or history of seizures.

Inclusion Criteria

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

My BMI is in the top 5% for my age and sex.

Negative diabetes auto-antibodies

Exclusion Criteria

I have been treated with growth hormone in the past.

I have used weight loss medication in the last 6 months.

I have a history of glaucoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo-Controlled Treatment

Participants are randomized to receive either phentermine/topiramate or placebo for 6 months

6 months

Monthly visits (in-person)

Open Label Extension

Participants receive open label phentermine/topiramate for an additional 6 months

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Phentermine/Topiramate

Trial Overview The study tests Phentermine/Topiramate (Qsymia), an FDA-approved adult obesity medication, against a placebo in adolescents. The drug has shown significant weight loss in adults over one year. This trial will assess its effectiveness and safety profile in the younger population with both obesity and type 2 diabetes.

Participant Groups

Group I: Open Label Extension Experimental Treatment 1 Intervention

Participants in this phase of the study will receive open label phentermine/topiramate.

Group II: Placebo-Controlled Period Placebo Group 2 Interventions

Participants in this phase of the study will be randomized 1:1 to receive either phentermine/topiramate or placebo.

Phentermine/Topiramate is already approved in United States for the following indications:

Approved in United States as Qsymia for:

• Obesity in adults with a BMI of 27 kg/m^2 or greater and at least one weight-related comorbidity, or with a BMI of at least 30 kg/m^2

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Qsymia™, a combination of phentermine and topiramate, has been shown to produce greater weight loss than either drug alone, making it an effective treatment for obesity since its approval in 2012.

While Qsymia™ is effective, it carries potential risks such as teratogenicity, increased heart rate, psychiatric and cognitive side effects, and metabolic acidosis, which are consistent with the known side effects of its individual components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of phentermine/topiramate (Qsymia™) combination for the treatment of obesity. Shin, JH., Gadde, KM.[2021]

Phentermine/topiramate (Qsymia®) is a combination medication approved in July 2022 for chronic weight management in pediatric patients aged 12 and older with obesity, specifically those with a BMI in the 95th percentile or greater.

This medication works by decreasing appetite and increasing feelings of fullness, and it is also being studied for other conditions like sleep apnea and type 2 diabetes in obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phentermine/Topiramate: Pediatric First Approval. Dhillon, S.[2022]

In a 56-week study involving adolescents aged 12 to under 17 with obesity, phentermine/topiramate (PHEN/TPM) significantly reduced body mass index (BMI) compared to placebo, with reductions of -10.44 percentage points for the top dose and -8.11 percentage points for the mid dose (both P<0.001).

PHEN/TPM also positively affected triglyceride and HDL cholesterol levels, although the incidence of adverse events was higher in the treatment groups (51.8% for placebo, 37.0% for mid-dose, and 52.2% for top-dose), indicating a need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phentermine/Topiramate for the Treatment of Adolescent Obesity. Kelly, AS., Bensignor, MO., Hsia, DS., et al.[2023]

Combination pharmacotherapy, such as using phentermine and topiramate together, may provide better weight loss results for pediatric patients with obesity compared to single-agent treatments, which often have limited efficacy.

This case report of a 10-year-old girl illustrates the potential benefits of combining medications after lifestyle modifications were insufficient, highlighting the need for more effective treatment options in pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Role of Combination Pharmacotherapy to Improve Outcomes of Pediatric Obesity: A Case Report and Discussion. Fox, CK., Kelly, AS.[2020]

The American Academy of Pediatrics now recognizes pediatric obesity as a chronic disease and supports the use of various treatment options, including lifestyle changes, medications, and surgery, to address this growing issue.

Phentermine/topiramate, a combination medication approved for youth aged 12 and older, has shown promise for chronic weight management in pediatric patients, although clinical trials for obesity treatments in children remain limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review: Phentermine and Topiramate for the Treatment of Pediatric Obesity. Kim, A., Nguyen, J., Babaei, M., et al.[2023]

Phentermine/topiramate controlled-release (PHEN/TPM CR) led to significant weight loss of 8.1-10.9% in patients, compared to only 1.4-1.8% in placebo groups, and also reduced waist circumference and improved metabolic markers like blood pressure and lipid profiles.

The treatment was generally well-tolerated, with severe adverse events being similar to those in placebo groups, although common side effects included paresthesia, dry mouth, and insomnia. Long-term safety and efficacy still need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the metabolic effects of controlled-release Phentermine/Topiramate. Kiortsis, DN.[2019]

In a study involving 42 adolescents aged 12 to 17 with obesity, the fixed-dose combination of phentermine and topiramate (VI-0521) led to significant weight loss, with 13.3% of the mid-dose group and 50.0% of the top-dose group achieving at least a 5% reduction in weight by day 56.

The combination was found to be safe and well-tolerated, with pharmacokinetic profiles similar to those observed in adults, suggesting that both mid- and top-dose levels are suitable for further long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity. Hsia, DS., Gosselin, NH., Williams, J., et al.[2022]

Qsymia™, a once-daily oral capsule combining phentermine and extended-release topiramate, has been approved in the US for treating obesity, leveraging phentermine's appetite-suppressing effects and topiramate's ability to increase feelings of fullness.

The formulation is also being explored for potential benefits in treating sleep apnea and type 2 diabetes, indicating its broader therapeutic applications beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phentermine and topiramate extended release (Qsymia™): first global approval. Cameron, F., Whiteside, G., McKeage, K.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical utility of phentermine/topiramate (Qsymia™) combination for the treatment of obesity. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Phentermine/Topiramate: Pediatric First Approval. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Phentermine/Topiramate for the Treatment of Adolescent Obesity. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential Role of Combination Pharmacotherapy to Improve Outcomes of Pediatric Obesity: A Case Report and Discussion. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Narrative Review: Phentermine and Topiramate for the Treatment of Pediatric Obesity. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A review of the metabolic effects of controlled-release Phentermine/Topiramate. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Phentermine and topiramate extended release (Qsymia™): first global approval. [2021]