Phentermine for Childhood Obesity
(PhITT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of phentermine, a medication for treating obesity in adolescents. Participants will receive either phentermine or a placebo (a pill with no active ingredients) for one year to assess its impact on weight loss. Researchers aim to determine if phentermine can effectively complement lifestyle changes in managing obesity. Adolescents aged 12 to under 18 with obesity, who have not recently used certain medications, may qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings in obesity management.
Is there any evidence suggesting that phentermine is likely to be safe for adolescents with obesity?
Studies have shown that phentermine is generally safe for children and teenagers. One report found no serious side effects when phentermine was used, with the most common issues being mild stomach problems, such as an upset stomach. Another study found that over 60% of young people taking phentermine lost more than 5% of their body weight after six months, with no major safety concerns.
Although specific research on children is limited, phentermine is already approved for weight management in older teens and adults. This approval indicates that the drug has passed safety checks for these age groups, which reassures its use in teenagers. However, as with any medication, individual reactions can vary, so healthcare providers should monitor its use.12345Why do researchers think this study treatment might be promising for obesity?
Most treatments for childhood obesity focus on lifestyle changes, like diet and exercise, or medications that alter appetite and fat absorption. But phentermine stands out because it acts as an appetite suppressant by stimulating the central nervous system, similar to how it affects adults with obesity. Researchers are excited about phentermine because it has the potential to provide a pharmacological option specifically tailored for adolescents, offering a new avenue beyond the traditional lifestyle modifications. If successful, it could be a game-changer for young individuals struggling with obesity, providing them with an effective tool to manage their weight more proactively.
What evidence suggests that phentermine might be an effective treatment for childhood obesity?
Research has shown that phentermine can help teenagers with obesity lose weight. One study found that 40% of participants taking phentermine lost more than 5% of their body weight in just three months, with over 60% reaching this goal by six months. Another study discovered that phentermine, often combined with other medications like topiramate, helped most patients lower their Body Mass Index (BMI, a measure of body fat based on height and weight) over 3 to 12 months. In this trial, participants in the Phentermine 16 mg Group will receive phentermine to evaluate its efficacy and safety in adolescents with obesity. These findings suggest that phentermine can effectively help young people manage obesity by promoting weight loss.23467
Who Is on the Research Team?
Russell McCulloh, MD
Principal Investigator
UNMC
Are You a Good Fit for This Trial?
This trial is for teens aged 12 to under 18 who have obesity (BMI at or above the 95th percentile for their age and sex, or BMI of at least 30). Participants must be in puberty (Tanner stage 2 or higher), and girls must use reliable birth control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive phentermine or placebo daily for 52 weeks
Withdrawal Assessment
Participants undergo a 2-week withdrawal assessment to monitor for withdrawal symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Phentermine
Trial Overview
The study compares a daily dose of phentermine (16 mg) with a placebo over one year. Teens are randomly assigned to either group without knowing which they receive. The goal is to see if phentermine helps with weight loss and is safe.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants in this arm will receive phentermine 16 mg daily, administered as two 8 mg tablets taken orally once
Participants in this arm will receive placebo tablets that are visually identical to the phentermine tablets but contain no active pharmaceutical ingredient. The placebo will be taken orally once daily in the morning for 52 weeks. All participants will also receive lifestyle education handouts at each study visit. This arm serves as the control group for evaluating the efficacy and safety of phentermine in adolescents with obesity.
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Who Is Running the Clinical Trial?
Russell McCulloh, MD
Lead Sponsor
IDeA States Pediatric Clinical Trials Network
Collaborator
National Institutes of Health (NIH)
Collaborator
Citations
Real-World Use of Phentermine and Topiramate for ... - PubMed
Phentermine and/or topiramate resulted in BMI reduction in most patients exposed for 3-12 months. Safety data support individualized monitoring
pfm :: Precision and Future Medicine
Efficacy data. Thus far, two trials of phentermine-topiramate combination therapy have been conducted in children and adolescents with obesity.
Pharmacotherapy for Pediatric Obesity: A Phentermine ...
This is a multi-site, randomized, placebo-controlled clinical trial to examine the weight loss efficacy and cardiovascular safety of phentermine 15 mg daily ...
Phentermine/Topiramate for the Treatment of Adolescent ...
PHEN/TPM at both the mid and top doses offered a statistically significant reduction in BMI and favorably impacted triglyceride and HDL-C levels ...
A systematic review and network meta-analysis | PLOS One
The study found that semaglutide outperformed other AOMs in reducing BMI and additional weight-related outcomes in children and adolescents ...
Real-World Experience of the Efficacy and Safety of ... - PMC
Phentermine may be prescribed as a safe and effective means to achieve significant sustainable weight loss in children and adolescents when combined with ...
Real-World Use of Phentermine and Topiramate for ...
Phentermine and/or topiramate resulted in BMI reduction in most patients exposed for 3–12 months. Safety data support individualized monitoring ...
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