Lomaira for Childhood Obesity

(PTOS Trial)

No longer recruiting at 1 trial location

Overseen By Warren Peters, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Loma Linda University

Must not be taking: Weight loss drugs, Obesogenic drugs

Disqualifiers: Cancer treatment, Drug abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 37 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to assist toddlers with obesity by enhancing their nutritional environment. Parents will participate in a free online nutrition program and may also use the medication Lomaira, known to aid weight loss. The study aims to determine if these measures can foster a healthier lifestyle for both parents and their toddlers. Adults who are Hispanic/Latino or African American with a BMI of 30 or more, and toddlers in the 95th percentile or above for weight, may be suitable candidates. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking any prescription or over-the-counter weight loss medications and any obesogenic medications (medications that can cause weight gain) that cannot be substituted or stopped.

What is the safety track record for Lomaira?

Research shows that using Lomaira (phentermine) for weight loss in children remains under exploration. Some studies suggest it can be effective and safe when combined with lifestyle changes. In one study, 70% of children lost weight using this method.

However, Lomaira is not officially approved for children under 17, leaving its safety and effectiveness for them uncertain. Some experts advise caution because the long-term effects and optimal dosage for children are not yet clear.

While Lomaira is used for adults, more research is needed to understand how well children can tolerate it. Always consult a healthcare provider before considering any treatment for a child. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for childhood obesity, Lomaira is a low-dose formulation of phentermine that offers a unique dosing schedule. Most current obesity treatments rely on lifestyle changes or surgical options, but Lomaira is taken one tablet per day, 30 minutes before a meal, and includes scheduled breaks, which could help manage tolerance and maintain effectiveness. Researchers are excited because this approach may provide a more sustainable and manageable option for young patients, potentially reducing risks associated with long-term medication use.

What is the effectiveness track record for Lomaira in treating childhood obesity?

Research has shown that Lomaira, which contains phentermine, can aid in weight loss. Studies with adults have demonstrated that phentermine effectively lowers body mass index (BMI), a measure of body fat based on height and weight. One study found that most adults using phentermine experienced a decrease in BMI over 3 to 12 months. In this trial, participants will receive either Lomaira or a placebo to evaluate its effectiveness for childhood obesity. Although Lomaira is newer for children, its success in adults suggests it might also help with childhood obesity. Phentermine reduces appetite, supporting weight loss. This treatment has been used safely in weight management programs when combined with healthy eating and exercise. ^{4 6 7 8 9}

Who Is on the Research Team?

Warren C Peters, MD

Principal Investigator

Loma Linda University (School of Public Health)

Are You a Good Fit for This Trial?

This trial is for parents or caregivers of toddlers who are dealing with obesity. Participants should be interested in improving their own and their toddler's nutritional environment through an online nutrition program. Some will also take a weight loss medication called Lomaira.

Inclusion Criteria

Adults self-identifying as Hispanic/Latino or African American ethnicity

Toddlers self-identifying as Hispanic/Latino or African American ethnicity

My child is between 1 and 3 years old.

Exclusion Criteria

My toddler is on medication that may cause weight gain and cannot be stopped.

Adults with a history of drug or alcohol abuse

I am currently receiving treatment for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents or caregivers are randomized to receive either an obesity drug or a placebo, while participating in the Full Plate Living lifestyle program

37 weeks

Regular visits for lab results, biometric measurements, and nutrition questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lomaira

Trial Overview

The study is testing whether parents taking the Lomaira 8Mg Tablet, along with participating in a free internet nutrition program, can positively influence their toddler's nutritional environment and potentially reduce toddler obesity.

How Is the Trial Designed?

Group I: Active Lomaira Active Control 1 Intervention

Participants will receive Lomaira 8mg for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal.

Group II: Placebo Active Control 1 Intervention

Participants will receive Placebo for 12 weeks and off 12 weeks, will restart at week 24 for 12 weeks one tablet per day 30 minutes before a meal.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

Recent advancements in anti-obesity medications (AOMs), particularly glucagon-like peptide 1 receptor agonists and phentermine-topiramate, have shown promising safety and efficacy in treating pediatric obesity, as highlighted by clinical trials since 2020.

A comprehensive treatment approach that combines lifestyle modifications with ongoing pharmacotherapy is essential for improving long-term health outcomes in children and adolescents with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future pharmacotherapies for obesity in children and adolescents. Kelly, AS.[2023]

Children with obesity often do not have appropriate drug dosing guidelines, leading to increased risks of adverse events and challenges for healthcare providers in managing their care.

The study emphasizes the need for well-designed pharmacokinetic (PK) trials and collaboration with the FDA to improve drug labeling and dosing information for this vulnerable population, which could significantly enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. Zimmerman, KO., Benjamin, DK., Becker, ML., et al.[2023]

In a study of 6454 children and adolescents with obesity, participation in pediatric weight management programs led to a modest median decrease in body mass index (BMI), with significant improvements observed over 12 months.

Factors such as older age (≥12 years), greater severity of obesity, and Hispanic ethnicity were linked to better outcomes in BMI reduction, which also correlated with improvements in cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. Kumar, S., King, EC., Christison, AL., et al.[2020]

Citations

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Lomaira for Childhood Obesity (PTOS Trial)

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NCT05176626 | Long-term Effectiveness of the Antiobesity ...

The purpose of this research study is to understand the long-term effects of the drug phentermine on weight, blood pressure, other health outcomes, and safety.

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Real-World Use of Phentermine and Topiramate for ...

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Obesity in Children Medication: Anorexiants, Adrenergic ...

Anorexiants are administered to manage obesity. Indications include weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet.

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sciencedirect.com/science/article/pii/S2667368122000158

Obesity pillars roundtable: Phentermine – Past, present, ...

My clinical impression was that sibutramine was relative effective and safe in promoting clinically meaningful weight reduction among my patients with obesity.

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fda.gov/media/138795/download

LOMAIRA™ (phentermine hydrochloride USP) tablets, CIV

Pediatric Use. Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term ...

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pmc.ncbi.nlm.nih.gov/articles/PMC10698794/

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Phentermine monotherapy is an effective and safe means for weight loss in pediatric patients when combined with lifestyle interventions. Twenty-one of 30 (70%) ...

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Lomaira (Phentermine): Uses, Side Effects, Dosage & More

Lomaira (phentermine) is a prescription appetite suppressant. It's used to help with weight loss and is approved for people ages 17 years and older.