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WithdrawnPhase 4

Treating Toddler Obesity by Treating the Parent/Caregiver Obesity With Weight Loss Medications

Key facts

Who runs it
Loma Linda University
Where
Loma Linda, United StatesSee the 2 sites
Trial code
Status
Withdrawn
Phase
Phase 4
Started
Dec 2025
Expected to end
Nov 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Lomaira 8Mg Tablet
Record updated
20 November 2025
Why it stopped
Difficult to recruit. an unexpected result is the easy availability of GLP 1 medication to the general public.

Who can take part

Age
12 months to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Self-identify as being of Hispanic/Latino or African American ethnicity
  • BMI ≥30 with a stable weight (no more than 5% variation during the previous 3 months) and an agreement not to initiate any other weight loss
  • HbAlc ≤ 6.4
  • Fluent in written and spoken English
  • Self-identify as being of Hispanic/Latino or African American ethnicity
  • BMI ≥ 95th percentile for age, gender and height
  • Age 12 to 36 months of age
  • Spends at least half of its awake time per day with the P/OCG who is the consenting adult and who provides at least half of the toddler's diet on that day

Who cannot take part

  • Have been treated with prescription drugs that promote weight loss (for example, liraglutide [Saxenda™], orlistat [Xenical®], phentermine Adipex®], phentermine/topiramate [Qsymia™], semaglutide 2.4 mg [Wegovy™], tirzepatide [Zepbound™], bupropion/naltrexone [Contrave™], phentermine [Lomaira™] or similar other weight loss medications including over-the-counter (OTC) medications (for example, Alli®). Use of obesogenic medications (including but not limited to steroids, haloperidol, clozapine, risperidone, olanzapine, amitriptyline, imipramine, paroxetine, and lithium) which cannot be substituted or stopped
  • Use of obesogenic medications (including but not limited to steroids, haloperidol, clozapine, risperidone, olanzapine, amitriptyline, imipramine, paroxetine, and lithium) which cannot be substituted or stopped
  • Current cancer treatment
  • History of drug or alcohol abuse
  • Current cancer treatment
  • Genetic disorders and/or physical or mental handicaps that would limit participation in the study and/or the lifestyle intervention
  • Unwilling to use accepted standards of birth control if female and before menopause age. (i.e. IUD, birth control pills/injections, tubal or vas deferens ligation) during the study and for 30 days after the study is completed. Condoms or rhythm methods are not sufficient
  • Nursing or planning to become pregnant in the next 10 months
  • Any special dietary or exercise requirements
  • Any established chromosome abnormalities that might be associated with obesity

Where in United States

  • Loma Linda UniversityLoma Linda, United StatesNo longer taking part
  • Nutrition Research CenterLoma Linda, United StatesNo longer taking part

About the trial

What the trial wants to find out

The purpose of this study is to treat toddler obesity by improving the toddler nutritional environment. Parents will participate in a free internet nutrition program and may also take obesity medication. These measures may improve the parental nutritional environment and in turn, improve the toddler nutritional environment as well.

The 2 groups in the trial

  • Active LomairaExisting treatment, for comparison

    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.

    Treatment: Lomaira 8Mg Tablet

  • PlaceboNo study treatment, for comparison

    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.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Parent Toddler Obesity Study (PTOS)
Record updated
20 November 2025