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

NCT06768320 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB 5240207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Weight Loss; Obesity, Childhood; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Toddler's Body Mass index (BMI) percentile at week 37

  Toddler BMI will be measured at enrollment and at final study visit week 37. BMI will be calculated using the InBody Scale. This is a composite measurement consisting of height and weight.

  Change between baseline visit and final study visit at week 37

• Change in parent's Body Mass index (BMI) at week 37

  Adults BMI will be measured at enrollment and at final study visit week 37. BMI will be calculated using the InBody Scale. This is a composite measurement consisting of height and weight.

  Change between baseline visit and final study visit at week 37

Study Arms (2)

Active Lomaira

ACTIVE COMPARATOR

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.

Drug: Lomaira 8Mg Tablet

Placebo

NO 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.

Interventions

Lomaira 8Mg Tablet DRUG

8 mg tablet up to three times a day

Active Lomaira

Eligibility Criteria

• Age: 12 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current cancer treatment
• 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
• History of drug or alcohol abuse
• Nursing or planning to become pregnant in the next 10 months
• 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.
• 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
• Current cancer treatment
• 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
• Genetic disorders and/or physical or mental handicaps that would limit participation in the study and/or the lifestyle intervention
• Any special dietary or exercise requirements
• Any established chromosome abnormalities that might be associated with obesity

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Nutrition Research Center

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Weight Loss; Pediatric Obesity; Obesity

Interventions

Phentermine; Tablets

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Warren C Peters, MD

  Loma Linda University (School of Public Health)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)