Weight LossPhase 4PTOSNCT06768320
Treating Toddler Obesity by Treating the Parent/Caregiver Obesity With Weight Loss Medications
A Phase 4 study testing Lomaira 8Mg Tablet in people with Weight Loss and Obesity, Childhood, run by Loma Linda University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 75 years
- Conditions the study is for
- Weight Loss, Obesity, Childhood, Obesity
- What is being tested?
- Lomaira 8Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2025to Nov 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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.
- Current cancer treatment
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University
Loma Linda, California, 92350
Nutrition Research Center
Loma Linda, California, 92350
About this study
Official title: Parent Toddler Obesity Study (PTOS)
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.
Read the detailed description
Fifty parent or caregiver and toddler teams will be enrolled in a 37 week study in which the parents or caregivers will be randomized to receive either an obesity drug or a placebo, while simultaneously enrolled in the Full Plate Living lifestyle program. Study eligibility and ongoing participation will be assessed by lab results, biometric measurements and nutrition questionnaires to monitor the impact of diet and medication on the parental dietary environment. Toddler body mass index (BMI) will be calculated at study inception and completion to assess potential impact on the toddler dietary environment. Teaching will be provided to parents on healthy dietary choices, adequate sleep and stress control.
- Conditions
- Weight Loss, Obesity, Childhood, Obesity
- Being tested
- Lomaira 8Mg Tablet
- Medical subject headings
- Weight Loss, Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lomaira 8Mg TabletDrug
8 mg tablet up to three times a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change between baseline visit and final study visit at week 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study startDec 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionNov 2027 (estimated)
Why it stopped: Difficult to recruit. an unexpected result is the easy availability of GLP 1 medication to the general public.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren C Peters, MD, Principal investigator, Loma Linda University (School of Public Health)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768320
- Sponsor's protocol ID
- IRB 5240207
- Acronym
- PTOS
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No formal plans
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Toddler Obesity Study (PTOS)
- ClinicalTrials.gov ID
- NCT06768320
- Acronym / sponsor ID
- PTOS / IRB 5240207
- Conditions
- Weight Loss, Obesity, Childhood, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult to recruit. an unexpected result is the easy availability of GLP 1 medication to the general public.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fifty parent or caregiver and toddler teams will be enrolled in a 37 week study in which the parents or caregivers will be randomized to receive either an obesity drug or a placebo, while simultaneously enrolled in the Full Plate Living lifestyle program. Study eligibility and ongoing participation will be assessed by lab results, biometric measurements and nutrition questionnaires to monitor the impact of diet and medication on the parental dietary environment. Toddler body mass index (BMI) will be calculated at study inception and completion to assess potential impact on the toddler dietary environment. Teaching will be provided to parents on healthy dietary choices, adequate sleep and stress control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Lomaira | Active comparator | Drug: Lomaira 8Mg TabletParticipants 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. |
| 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. |
Who may qualify
- Ages
- 12 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lomaira 8Mg Tablet8 mg tablet up to three times a day | Drug | Active Lomaira |
Primary outcome
Change in Toddler's Body Mass index (BMI) percentile at week 37
Time frame: Change between baseline visit and final study visit 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 in parent's Body Mass index (BMI) at week 37
Time frame: Change between baseline visit and final study visit 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. No formal plans
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren C Peters, MD principal investigator
Loma Linda University (School of Public Health)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lomaira 8Mg Tablet in people with Weight Loss and Obesity, Childhood, run by Loma Linda University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Toddler's Body Mass index (BMI) percentile at week 37 (time frame: Change between baseline visit and final study visit at week 37). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.