ObesityPhase 3LSSNCT05087342
Latino Semaglutide Study
A Phase 3 study testing Semaglutide 2.4mg in people with Obesity and Obesity; Drug, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study to understand better how this anti-obesity medication works to assist individuals to lose weight and maintain weight loss. This study may lead to the development of other related medications for assisting people with the disease of obesity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Obesity; Drug, Overweight or Obesity
- What is being tested?
- Semaglutide 2.4mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2022to 29 May 2024
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as being of Hispanic/Latino ethnicity
- BMI >30
- Age 18-75 years old
- Able to provide informed consent before any trial related activities
Who cannot join
- Current cancer treatment
- Diabetes, Type 1 or Type 2
- Eating disorders
- Medication use targeting the GPL-1 system
- In the last 30 days, attempted to lose weight by lifestyle modification alone or with the use of anti-obesity medications resulting in more than 5 pounds of weight loss.
- History of bariatric surgery
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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.
- Pregnant or planning to become pregnant in the next 8 months
- Genetic disorders and/or physical or mental handicaps that would limit participation in the study and/or the intensive lifestyle intervention.
- Any contraindication to semaglutide 2.4 mg including personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2, hypersensitivity to semaglutide 2.4 mg or any product components.
- Any known or suspected allergy to semaglutide 2.4 mg or related products
- Previous participation in this trial, either initial screening or group randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92350
About this study
Official title: A Randomized Latino Semaglutide 2.4mg Study
The purpose of this study to understand better how this anti-obesity medication works to assist individuals to lose weight and maintain weight loss. This study may lead to the development of other related medications for assisting people with the disease of obesity.
- Conditions
- Obesity, Obesity; Drug, Overweight or Obesity, Weight Loss, Weight Loss Trajectory, Weight, Body
- Being tested
- Semaglutide 2.4mg, Placebo
- Keywords
- obesity, obesity; drug, overweight, weight loss, weight
- Medical subject headings
- Obesity, Overweight, Weight Loss, Body-Weight Trajectory, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4mgDrug
The intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description.
PlaceboDrug
A placebo will be given to the control group per the schedule outlined in the armed description.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Will receive active medication semaglutide subcutaneously, once weekly, self-injection.
Month 1 - 0.24 mg SC once weekly x 4 weeks.(IE-1) Month 2- 0.5 mg SC once weekly x 4 weeks.(IE-2) Month 3 -1 mg SC once weekly x 4 weeks.(IE-3) Month 4 - 1.7 mg SC once weekly x 4 weeks.(IE-4) Month 5 - 2.4 mg SC once weekly x 4 weeks. (IE-5) Month 6 - 2.4 mg SC continue once weekly x 8 weeks.(IE-6) Month 7 - completion visit (IE-7) Receives: Drug: Semaglutide 2.4mg |
| Control Group | Placebo comparator | Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of weight loss.
Assessment will be based on pounds lost between baseline and final study visit.
Measured: Change between baseline and final study visit, seven months post baseline.
Secondary outcomes (1)
Food Addiction Assessment
Yale Food Addiction Scale Survey administered to subjects at baseline and month four of treatment. Assessment results based on multiple survey questions regarding intake of specific food types (sugar, starch, sweet, salty, savory).
Measured: Change between baseline and month four of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start13 Dec 2022
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Warren Peters, MD, MPH, Loma Linda University
- Investigators
- Warren Peters, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087342
- Sponsor's protocol ID
- 5210364
- Acronym
- LSS
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Latino Semaglutide 2.4mg Study
- ClinicalTrials.gov ID
- NCT05087342
- Acronym / sponsor ID
- LSS / 5210364
- Conditions
- Obesity, Obesity; Drug, Overweight or Obesity, Weight Loss, Weight Loss Trajectory, Weight, Body
- Keywords
- obesity, obesity; drug, overweight, weight loss, weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 21 Oct 2021 (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 to understand better how this anti-obesity medication works to assist individuals to lose weight and maintain weight loss. This study may lead to the development of other related medications for assisting people with the disease of obesity.
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 |
|---|---|---|
| Intervention Group | Active comparator | Drug: Semaglutide 2.4mgWill receive active medication semaglutide subcutaneously, once weekly, self-injection. Month 1 - 0.24 mg SC once weekly x 4 weeks.(IE-1) Month 2- 0.5 mg SC once weekly x 4 weeks.(IE-2) Month 3 -1 mg SC once weekly x 4 weeks.(IE-3) Month 4 - 1.7 mg SC once weekly x 4 weeks.(IE-4) Month 5 - 2.4 mg SC once weekly x 4 weeks. (IE-5) Month 6 - 2.4 mg SC continue once weekly x 8 weeks.(IE-6) Month 7 - completion visit (IE-7) |
| Control Group | Placebo comparator | Drug: PlaceboWill receive placebo, subcutaneously, once weekly, self-injection throughout study duration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as being of Hispanic/Latino ethnicity
- BMI >30
- Age 18-75 years old
- Able to provide informed consent before any trial related activities
Key exclusion criteria (12 listed)
- Current cancer treatment
- Diabetes, Type 1 or Type 2
- Eating disorders
- Medication use targeting the GPL-1 system
- In the last 30 days, attempted to lose weight by lifestyle modification alone or with the use of anti-obesity medications resulting in more than 5 pounds of weight loss.
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 |
|---|---|---|
| Semaglutide 2.4mgThe intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description. | Drug | Intervention Group |
| PlaceboA placebo will be given to the control group per the schedule outlined in the armed description. | Drug | Control Group |
Primary outcome
Assessment of weight loss.
Time frame: Change between baseline and final study visit, seven months post baseline.
Assessment will be based on pounds lost between baseline and final study visit.
1 secondary outcome
Food Addiction Assessment
Time frame: Change between baseline and month four of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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 Peters, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide 2.4mg in people with Obesity and Obesity; Drug, run by Loma Linda University at 1 site 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of weight loss. (time frame: Change between baseline and final study visit, seven months post baseline.). 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 15 Oct 2024.