Latino Semaglutide Study

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Latino Semaglutide 2.4mg Study

Conditions
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Obesity, Obesity; Drug, Overweight or Obesity, Weight Loss, Weight Loss Trajectory, Weight, Body

Intervention / Treatment
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* Drug: Semaglutide 2.4mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>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) | Drug: Semaglutide 2.4mg<br>* The intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description.<br>|
| Placebo Comparator: Control Group<br>Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration. | Drug: Placebo<br>* A placebo will be given to the control group per the schedule outlined in the armed description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of weight loss. | Assessment will be based on pounds lost between baseline and final study visit. | Change between baseline and final study visit, seven months post baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change between baseline and month four of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, obesity; drug, overweight, weight loss, weight