Obesity, Obesity; Drug, Overweight or Obesity, Weight Loss, Weight Loss Trajectory, Weight, Body
Conditions
Keywords
obesity, obesity; drug, overweight, weight loss, weight
Brief 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.
Interventions
The intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description.
DRUGPlacebo
A placebo will be given to the control group per the schedule outlined in the armed description.
Sponsors
Novo Nordisk A/S
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of weight loss. | Change between baseline and final study visit, seven months post baseline. | Assessment will be based on pounds lost between baseline and final study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Addiction Assessment | Change between baseline and month four of treatment. | 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). |
Countries
United States
Outcome results
None listed