Latino Semaglutide Study

Obesity Clinical Trial

— LSS  

Official title:

A Randomized Latino Semaglutide 2.4mg Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05087342
• Other study ID #: 5210364
• Status: Recruiting
• Phase: Phase 3
• Start date: December 13, 2022
• Est. completion date: May 2024

Study information

• Verified date: June 2023
• Source: Loma Linda University
• Contact: Warren Peters, MD
• Phone: (909) 558-0182
• Email: wpeters[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Obesity; Drug
• Overweight
• Overweight or Obesity
• Weight Loss
• Weight, Body

Intervention

Drug:
• Semaglutide 2.4mg
The intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description.
• Placebo
A placebo will be given to the control group per the schedule outlined in the armed description.

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.