Latino Semaglutide Study (LSS)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Loss; Overweight or Obesity; Weight, Body; Obesity; Drug; Weight Loss Trajectory
• Intervention / Treatment: Drug: Semaglutide 2.4mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Warren Peters, MD; Phone Number: (909) 558-0182; Email: wpeters@llu.edu
• Study Contact Backup: Name: Amandeep Kaur, MPH; Phone Number: (909) 558-0182; Email: akaur1@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Recruiting
      • Loma Linda University Health
      • Contact: Warren Peters, MD; Phone Number: 909-558-0182; Email: wpeters@Llu.edu
      • Contact: Amandeep Kaur, BS; Phone Number: 909-558-0182; Email: akaur1@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Warren Peters, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: obesity; overweight; weight loss; obesity; drug; weight
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight Changes; Obesity; Weight Loss; Overweight; Body Weight; Body-Weight Trajectory
• Other Study ID Numbers: 5210364

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes