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Latino Semaglutide Study (LSS)

Primary Purpose

Obesity, Obesity; Drug, Overweight or Obesity

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Semaglutide 2.4mg

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, obesity; drug, overweight, weight loss, weight

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Loma Linda University HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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)

Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration.

Outcomes

Primary Outcome Measures

Assessment of weight loss.

Assessment will be based on pounds lost between baseline and final study visit.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT05087342

First Posted

September 20, 2021

Last Updated

June 7, 2023

Sponsor

Loma Linda University

Collaborators

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT05087342

Brief Title

Latino Semaglutide Study

Acronym

LSS

Official Title

A Randomized Latino Semaglutide 2.4mg Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 13, 2022 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Loma Linda University

Collaborators

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

obesity, obesity; drug, overweight, weight loss, weight

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Active Comparator

Arm Description

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration.

Intervention Type

Drug

Intervention Name(s)

Semaglutide 2.4mg

Intervention Description

The intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

A placebo will be given to the control group per the schedule outlined in the armed description.

Primary Outcome Measure Information:

Title

Assessment of weight loss.

Description

Assessment will be based on pounds lost between baseline and final study visit.

Time Frame

Change between baseline and final study visit, seven months post baseline.

Secondary Outcome Measure Information:

Title

Food Addiction Assessment

Description

Time Frame

Change between baseline and month four of treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Warren Peters, MD

Phone

(909) 558-0182

wpeters@llu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Amandeep Kaur, MPH

Phone

(909) 558-0182

akaur1@llu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Warren Peters, MD

Organizational Affiliation

Loma Linda University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loma Linda University Health

City

Loma Linda

State/Province

California

ZIP/Postal Code

92350

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Warren Peters, MD

Phone

909-558-0182

wpeters@Llu.edu

First Name & Middle Initial & Last Name & Degree

Amandeep Kaur, BS

Phone

909-558-0182

akaur1@llu.edu

12. IPD Sharing Statement

Learn more about this trial

Latino Semaglutide Study

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