Latino Semaglutide Study

Phase 3

Completed

• Conditions: Obesity; Obesity; Drug; Weight Loss; Weight Loss Trajectory; Overweight or Obesity; Weight, Body
• Interventions: Drug: Placebo; Drug: Semaglutide 2.4mg

• Registration Number: NCT05087342
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Study Start: 2022-12-13
• Primary Completion: 2024-05-29
• Study Completion: 2024-05-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration.
Intervention Group	Semaglutide 2.4mg	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States