Latino Semaglutide Study

NCT05087342 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 5210364
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Food Addiction Assessment

  Change between baseline and month four of treatment.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Semaglutide 2.4mg DRUG

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

Intervention Group

Placebo DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Body-Weight Trajectory; Body Weight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Warren Peters, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Center for Health Promotion, Loma Linda University and Associate Professor, School of Medicine, Loma Linda University

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 21, 2021
• Study Start: December 13, 2022
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)