Latino Semaglutide Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2024-05-29

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Semaglutide 2.4mg

Intervention Type DRUG

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

Control Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Semaglutide 2.4mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No