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Completed

NCT Number: NCT05087342

Latino Semaglutide 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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Body-Weight Trajectory Nutrition Disorders Nutritional and Metabolic Diseases Obesity; Drug Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss Weight Loss Trajectory Weight, Body

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Loma Linda University Health

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Assessment of weight loss.

    Time frame: 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 outcomes

  1. Food Addiction Assessment

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

A Randomized Latino Semaglutide 2.4mg Study

Acronym: LSS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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