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CompletedNCT05087342LSSUpdated Oct 15, 2024

Latino Semaglutide Study

A Phase 3 interventional study of Semaglutide 2.4mg and Placebo in Obesity, Obesity; Drug and Overweight or Obesity, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Loma Linda University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2024, 2 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • obesity
  • obesity; drug
  • overweight
  • weight loss
  • weight
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 119 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Loma Linda University is the lead sponsor of 305 studies on the registry; 48 are open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
119 participants (actual)

Study arms

  • Active comparator
    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)

    Drug: Semaglutide 2.4mg

  • Placebo comparator
    Control Group

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

    Drug: Placebo

Interventions

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Assessment of weight loss.

    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 outcomes

  1. 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).

    Time frame: Change between baseline and month four of treatment.

07

Study locations

1 site
  • Loma Linda University Health
    Loma Linda, California 92350, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05087342
Collaborators
Novo Nordisk A/S
Responsible party
Warren Peters, MD, MPH (Medical Director, Center for Health Promotion, Loma Linda University and Associate Professor, School of Medicine, Loma Linda University, Loma Linda University) — Principal investigator
First posted
Oct 21, 2021
Start date
Dec 13, 2022
Primary completion
May 29, 2024
Completion
May 29, 2024
Last update
Oct 15, 2024

Study contacts

Warren Peters, MD
principal investigator · Loma Linda University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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