Latino Semaglutide Study

NCT05087342 — Phase 3, Completed, 119 participants, Loma Linda University

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A Randomized Latino Semaglutide 2.4mg Study

Registry	NCT05087342, acronym LSS
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	119 (Actual)
Sponsor	Loma Linda University (Other); collaborators: Novo Nordisk A/S
Conditions	Obesity, Obesity; Drug, Overweight or Obesity, Weight Loss, Weight Loss Trajectory, Weight, Body
Interventions	Semaglutide 2.4mg, Placebo (Drug)
Dates	start 2022-12-13, primary completion 2024-05-29, completion 2024-05-29, first posted 2021-10-21, last updated 2024-10-15
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention Group	Active comparator	Drug: 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)
Control Group	Placebo comparator	Drug: Placebo	Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration.

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.

+Outcome measures

Primary outcomes

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 outcomes

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).

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Loma Linda University Health	Loma Linda, California	United States

+Investigators

Warren Peters, MD, Principal investigator, Loma Linda University