Latino Semaglutide Study (LSS)

Loma Linda University (LLU)

Status and phase: Completed; Phase 3

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

Treatments: Drug: Semaglutide 2.4mg; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05087342

5210364

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 2 patient groups, including a placebo group

Intervention Group

Active Comparator group

Description:

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)

Treatment:

Drug: Semaglutide 2.4mg

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo