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Glucagon-like peptide-1 receptor agonist

Semaglutide for Obesity (LSS Trial)

Phase 3
Recruiting
Led By Warren Peters, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-75 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and month four of treatment.
Awards & highlights

LSS Trial Summary

This trial is testing an anti-obesity medication to see how well it works in helping people lose weight and keep it off. The results could help lead to new medications for obesity.

Who is the study for?
This trial is for Hispanic/Latino individuals aged 18-75 with obesity (BMI >30). Participants must be able to consent and not have current cancer, eating disorders, history of bariatric surgery, genetic issues affecting study participation, allergies to semaglutide or related drugs, recent significant weight loss attempts, contraindications to semaglutide including certain thyroid cancers or syndromes, previous trial participation, diabetes types 1 or 2, pregnancy or plans to become pregnant soon.Check my eligibility
What is being tested?
The Latino Semaglutide Study is testing the effectiveness of a medication called Semaglutide at a dose of 2.4mg in helping lose and maintain weight loss compared against a placebo. The goal is to understand how this anti-obesity drug works which could lead to more treatments for obesity.See study design
What are the potential side effects?
Semaglutide may cause side effects such as digestive problems (nausea and diarrhea), potential allergic reactions if sensitive to the drug's components; long-term risks are not fully known but could include thyroid tumors based on its class warning.

LSS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.

LSS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and final study visit, seven months post baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and final study visit, seven months post baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of weight loss.
Secondary outcome measures
Food Addiction Assessment

LSS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention GroupActive Control1 Intervention
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 II: Control GroupPlacebo Group1 Intervention
Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,884 Total Patients Enrolled
8 Trials studying Obesity
804 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,414,968 Total Patients Enrolled
141 Trials studying Obesity
131,938 Patients Enrolled for Obesity
Warren Peters, MD, MPHLead Sponsor

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05087342 — Phase 3
Obesity Research Study Groups: Control Group, Intervention Group
Obesity Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05087342 — Phase 3
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087342 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05087342 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would you consider enrolling elderly patients in this research?

"The minimum age requirement to take part in this clinical trial is 18 years old. The maximum age limit is 75."

Answered by AI

Which patients would be a good fit for this clinical trial?

"We are looking for 100 individuals that currently experience weight loss and fall in the age range of 18 to 75 years old. It is important for potential participants to note that they must also have a BMI >30."

Answered by AI

Does the FDA recognize Intervention Group's legitimacy?

"There is prior clinical data supporting Intervention Group's safety, so it received a score of 3."

Answered by AI

How is the average Intervention Group patient treated?

"The Intervention Group is a standard treatment for chronic weight management. It typically includes a combination of reduced-calorie dieting, exercise, and medication for any associated comorbidities."

Answered by AI

Are you currently enrolling people for this research project?

"No, this trial is not recruiting patients at the moment. The last update to the study was on March 24th, 2022 and it was originally posted September 1st, 2022. Even though this particular trial isn't looking for volunteers right now, there are still many other trials (1404 in total) that are."

Answered by AI

What are the unique aspects of this clinical trial?

"Intervention Group has been researched since 2018, with the earliest study being sponsored by Novo Nordisk A/S. After this initial study involving 1387 participants, the drug received Phase 4 approval in 2018. As of now, there are 59 active studies spread out over 55 countries and 766 cities."

Answered by AI

How many people fit the eligibility criteria for this clinical trial?

"Unfortunately, this study is no longer enrolling patients. The listing for the clinical trial was originally published on September 1st 2020 but was last edited on March 24th 2021. If you are interested in other similar studies, there are 1345 active trials involving weight loss and 59 Intervention Group studies that are still recruiting participants."

Answered by AI

Are there any other similar research projects to the one involving Intervention Group?

"As of the current moment, 59 clinical trials are studying the effects of Intervention Group. These 27 live trials in Phase 3 represent the cutting edge of this research. Most studies related to Intervention Group take place in Loma Linda, California; however, there are 3899 locations running these sorts of tests worldwide."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Georgia
California
Other
How old are they?
18 - 65
What site did they apply to?
Loma Linda University Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I need to lose weight. Need help to lose weight. Ready to lose the weight!
PatientReceived no prior treatments
Interested in weight loss. Because my BMI is more than 30.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is screening? Can this be done remotely? Are travel costs included in the trial?
PatientReceived no prior treatments
Are daily visits required? If so, for how long?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Loma Linda University Health: < 24 hours
~0 spots leftby May 2024