What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists (liraglutide, semaglutide), orlistat, and phentermine-topiramate, have several known side effects. GLP-1 receptor agonists often cause gastrointestinal issues like nausea and vomiting. Orlistat can lead to gastrointestinal discomfort, oily stools, and potential fat-soluble vitamin deficiencies. Phentermine-topiramate may cause dry mouth, insomnia, dizziness, and an increased heart rate. These side effects should be considered when choosing an appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity that work through various mechanisms. For instance, liraglutide, a GLP-1 receptor agonist, helps with weight loss by suppressing appetite and slowing gastric emptying. Another example is orlistat, which inhibits fat absorption in the intestines. Additionally, medications like phentermine-topiramate work by suppressing appetite and increasing metabolism. These drugs have shown efficacy in clinical trials and are part of the broader strategy to manage obesity through pharmacotherapy.

What other types of research exist?

Promising novel alternatives to anti-obesity medications for 2024 include: 1) Ghrelin receptor antagonists, which block orexigenic signals to suppress appetite. 2) GLP-1 agonists like liraglutide, which increase metabolism and promote weight loss. 3) Fixed-dose combination treatments like olanzapine/samidorphan to limit weight gain in patients on antipsychotic medications. These alternatives have shown efficacy in clinical trials and are under intensive investigation.

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Glucagon-like peptide-1 receptor agonist

Semaglutide for Obesity (LSS Trial)

Phase 3

Waitlist Available

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

Must not have

Any known or suspected allergy to semaglutide 2.4 mg or related products

Current cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and month four of treatment.

Awards & highlights

Pivotal Trial

Summary

This trial is testing a drug designed to help people with obesity lose weight and keep it off. The study aims to understand how the medication works, which could lead to the development of similar drugs. The medication may help by affecting metabolism or appetite.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to semaglutide or similar medications.

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I am currently receiving treatment for cancer.

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I am taking medication that targets the GPL-1 system.

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I do not have any genetic disorders or disabilities that would prevent me from fully participating in the study.

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I have diabetes.

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I don't have a history of specific thyroid cancer or genetic conditions, and I'm not allergic to semaglutide.

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I have had weight loss surgery in the past.

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I am taking medication that causes weight gain and cannot stop or change it.

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I've lost more than 5 pounds in the last month through diet, exercise, or medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and final study visit, seven months post baseline.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of weight loss.

Secondary study objectives

Food Addiction Assessment

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity often work through three primary mechanisms: appetite suppression, increased metabolism, and fat absorption inhibition. Appetite suppressants, such as GLP-1 agonists, reduce hunger and caloric intake by acting on the central nervous system. Medications that increase metabolism, like certain stimulants, enhance the body's energy expenditure, helping to burn more calories. Fat absorption inhibitors, such as orlistat, prevent the digestion and absorption of dietary fats, reducing overall caloric intake. These mechanisms are vital for obesity patients as they help manage weight by addressing both the intake and expenditure of calories, leading to more effective and sustainable weight loss.

Pharmacotherapy of obesity: emerging drugs and targets.