What is the mechanism of action of this treatment?

Common treatments for obesity, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide) and combination therapies like phentermine-topiramate, primarily work by reducing appetite and increasing feelings of fullness. GLP-1 receptor agonists mimic the incretin hormone GLP-1, which enhances insulin secretion, slows gastric emptying, and promotes satiety. Phentermine-topiramate combines an appetite suppressant with a medication that increases satiety and energy expenditure. These mechanisms are vital for obesity patients as they help manage caloric intake and improve metabolic health, leading to sustainable weight loss and reduced risk of obesity-related comorbidities.

What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists (e.g., semaglutide, liraglutide), phentermine-topiramate, and orlistat, have various side effects. GLP-1 receptor agonists often cause gastrointestinal issues like nausea and vomiting. Phentermine-topiramate can lead to increased heart rate, insomnia, and dry mouth. Orlistat is associated with gastrointestinal side effects, including oily stools and flatulence. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, focusing on weight reduction and management. Notable examples include GLP-1 receptor agonists like liraglutide and semaglutide, which have shown significant efficacy in weight loss through randomized controlled trials. Liraglutide, for instance, demonstrated improved glycemic control and modest weight loss in both adults and pediatric populations. Semaglutide has also been effective, with trials showing substantial weight loss compared to placebo. Additionally, the combination of phentermine and topiramate has been approved, offering enhanced weight loss in the first year of use. These treatments are similar to S-309309 in their aim to manage obesity through pharmacological means.

What other types of research exist?

Promising novel alternatives to S-309309 for obesity treatment in 2024 include: <ol> <li>Tirzepatide: A dual GIP and GLP-1 receptor agonist showing significant weight loss in clinical trials.</li> <li></li> </ol> Semaglutide: A GLP-1 receptor agonist approved for weight management, demonstrating substantial efficacy in reducing body weight. 3. Liraglutide: Another GLP-1 receptor agonist with proven benefits for weight loss and glycemic control. 4. Fixed-dose combination treatments like olanzapine/samidorphan for patients on antipsychotic medications to limit weight gain. These alternatives have shown promising results in clinical trials and are expected to be effective options for obesity management.

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Other

S-309309 for Obesity

Phase 2

Waitlist Available

Research Sponsored by Shionogi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a treatment called S-309309 to see if it can help obese adults lose weight. The treatment may work by reducing hunger or increasing calorie burning.

Who is the study for?

Adults with obesity (BMI ≥ 30 kg/m^2) who have tried and failed at least one diet, have had a stable weight for the last 90 days, and are not pregnant or breastfeeding. Participants must not consume excessive alcohol, use weight-affecting medications or supplements recently, have certain medical conditions like untreated diabetes or inflammatory diseases, nor should they have a history of significant mental health issues.

What is being tested?

The trial is testing the effectiveness of a new medication called S-309309 in reducing body weight compared to a placebo. Obese adults will be randomly assigned to receive either the study drug or an inactive substance to see if there's any difference in their weight loss outcomes.

What are the potential side effects?

While specific side effects for S-309309 aren't listed here, common side effects from weight loss drugs can include digestive issues like nausea and constipation, headaches, dizziness, dry mouth, and potential changes in mood or sleep patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose Level 3: S-309309Experimental Treatment1 Intervention

Participants will receive S-309309 (high dose) once daily for 24 weeks

Group II: Dose Level 2: S-309309Experimental Treatment1 Intervention

Participants will receive S-309309 (middle dose) once daily for 24 weeks

Group III: Dose Level 1: S-309309Experimental Treatment1 Intervention

Participants will receive S-309309 (low dose) once daily for 24 weeks

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo once daily for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

S-309309

2022

Completed Phase 2

~440

Do I qualify?Apply below to find out

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, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide) and combination therapies like phentermine-topiramate, primarily work by reducing appetite and increasing feelings of fullness. GLP-1 receptor agonists mimic the incretin hormone GLP-1, which enhances insulin secretion, slows gastric emptying, and promotes satiety. Phentermine-topiramate combines an appetite suppressant with a medication that increases satiety and energy expenditure. These mechanisms are vital for obesity patients as they help manage caloric intake and improve metabolic health, leading to sustainable weight loss and reduced risk of obesity-related comorbidities.

No Guts, No Loss: Toward the Ideal Treatment for Obesity in the Twenty-First Century.