S-309309 for Obesity

No longer recruiting at 48 trial locations

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Shionogi

Must not be taking: Antipsychotics, Antidepressants, Mood stabilizers

Disqualifiers: Diabetes, HIV, Cardiovascular disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, S-309309, to determine its effectiveness in helping people with obesity lose weight. Participants will receive varying doses of the treatment or a placebo (a substance with no therapeutic effect) over 24 weeks. The trial aims to identify the most effective dose. Suitable candidates are those with a BMI of 30 or more, a stable weight for the past three months, and unsuccessful weight loss attempts through dieting. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications associated with weight changes or certain supplements for weight management. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that S-309309 has potential in treating obesity based on earlier studies. Preclinical research suggests it might aid weight management in a unique way. Regarding safety, studies indicate that S-309309 is generally well-tolerated, with no major issues in absorption, even considering obesity or food intake.

As a Phase 2 trial, the treatment has already passed initial safety tests in earlier studies. This phase aims to further explore its effectiveness while continuing to monitor for any side effects. Prospective participants should know that the treatment has undergone safety evaluation before reaching this stage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about S-309309 for obesity because it offers a novel approach compared to existing treatments like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists. S-309309 is being explored in varying dosages, which could provide flexibility in treatment and potentially enhance its effectiveness and safety profile. This drug might target obesity through a unique mechanism or active ingredient, setting it apart from traditional options and potentially offering new hope for those struggling with weight management.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that S-309309 has potential for aiding weight loss in mice with diet-related obesity. This trial will evaluate different dosages of S-309309 to determine its effectiveness in humans. Although some study results have been disappointing, indicating uncertainty about its effectiveness, S-309309 has not affected certain body functions like liver enzymes. More information is needed to understand its effectiveness for weight loss in humans. ^{1 2 3 4 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Shionogi

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My BMI is 30 or higher, indicating obesity.

Lifetime history of at least 1 unsuccessful dietary effort to lose body weight

Is a participant of non-childbearing potential (PONCBP) OR Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective as specified in the protocol. A POCBP must have a negative highly sensitive pregnancy test (urine or serum) before a first dose of study intervention as per protocol.

Exclusion Criteria

History of an eating disorder (eg, bulimia or anorexia nervosa)

Aspartate aminotransaminase (AST) > 3 × ULN at the Screening Visit

I have been diagnosed with HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive S-309309 or placebo once daily for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• S-309309

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Level 3: S-309309 Experimental Treatment 1 Intervention

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

Group II: Dose Level 2: S-309309 Experimental Treatment 1 Intervention

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

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

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

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo once daily for 24 weeks

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials

122

Recruited

42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)

Published Research Related to This Trial

New generation anti-obesity medications, such as orlistat, phentermine/topiramate, and liraglutide 3.0 mg, have varying safety profiles, with some presenting significant risks like fetal toxicity and gallstone disease, while others mainly cause transient tolerability issues.

Despite their effectiveness in weight loss, the prescription rates for these medications are low, partly due to safety concerns and the need for more long-term data to better understand their risk-benefit profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. Patel, DK., Stanford, FC.[2023]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

Three FDA-approved medications for long-term obesity treatment—sibutramine, orlistat, and rimonabant—have shown significant weight loss benefits in large clinical trials lasting 2 to 4 years, with average weight loss of 8%-10% compared to 4%-6% for placebo.

While all medications have side effects, sibutramine can increase blood pressure and heart rate, orlistat can cause gastrointestinal issues like steatorrhea, and rimonabant generally has a favorable safety profile with mild, self-limited nausea and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. Bray, GA., Ryan, DH.[2018]

HSG4112, an optimized analog of glabridin, was found to be more effective and stable than glabridin in promoting weight loss in obese mice, demonstrating significant improvements in obesity-related parameters after six weeks of treatment.

The weight loss effects of HSG4112 were primarily due to increased energy expenditure rather than reduced physical activity or food intake, indicating a potential mechanism of action that enhances metabolic rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery and preclinical efficacy of HSG4112, a synthetic structural analog of glabridin, for the treatment of obesity. Choi, LS., Jo, IG., Kang, KS., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05925114

Safety and Efficacy Study of S-309309 in Obese Adults A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Assess the Safety and Efficacy of S-309309 in Obese Adults.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39832041/

Safety, Tolerability, and Pharmacokinetics of a Novel Anti ... The pharmacokinetic characteristics remained unaffected by obesity and food intake. S-309309 did not affect the pharmacokinetics of the cytochrome P450 3A ...

3. link.springer.com link.springer.com/article/10.1007/s40261-024-01418-3

Safety, Tolerability, and Pharmacokinetics of a Novel Anti ... As demonstrated, S-309309 has shown effectiveness in weight management in the diet-induced obesity mice model. Therefore, we are developing S- ...

4. biocentury.com biocentury.com/article/652663/clinical-report-shionogi-mulls-next-steps-after-underwhelming-obesity-readout

Shionogi mulls next steps after underwhelming obesity ... A disappointing clinical outcome for Shionogi's obesity candidate shaved 13% from its stock price Friday, although the pharma is considering combination ...

5. shionogi.com shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2023/1q/%E8%8B%B1%E8%AA%9E%E3%82%B9%E3%82%AF%E3%83%AA%E3%83%97%E3%83%88.pdf

SHIONOGI & CO., LTD. We will explain about our focus on S-309309, an anti-obesity drug, and Resiniferatoxin, an analgesic drug, in the following pages. Page 15.

6. sigma.larvol.com sigma.larvol.com/product.php?e1=1027314&tab=newstrac

S-309309 News Also, S-309309 improved insulin sensitivity and fatty liver. Taken together, these results suggest that S-309309 may be a promising anti-obesity drug that ...