S-309309 for Obesity

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

365 Participants Needed

Trial Summary

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.

What safety data exists for S-309309 or similar anti-obesity medications?

The safety of anti-obesity medications has been a concern, with some drugs causing serious side effects like cardiovascular and kidney issues. While some medications have been withdrawn due to adverse effects, others like orlistat and lorcaserin generally have mild, temporary side effects. However, long-term safety data is often lacking, making it important to monitor these medications closely. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Shionogi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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)

Findings from Research

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]

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]

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]

References

1. Netherlands 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Discovery and preclinical efficacy of HSG4112, a synthetic structural analog of glabridin, for the treatment of obesity. [2021]