> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-study-of-s-309309-in-obese-adults-f03c2f42-9266-487d-ac7b-9473a4a7dfb1 > Record changed: 2026-11-04 # Safety and Efficacy Study of S-309309 in Obese Adults NCT05925114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) Participants 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) Lead sponsor Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) Start date 2023-06-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) Number of sites 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Title and summary **Summary** The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Short title** Safety and Efficacy Study of S-309309 in Obese Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Official title** A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Assess the Safety and Efficacy of S-309309 in Obese Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Dates **Completion date** 2024-05-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **First posted** 2023-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Registry last updated** 2025-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Primary completion date** 2024-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Start date** 2023-06-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Size and sites **Actual participants** 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Participants** 365 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Number of sites** 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Lead sponsor** Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Identifiers **Registry ID** NCT05925114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **ClinicalTrials.gov ID** NCT05925114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Outcomes ### Primary outcomes 1. Percent Change From Baseline in Body Weight Timeframe: Baseline, Week 24 ### Secondary outcomes 1. Percentage of Participants Achieving a Weight Loss of ≥ 5% Timeframe: Baseline to Week 24 2. Percentage of Participants Achieving a Weight Loss of ≥ 10% Timeframe: Baseline to Week 24 3. Percentage of Participants Achieving a Weight Loss of ≥ 15% Timeframe: Baseline to Week 24 4. Percentage of Participants Achieving a Weight Loss of ≥ 20% Timeframe: Baseline to Week 24 5. Change From Baseline in Waist Circumference Timeframe: Baseline, Week 24 6. Change From Baseline in Hip/Waist Ratio Timeframe: Baseline, Week 24 7. Change From Baseline in BMI Timeframe: Baseline, Week 24 8. Change From Baseline in Glucose Metabolism Parameters as Assessed by Hemoglobin A1c or Glycosylated Hemoglobin (HbA1c) Timeframe: Baseline, Week 24 9. Change From Baseline in Glucose Metabolism Parameters as Assessed by Fasting Plasma Glucose (FPG) Timeframe: Baseline, Week 24 10. Change From Baseline in Cardiovascular Risk Factors Timeframe: Baseline, Week 24 11. Change From Baseline in Body Composition: Total Fat Mass as Assessed by DEXA scan Timeframe: Baseline, Week 24 12. Change From Baseline in Body Composition: Lean Mass as Assessed by DEXA scan Timeframe: Baseline, Week 24 13. Change From Baseline in Body Composition: Visceral Fat Mass as Assessed by DEXA scan Timeframe: Baseline, Week 24 14. Plasma Concentration of S-309309 Timeframe: Up to 24 weeks 15. Change From Baseline in Adiponectin Timeframe: Baseline, Week 24 16. Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) Timeframe: Baseline, Week 24 17. Change From Baseline in Leptin Timeframe: Baseline, Week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: 1. BMI of ≥ 30 kg/m^2 (obese) with or without comorbidities. An online BMI calculator is available at Calculate Your BMI - Standard BMI Calculator (nih.gov) 2. Stable body weight (defined as ≤ 5 kg of self-reported change) within 90 days prior to study start 3. Lifetime history of at least 1 unsuccessful dietary effort to lose body weight 4. 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. Key Exclusion Criteria: 1. Obesity of known endocrine origin (eg, untreated hypothyroidism, Cushing's syndrome) 2. Medical history or characteristics suggestive of genetic obesity 3. Any lifetime history of a suicide attempt or history of any suicidal ideation within the past year before entry into the study 4. History of documented human immunodeficiency virus (HIV) infection 5. History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data 6. History of inflammatory conditions and autoimmune diseases 7. Males: a QT interval corrected using Fridericia's formula (QTcF) interval of > 450 msec at the Screening Visit; females: a QTcF interval > 470 msec at the Screening Visit 8. Active malignancy or history of malignancy (other than nonmelanoma skin cancer or any grade intraepithelial cervical neoplasia that has been surgically treated) within 5 years of enrollment in this study 9. A severe psychiatric condition, such as schizophrenia, bipolar disorder, or major depression in the previous 2 years before the Screening Visit, or history of treatment with antipsychotics, antidepressants, or mood stabilizers in the previous 2 years before the Screening Visit. 10. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days prior to the Screening Visit 11. A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at the Screening Visit 12. History of an eating disorder (eg, bulimia or anorexia nervosa) 13. History of drug or alcohol abuse within 5 years of the Screening Visit 14. A self-reported change in body weight > 5 kg (11 pounds \[lbs\]) within 90 days prior to the Screening Visit 15. Known history of treated or untreated diabetes 16. Baseline hemoglobin A1c (HbA1c) ≥ 6.5% at the Screening Visit 17. Alanine aminotransaminase (ALT) > 3 × upper limit of normal (ULN) at the Screening Visit 18. Aspartate aminotransaminase (AST) > 3 × ULN at the Screening Visit 19. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at the Screening Visit 20. Chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, Gilbert's syndrome or gallstones) 21. Any underlying lens opacity that affects the BCVA, or any posterior subcapsular opacity ≥ P1 based on the LOCS III, even if not impacting the BCVA 22. Marijuana use within 90 days prior to the Screening Visit 23. Use of medications that the investigator considers to be associated with weight changes within 90 days prior to the Screening Visit 24. Concomitant or previous steroid treatments (including eye-drops, inhalers, and nebulizers) for a total of ≥ 15 days during the 24 weeks prior to the Screening Visit; dermatological preparations of steroids will be allowed 25. History of or planned bariatric surgery or intra-abdominal balloon during study participation 26. Concomitant use of any dietary or herbal supplement that is indicated for weight management or maintenance of healthy weight 27. Use of drugs or substances known to be inducers or inhibitors of P-glycoprotein (P-gp) within 28 days prior to dosing 28. Received any investigational drug within 3 months of the Screening Visit 29. History of coronavirus disease 2019 (COVID-19) infection within 14 days prior to the Screening Visit or close contact with a COVID-19 patient in the 14 days prior to the Screening Visit as reported by the participant and the participant's medical history 30. Presence of HIV antibody at the Screening Visit or within 90 days prior to the Screening Visit 31. Regularly consumes excessive amounts of alcohol, defined as > 3 glasses of alcoholic beverages per day 32. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy, that, in the opinion of the investigator or medical monitor, contraindicates participation in the study 33. Female study participants who have a positive urine pregnancy test at the Screening Visit 34. Female study participants who are breastfeeding 35. Poor venous access based on the investigator's judgement 36. Unable to swallow capsules 37. Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration < 11.5 g/dL for males, < 10.5 g/dL for females) at the Screening Visit or any other condition known to interfere with interpretation of HbA1c measurement Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Sites - Flourish Research - Birmingham - PPDSBirmingham, United States - Synexus Clinical ResearchBirmingham, United States - Foothills Research Center - CCT - PPDSPhoenix, United States - National Research Institute - ClinEdge - PPDSLos Angeles, United States - Catalina Research InstituteMontclair, United States - Northern California Research CorpSacramento, United States - Encompass Clinical Research - ClinEdge - PPDSSpring Valley, United States - Chase Medical Research LLCWaterbury, United States - A G A Clininical Trials- HyperCore PPDSHialeah, United States - Westside Center for Clinical Research - ERN - PPDSJacksonville, United States - 3Sync, LLCLake Worth, United States - Suncoast Research Group LLC - Flourish - PPDSMiami, United States - Angels Clinical Research Institute-MiamiMiami Lakes, United States - Oviedo Medical Research - ClinEdge PPDsOviedo, United States - Precision Clinical ResearchSunrise, United States - Endocrine Consultants Research - Columbus - Centricity Research - HyperCore - PPDSColumbus, United States - Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDSFayetteville, United States - Lifeline Primary Care - CCT-PPDSLilburn, United States - Flourish Research - Ravenswood - PPDSChicago, United States - L MARC Research CenterLouisville, United States - Annapolis Internal Medicine, LLCAnnapolis, United States - Privia Medical Group Mid-Atlantic - Javara - PPDSSilver Spring, United States - Boston Clinical Trials Inc. - Alcanza - HyperCore - PPDSBoston, United States - ActivMed Practices & Research, Inc. - Portsmouth - Alcanza - HyperCore - PPDSMethuen, United States - Be Well Clinical Studies LLCLincoln, United States And 24 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05925114) ## Related records ### Drugs (1) - [S-309309](https://trialight.com/data/asset/s-309309-c818ae52-76ce-5645-8186-d180475caf6e.md) ### Lead sponsors (1) - [Shionogi](https://trialight.com/data/company/shionogi-b43f8414-7488-436b-b4cd-1fb0330070e3.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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