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The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1: S-309309 | Experimental | Participants will receive S-309309 (low dose) once daily for 24 weeks |
|
| Dose Level 2: S-309309 | Experimental | Participants will receive S-309309 (middle dose) once daily for 24 weeks |
|
| Dose Level 3: S-309309 | Experimental | Participants will receive S-309309 (high dose) once daily for 24 weeks |
|
| Placebo | Placebo Comparator | Participants will receive placebo once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-309309 | Drug | Administered as oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Weight Loss of ≥ 5% | Baseline to Week 24 | |
| Percentage of Participants Achieving a Weight Loss of ≥ 10% | Baseline to Week 24 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flourish Research - Birmingham - PPDS | Birmingham | Alabama | 35205-1605 | United States | ||
| Synexus Clinical Research |
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| Placebo | Drug | Administered as an oral capsule that looks identical to S-309309 capsule |
|
| Percentage of Participants Achieving a Weight Loss of ≥ 15% |
| Baseline to Week 24 |
| Percentage of Participants Achieving a Weight Loss of ≥ 20% | Baseline to Week 24 |
| Change From Baseline in Waist Circumference | Baseline, Week 24 |
| Change From Baseline in Hip/Waist Ratio | Baseline, Week 24 |
| Change From Baseline in BMI | Baseline, Week 24 |
| Change From Baseline in Glucose Metabolism Parameters as Assessed by Hemoglobin A1c or Glycosylated Hemoglobin (HbA1c) | Baseline, Week 24 |
| Change From Baseline in Glucose Metabolism Parameters as Assessed by Fasting Plasma Glucose (FPG) | Baseline, Week 24 |
| Change From Baseline in Cardiovascular Risk Factors | Baseline, Week 24 |
| Change From Baseline in Body Composition: Total Fat Mass as Assessed by DEXA scan | Baseline, Week 24 |
| Change From Baseline in Body Composition: Lean Mass as Assessed by DEXA scan | Baseline, Week 24 |
| Change From Baseline in Body Composition: Visceral Fat Mass as Assessed by DEXA scan | Baseline, Week 24 |
| Plasma Concentration of S-309309 | Up to 24 weeks |
| Change From Baseline in Adiponectin | Baseline, Week 24 |
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline, Week 24 |
| Change From Baseline in Leptin | Baseline, Week 24 |
| Birmingham |
| Alabama |
| 35211-1320 |
| United States |
| Foothills Research Center - CCT - PPDS | Phoenix | Arizona | 85044-6097 | United States |
| National Research Institute - ClinEdge - PPDS | Los Angeles | California | 90057-3550 | United States |
| Catalina Research Institute | Montclair | California | 91763-2231 | United States |
| Northern California Research Corp | Sacramento | California | 95821-2640 | United States |
| Encompass Clinical Research - ClinEdge - PPDS | Spring Valley | California | 91978-1522 | United States |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708-3346 | United States |
| A G A Clininical Trials- HyperCore PPDS | Hialeah | Florida | 33012-3407 | United States |
| Westside Center for Clinical Research - ERN - PPDS | Jacksonville | Florida | 32205-4785 | United States |
| 3Sync, LLC | Lake Worth | Florida | 33460-4400 | United States |
| Suncoast Research Group LLC - Flourish - PPDS | Miami | Florida | 33135-1687 | United States |
| Angels Clinical Research Institute-Miami | Miami Lakes | Florida | 33016-1598 | United States |
| Oviedo Medical Research - ClinEdge PPDs | Oviedo | Florida | 32765-4515 | United States |
| Precision Clinical Research | Sunrise | Florida | 333351-7311 | United States |
| Endocrine Consultants Research - Columbus - Centricity Research - HyperCore - PPDS | Columbus | Georgia | 31904-4501 | United States |
| Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS | Fayetteville | Georgia | 302140-1578 | United States |
| Lifeline Primary Care - CCT-PPDS | Lilburn | Georgia | 30047 | United States |
| Flourish Research - Ravenswood - PPDS | Chicago | Illinois | 60640-7927 | United States |
| L MARC Research Center | Louisville | Kentucky | 40213-1014 | United States |
| Annapolis Internal Medicine, LLC | Annapolis | Maryland | 21401-7050 | United States |
| Privia Medical Group Mid-Atlantic - Javara - PPDS | Silver Spring | Maryland | 20901-4402 | United States |
| Boston Clinical Trials Inc. - Alcanza - HyperCore - PPDS | Boston | Massachusetts | 02131-2515 | United States |
| ActivMed Practices & Research, Inc. - Portsmouth - Alcanza - HyperCore - PPDS | Methuen | Massachusetts | 01844 | United States |
| Be Well Clinical Studies LLC | Lincoln | Nebraska | 68516 | United States |
| Palm Research Center, Inc | Las Vegas | Nevada | 89148-5613 | United States |
| Tryon Medical Practice - Ballantyne - Javara - PPDS | Charlotte | North Carolina | 28287-3884 | United States |
| Lucas Research - Hickory - HyperCore - PPDS | Hickory | North Carolina | 28601-3829 | United States |
| AES - DRS - Synexus Clinical Research US, Inc. | Akron | Ohio | 44311-1012 | United States |
| Velocity Clinical Research (Cincinnati - Ohio) - PPDS | Cincinnati | Ohio | 45219-2975 | United States |
| Lynn Institute of East Oklahoma - ERN PPDS | Oklahoma City | Oklahoma | 73104-5033 | United States |
| Hatboro Medical Associates PC | Hatboro | Pennsylvania | 19040-2024 | United States |
| Medical Care, LLC | Elizabethton | Tennessee | 47643-2654 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230-6885 | United States |
| Helios CR Ins Houston - PPDS | Houston | Texas | 77008-1366 | United States |
| Juno Research LLC | Houston | Texas | 77040-5063 | United States |
| Juno Research LLC | Houston | Texas | 77054 | United States |
| Edrocrine and Psychiatry Center | Houston | Texas | 77095-2856 | United States |
| Helios CR, Inc. - Keller - PPDS | Keller | Texas | 76248-4235 | United States |
| Vytalus Medical Group | Kingwood | Texas | 77339 | United States |
| Flourish Research | San Antonio | Texas | 78229-3539 | United States |
| Diabetes and Gandular Disease Clinic, PA | San Antonio | Texas | 78229-4801 | United States |
| Consano Clinical Research | San Antonio | Texas | 78258-3916 | United States |
| AES - DRS - Synexus Clinical Research US, Inc | Murray | Utah | 84123-2967 | United States |
| Ogden Clinic - Grand View | Roy | Utah | 84067-9438 | United States |
| Olympus Family Medicine - CCT - PPDS | Salt Lake City | Utah | 84117 | United States |
| South Ogden Family Medicine | South Ogden | Utah | 84405 | United States |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911-3589 | United States |
| Manasas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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