Safety and Efficacy Study of S-309309 in Obese Adults
Study Details
Study Description
Brief Summary
The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Level 1: S-309309 Participants will receive S-309309 (low dose) once daily for 24 weeks |
Drug: S-309309
Administered as oral capsules
|
| Experimental: Dose Level 2: S-309309 Participants will receive S-309309 (middle dose) once daily for 24 weeks |
Drug: S-309309
Administered as oral capsules
|
| Experimental: Dose Level 3: S-309309 Participants will receive S-309309 (high dose) once daily for 24 weeks |
Drug: S-309309
Administered as oral capsules
|
| Placebo Comparator: Placebo Participants will receive placebo once daily for 24 weeks |
Drug: Placebo
Administered as an oral capsule that looks identical to S-309309 capsule
|
Outcome Measures
Primary Outcome Measures
- Percent Change From Baseline in Body Weight [Baseline, Week 24]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
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)
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Stable body weight (defined as ≤ 5 kg of self-reported change) within 90 days prior to study start
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Lifetime history of at least 1 unsuccessful dietary effort to lose body weight
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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.
-
There will be no study contraception requirements for males
Key Exclusion Criteria:
-
Obesity of known endocrine origin (eg, untreated hypothyroidism, Cushing's syndrome)
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Medical history or characteristics suggestive of genetic obesity
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Any lifetime history of a suicide attempt or history of any suicidal ideation within the past year before entry into the study
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History of documented human immunodeficiency virus (HIV) infection
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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
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History of inflammatory conditions and autoimmune diseases
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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
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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
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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.
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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
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A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at the Screening Visit
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History of an eating disorder (eg, bulimia or anorexia nervosa)
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History of drug or alcohol abuse within 5 years of the Screening Visit
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A self-reported change in body weight > 5 kg (11 pounds [lbs]) within 90 days prior to the Screening Visit
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Known history of treated or untreated diabetes
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Baseline hemoglobin A1c (HbA1c) ≥ 6.5% at the Screening Visit
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Alanine aminotransaminase (ALT) > 3 × upper limit of normal (ULN) at the Screening Visit
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Aspartate aminotransaminase (AST) > 3 × ULN at the Screening Visit
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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
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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)
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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
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Marijuana use within 90 days prior to the Screening Visit
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Use of medications that the investigator considers to be associated with weight changes within 90 days prior to the Screening Visit
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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
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History of or planned bariatric surgery or intra-abdominal balloon during study participation
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Concomitant use of any dietary or herbal supplement that is indicated for weight management or maintenance of healthy weight
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Use of drugs or substances known to be inducers or inhibitors of P-glycoprotein (P-gp) within 28 days prior to dosing
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Received any investigational drug within 3 months of the Screening Visit
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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
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Presence of HIV antibody at the Screening Visit or within 90 days prior to the Screening Visit
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Regularly consumes excessive amounts of alcohol, defined as > 3 glasses of alcoholic beverages per day
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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
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Female study participants who have a positive urine pregnancy test at the Screening Visit
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Female study participants who are breastfeeding
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Poor venous access based on the investigator's judgement
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Unable to swallow capsules
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Edrocrine and Psychiatry Center | Houston | Texas | United States | 77095-2856 |
| 2 | Consano Clinical Research | San Antonio | Texas | United States | 78258-3916 |
| 3 | Charlottesville Medical Research Center | Charlottesville | Virginia | United States | 22911-3589 |
Sponsors and Collaborators
- Shionogi
Investigators
- Study Director: Medical Director, Shionogi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2201N1121