Safety and Efficacy Study of S-309309 in Obese Adults

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)
• Stable body weight (defined as ≤ 5 kg of self-reported change) within 90 days prior to study start
• 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.

Key Exclusion Criteria:

• Obesity of known endocrine origin (eg, untreated hypothyroidism, Cushing's syndrome)
• Medical history or characteristics suggestive of genetic obesity
• Any lifetime history of a suicide attempt or history of any suicidal ideation within the past year before entry into the study
• History of documented human immunodeficiency virus (HIV) infection
• 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
• History of inflammatory conditions and autoimmune diseases
• 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
• 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
• 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.
• 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
• A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at the Screening Visit
• History of an eating disorder (eg, bulimia or anorexia nervosa)
• History of drug or alcohol abuse within 5 years of the Screening Visit
• A self-reported change in body weight > 5 kg (11 pounds [lbs]) within 90 days prior to the Screening Visit
• Known history of treated or untreated diabetes
• Baseline hemoglobin A1c (HbA1c) ≥ 6.5% at the Screening Visit
• Alanine aminotransaminase (ALT) > 3 × upper limit of normal (ULN) at the Screening Visit
• Aspartate aminotransaminase (AST) > 3 × ULN at the Screening Visit
• 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
• 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)
• 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
• Marijuana use within 90 days prior to the Screening Visit
• Use of medications that the investigator considers to be associated with weight changes within 90 days prior to the Screening Visit
• 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
• History of or planned bariatric surgery or intra-abdominal balloon during study participation
• Concomitant use of any dietary or herbal supplement that is indicated for weight management or maintenance of healthy weight
• Use of drugs or substances known to be inducers or inhibitors of P-glycoprotein (P-gp) within 28 days prior to dosing
• Received any investigational drug within 3 months of the Screening Visit
• 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
• Presence of HIV antibody at the Screening Visit or within 90 days prior to the Screening Visit
• Regularly consumes excessive amounts of alcohol, defined as > 3 glasses of alcoholic beverages per day
• 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
• Female study participants who have a positive urine pregnancy test at the Screening Visit
• Female study participants who are breastfeeding
• Poor venous access based on the investigator's judgement
• Unable to swallow capsules
• 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.