Safety and Efficacy Study of S-309309 in Obese Adults
- Registration Number
- NCT05925114
- Lead Sponsor
- Shionogi
- Brief Summary
The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose Level 3: S-309309 S-309309 Participants will receive S-309309 (high dose) once daily for 24 weeks Dose Level 2: S-309309 S-309309 Participants will receive S-309309 (middle dose) once daily for 24 weeks Placebo Placebo Participants will receive placebo once daily for 24 weeks Dose Level 1: S-309309 S-309309 Participants will receive S-309309 (low dose) once daily for 24 weeks
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight Baseline, Week 24
- Secondary Outcome Measures
Name Time Method 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 Change From Baseline in Cardiovascular Risk Factors Baseline, 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 Leptin Baseline, Week 24 Change From Baseline in Glucose Metabolism Parameters as Assessed by Fasting Plasma Glucose (FPG) Baseline, Week 24 Change From Baseline in Body Composition: Total Fat Mass as Assessed by DEXA scan 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 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
Trial Locations
- Locations (48)
Catalina Research Institute
🇺🇸Montclair, California, United States
L MARC Research Center
🇺🇸Louisville, Kentucky, United States
Be Well Clinical Studies LLC
🇺🇸Lincoln, Nebraska, United States
Chase Medical Research LLC
🇺🇸Waterbury, Connecticut, United States
Lifeline Primary Care - CCT-PPDS
🇺🇸Lilburn, Georgia, United States
3Sync, LLC
🇺🇸Lake Worth, Florida, United States
Northern California Research Corp
🇺🇸Sacramento, California, United States
Endocrine Consultants Research - Columbus - Centricity Research - HyperCore - PPDS
🇺🇸Columbus, Georgia, United States
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
🇺🇸Fayetteville, Georgia, United States
Helios CR, Inc. - Keller - PPDS
🇺🇸Keller, Texas, United States
AES - DRS - Synexus Clinical Research US, Inc
🇺🇸Murray, Utah, United States
Manasas Clinical Research Center
🇺🇸Manassas, Virginia, United States
AES - DRS - Synexus Clinical Research US, Inc.
🇺🇸Akron, Ohio, United States
Lynn Institute of East Oklahoma - ERN PPDS
🇺🇸Oklahoma City, Oklahoma, United States
Olympus Family Medicine - CCT - PPDS
🇺🇸Salt Lake City, Utah, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Tryon Medical Practice - Ballantyne - Javara - PPDS
🇺🇸Charlotte, North Carolina, United States
Medical Care, LLC
🇺🇸Elizabethton, Tennessee, United States
Encompass Clinical Research - ClinEdge - PPDS
🇺🇸Spring Valley, California, United States
Oviedo Medical Research - ClinEdge PPDs
🇺🇸Oviedo, Florida, United States
South Ogden Family Medicine
🇺🇸South Ogden, Utah, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Flourish Research - Ravenswood - PPDS
🇺🇸Chicago, Illinois, United States
Suncoast Research Group LLC - Flourish - PPDS
🇺🇸Miami, Florida, United States
Helios CR Ins Houston - PPDS
🇺🇸Houston, Texas, United States
Juno Research LLC
🇺🇸Houston, Texas, United States
Edrocrine and Psychiatry Center
🇺🇸Houston, Texas, United States
Annapolis Internal Medicine, LLC
🇺🇸Annapolis, Maryland, United States
Privia Medical Group Mid-Atlantic - Javara - PPDS
🇺🇸Silver Spring, Maryland, United States
Palm Research Center, Inc
🇺🇸Las Vegas, Nevada, United States
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
🇺🇸Cincinnati, Ohio, United States
Flourish Research
🇺🇸San Antonio, Texas, United States
Diabetes and Gandular Disease Clinic, PA
🇺🇸San Antonio, Texas, United States
Consano Clinical Research
🇺🇸San Antonio, Texas, United States
Ogden Clinic - Grand View
🇺🇸Roy, Utah, United States
Flourish Research - Birmingham - PPDS
🇺🇸Birmingham, Alabama, United States
Synexus Clinical Research
🇺🇸Birmingham, Alabama, United States
Foothills Research Center - CCT - PPDS
🇺🇸Phoenix, Arizona, United States
National Research Institute - ClinEdge - PPDS
🇺🇸Los Angeles, California, United States
Angels Clinical Research Institute-Miami
🇺🇸Miami Lakes, Florida, United States
A G A Clininical Trials- HyperCore PPDS
🇺🇸Hialeah, Florida, United States
Westside Center for Clinical Research - ERN - PPDS
🇺🇸Jacksonville, Florida, United States
Hatboro Medical Associates PC
🇺🇸Hatboro, Pennsylvania, United States
Boston Clinical Trials Inc. - Alcanza - HyperCore - PPDS
🇺🇸Boston, Massachusetts, United States
Vytalus Medical Group
🇺🇸Kingwood, Texas, United States
ActivMed Practices & Research, Inc. - Portsmouth - Alcanza - HyperCore - PPDS
🇺🇸Methuen, Massachusetts, United States
Charlottesville Medical Research Center
🇺🇸Charlottesville, Virginia, United States
Lucas Research - Hickory - HyperCore - PPDS
🇺🇸Hickory, North Carolina, United States