Safety and Efficacy Study of S-309309 in Obese Adults

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05925114
• Other study ID #: 2201N1121
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 21, 2023
• Est. completion date: May 23, 2024

Study information

• Verified date: October 2023
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 365
• Est. completion date: May 23, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• S-309309
Administered as oral capsules
• Placebo
Administered as an oral capsule that looks identical to S-309309 capsule

Locations

Country	Name	City	State
United States	AES - DRS - Synexus Clinical Research US, Inc.	Akron	Ohio
United States	Annapolis Internal Medicine, LLC	Annapolis	Maryland
United States	Flourish Research - Birmingham - PPDS	Birmingham	Alabama
United States	Synexus Clinical Research	Birmingham	Alabama
United States	Boston Clinical Trials Inc. - Alcanza - HyperCore - PPDS	Boston	Massachusetts
United States	Tryon Medical Practice - Ballantyne - Javara - PPDS	Charlotte	North Carolina
United States	Charlottesville Medical Research Center	Charlottesville	Virginia
United States	Flourish Research - Ravenswood - PPDS	Chicago	Illinois
United States	Velocity Clinical Research (Cincinnati - Ohio) - PPDS	Cincinnati	Ohio
United States	Endocrine Consultants Research - Columbus - Centricity Research - HyperCore - PPDS	Columbus	Georgia
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Medical Care, LLC	Elizabethton	Tennessee
United States	Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS	Fayetteville	Georgia
United States	Hatboro Medical Associates PC	Hatboro	Pennsylvania
United States	A G A Clininical Trials- HyperCore PPDS	Hialeah	Florida
United States	Lucas Research - Hickory - HyperCore - PPDS	Hickory	North Carolina
United States	Edrocrine and Psychiatry Center	Houston	Texas
United States	Helios CR Ins Houston - PPDS	Houston	Texas
United States	Juno Research LLC	Houston	Texas
United States	Juno Research LLC	Houston	Texas
United States	Westside Center for Clinical Research - ERN - PPDS	Jacksonville	Florida
United States	Helios CR, Inc. - Keller - PPDS	Keller	Texas
United States	Vytalus Medical Group	Kingwood	Texas
United States	3Sync, LLC	Lake Worth	Florida
United States	Palm Research Center, Inc	Las Vegas	Nevada
United States	Lifeline Primary Care - CCT-PPDS	Lilburn	Georgia
United States	Be Well Clinical Studies LLC	Lincoln	Nebraska
United States	National Research Institute - ClinEdge - PPDS	Los Angeles	California
United States	L MARC Research Center	Louisville	Kentucky
United States	Manasas Clinical Research Center	Manassas	Virginia
United States	ActivMed Practices & Research, Inc. - Portsmouth - Alcanza - HyperCore - PPDS	Methuen	Massachusetts
United States	Suncoast Research Group LLC - Flourish - PPDS	Miami	Florida
United States	Angels Clinical Research Institute-Miami	Miami Lakes	Florida
United States	Catalina Research Institute	Montclair	California
United States	AES - DRS - Synexus Clinical Research US, Inc	Murray	Utah
United States	Lynn Institute of East Oklahoma - ERN PPDS	Oklahoma City	Oklahoma
United States	Oviedo Medical Research - ClinEdge PPDs	Oviedo	Florida
United States	Foothills Research Center - CCT - PPDS	Phoenix	Arizona
United States	Ogden Clinic - Grand View	Roy	Utah
United States	Northern California Research Corp	Sacramento	California
United States	Olympus Family Medicine - CCT - PPDS	Salt Lake City	Utah
United States	Consano Clinical Research	San Antonio	Texas
United States	Diabetes and Gandular Disease Clinic, PA	San Antonio	Texas
United States	Flourish Research	San Antonio	Texas
United States	Privia Medical Group Mid-Atlantic - Javara - PPDS	Silver Spring	Maryland
United States	South Ogden Family Medicine	South Ogden	Utah
United States	Encompass Clinical Research - ClinEdge - PPDS	Spring Valley	California
United States	Precision Clinical Research	Sunrise	Florida
United States	Chase Medical Research LLC	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Body Weight		Baseline, Week 24
Secondary	Percentage of Participants Achieving a Weight Loss of = 5%		Baseline to Week 24
Secondary	Percentage of Participants Achieving a Weight Loss of = 10%		Baseline to Week 24
Secondary	Percentage of Participants Achieving a Weight Loss of = 15%		Baseline to Week 24
Secondary	Percentage of Participants Achieving a Weight Loss of = 20%		Baseline to Week 24
Secondary	Change From Baseline in Waist Circumference		Baseline, Week 24
Secondary	Change From Baseline in Hip/Waist Ratio		Baseline, Week 24
Secondary	Change From Baseline in BMI		Baseline, Week 24
Secondary	Change From Baseline in Glucose Metabolism Parameters as Assessed by Hemoglobin A1c or Glycosylated Hemoglobin (HbA1c)		Baseline, Week 24
Secondary	Change From Baseline in Glucose Metabolism Parameters as Assessed by Fasting Plasma Glucose (FPG)		Baseline, Week 24
Secondary	Change From Baseline in Cardiovascular Risk Factors		Baseline, Week 24
Secondary	Change From Baseline in Body Composition: Total Fat Mass as Assessed by DEXA scan		Baseline, Week 24
Secondary	Change From Baseline in Body Composition: Lean Mass as Assessed by DEXA scan		Baseline, Week 24
Secondary	Change From Baseline in Body Composition: Visceral Fat Mass as Assessed by DEXA scan		Baseline, Week 24
Secondary	Plasma Concentration of S-309309		Up to 24 weeks
Secondary	Change From Baseline in Adiponectin		Baseline, Week 24
Secondary	Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)		Baseline, Week 24
Secondary	Change From Baseline in Leptin		Baseline, Week 24