Safety and Efficacy Study of S-309309 in Obese Adults

NCT05925114 | Completed Phase 2 FDA Drug

• 1 other identifier: 2201N1121
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 49

Brief Summary

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

Conditions

Obesity

Keywords

Body Weight; Waist; Body Mass Index (BMI)

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Weight

  Baseline, Week 24

Secondary Outcomes (17)

• 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

Study Arms (4)

Dose Level 1: S-309309

EXPERIMENTAL

Participants will receive S-309309 (low dose) once daily for 24 weeks

Drug: S-309309

Dose Level 2: S-309309

EXPERIMENTAL

Participants will receive S-309309 (middle dose) once daily for 24 weeks

Drug: S-309309

Dose Level 3: S-309309

EXPERIMENTAL

Participants will receive S-309309 (high dose) once daily for 24 weeks

Drug: S-309309

Placebo

PLACEBO COMPARATOR

Participants will receive placebo once daily for 24 weeks

Drug: Placebo

Interventions

S-309309 DRUG

Administered as oral capsules

Dose Level 1: S-309309; Dose Level 2: S-309309; Dose Level 3: S-309309

Placebo DRUG

Administered as an oral capsule that looks identical to S-309309 capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (49)

Flourish Research - Birmingham - PPDS

Birmingham, Alabama, 35205-1605, United States

Location

Synexus Clinical Research

Birmingham, Alabama, 35211-1320, United States

Location

Foothills Research Center - CCT - PPDS

Phoenix, Arizona, 85044-6097, United States

Location

National Research Institute - ClinEdge - PPDS

Los Angeles, California, 90057-3550, United States

Location

Catalina Research Institute

Montclair, California, 91763-2231, United States

Location

Northern California Research Corp

Sacramento, California, 95821-2640, United States

Location

Encompass Clinical Research - ClinEdge - PPDS

Spring Valley, California, 91978-1522, United States

Location

Chase Medical Research LLC

Waterbury, Connecticut, 06708-3346, United States

Location

A G A Clininical Trials- HyperCore PPDS

Hialeah, Florida, 33012-3407, United States

Location

Westside Center for Clinical Research - ERN - PPDS

Jacksonville, Florida, 32205-4785, United States

Location

3Sync, LLC

Lake Worth, Florida, 33460-4400, United States

Location

Suncoast Research Group LLC - Flourish - PPDS

Miami, Florida, 33135-1687, United States

Location

Angels Clinical Research Institute-Miami

Miami Lakes, Florida, 33016-1598, United States

Location

Oviedo Medical Research - ClinEdge PPDs

Oviedo, Florida, 32765-4515, United States

Location

Precision Clinical Research

Sunrise, Florida, 333351-7311, United States

Location

Endocrine Consultants Research - Columbus - Centricity Research - HyperCore - PPDS

Columbus, Georgia, 31904-4501, United States

Location

Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS

Fayetteville, Georgia, 302140-1578, United States

Location

Lifeline Primary Care - CCT-PPDS

Lilburn, Georgia, 30047, United States

Location

Flourish Research - Ravenswood - PPDS

Chicago, Illinois, 60640-7927, United States

Location

L MARC Research Center

Louisville, Kentucky, 40213-1014, United States

Location

Annapolis Internal Medicine, LLC

Annapolis, Maryland, 21401-7050, United States

Location

Privia Medical Group Mid-Atlantic - Javara - PPDS

Silver Spring, Maryland, 20901-4402, United States

Location

Boston Clinical Trials Inc. - Alcanza - HyperCore - PPDS

Boston, Massachusetts, 02131-2515, United States

Location

ActivMed Practices & Research, Inc. - Portsmouth - Alcanza - HyperCore - PPDS

Methuen, Massachusetts, 01844, United States

Location

Be Well Clinical Studies LLC

Lincoln, Nebraska, 68516, United States

Location

Palm Research Center, Inc

Las Vegas, Nevada, 89148-5613, United States

Location

Tryon Medical Practice - Ballantyne - Javara - PPDS

Charlotte, North Carolina, 28287-3884, United States

Location

Lucas Research - Hickory - HyperCore - PPDS

Hickory, North Carolina, 28601-3829, United States

Location

AES - DRS - Synexus Clinical Research US, Inc.

Akron, Ohio, 44311-1012, United States

Location

Velocity Clinical Research (Cincinnati - Ohio) - PPDS

Cincinnati, Ohio, 45219-2975, United States

Location

Lynn Institute of East Oklahoma - ERN PPDS

Oklahoma City, Oklahoma, 73104-5033, United States

Location

Hatboro Medical Associates PC

Hatboro, Pennsylvania, 19040-2024, United States

Location

Medical Care, LLC

Elizabethton, Tennessee, 47643-2654, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230-6885, United States

Location

Helios CR Ins Houston - PPDS

Houston, Texas, 77008-1366, United States

Location

Juno Research LLC

Houston, Texas, 77040-5063, United States

Location

Juno Research LLC

Houston, Texas, 77054, United States

Location

Edrocrine and Psychiatry Center

Houston, Texas, 77095-2856, United States

Location

Helios CR, Inc. - Keller - PPDS

Keller, Texas, 76248-4235, United States

Location

Vytalus Medical Group

Kingwood, Texas, 77339, United States

Location

Flourish Research

San Antonio, Texas, 78229-3539, United States

Location

Diabetes and Gandular Disease Clinic, PA

San Antonio, Texas, 78229-4801, United States

Location

Consano Clinical Research

San Antonio, Texas, 78258-3916, United States

Location

AES - DRS - Synexus Clinical Research US, Inc

Murray, Utah, 84123-2967, United States

Location

Ogden Clinic - Grand View

Roy, Utah, 84067-9438, United States

Location

Olympus Family Medicine - CCT - PPDS

Salt Lake City, Utah, 84117, United States

Location

South Ogden Family Medicine

South Ogden, Utah, 84405, United States

Location

Charlottesville Medical Research Center

Charlottesville, Virginia, 22911-3589, United States

Location

Manasas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

MeSH Terms

Conditions

Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: June 21, 2023
• Primary Completion: April 15, 2024
• Study Completion: May 17, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (49)