ObesityPhase 2NCT05925114
Safety and Efficacy Study of S-309309 in Obese Adults
A Phase 2 study testing S-309309 in people with Obesity, run by Shionogi at 49 sites in United States.
Trial summary
The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- S-309309
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 49 sitesUnited States
- Study dates
- 21 Jun 2023to 17 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 38Show fewer
- 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.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
AES - DRS - Synexus Clinical Research US, Inc.
Akron, Ohio, 44311-1012
Annapolis Internal Medicine, LLC
Annapolis, Maryland, 21401-7050
Flourish Research - Birmingham - PPDS
Birmingham, Alabama, 35205-1605
Synexus Clinical Research
Birmingham, Alabama, 35211-1320
Boston Clinical Trials Inc. - Alcanza - HyperCore - PPDS
Boston, Massachusetts, 02131-2515
Tryon Medical Practice - Ballantyne - Javara - PPDS
Charlotte, North Carolina, 28287-3884
Charlottesville Medical Research Center
Charlottesville, Virginia, 22911-3589
Flourish Research - Ravenswood - PPDS
Chicago, Illinois, 60640-7927
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
Cincinnati, Ohio, 45219-2975
Endocrine Consultants Research - Columbus - Centricity Research - HyperCore - PPDS
Columbus, Georgia, 31904-4501
Dallas Diabetes Research Center
Dallas, Texas, 75230-6885
Medical Care, LLC
Elizabethton, Tennessee, 47643-2654
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
Fayetteville, Georgia, 302140-1578
Hatboro Medical Associates PC
Hatboro, Pennsylvania, 19040-2024
A G A Clininical Trials- HyperCore PPDS
Hialeah, Florida, 33012-3407
Lucas Research - Hickory - HyperCore - PPDS
Hickory, North Carolina, 28601-3829
Helios CR Ins Houston - PPDS
Houston, Texas, 77008-1366
Juno Research LLC
Houston, Texas, 77040-5063
Juno Research LLC
Houston, Texas, 77054
Edrocrine and Psychiatry Center
Houston, Texas, 77095-2856
Westside Center for Clinical Research - ERN - PPDS
Jacksonville, Florida, 32205-4785
Helios CR, Inc. - Keller - PPDS
Keller, Texas, 76248-4235
Vytalus Medical Group
Kingwood, Texas, 77339
3Sync, LLC
Lake Worth, Florida, 33460-4400
Palm Research Center, Inc
Las Vegas, Nevada, 89148-5613
Lifeline Primary Care - CCT-PPDS
Lilburn, Georgia, 30047
Be Well Clinical Studies LLC
Lincoln, Nebraska, 68516
National Research Institute - ClinEdge - PPDS
Los Angeles, California, 90057-3550
L MARC Research Center
Louisville, Kentucky, 40213-1014
Manasas Clinical Research Center
Manassas, Virginia, 20110
ActivMed Practices & Research, Inc. - Portsmouth - Alcanza - HyperCore - PPDS
Methuen, Massachusetts, 01844
Suncoast Research Group LLC - Flourish - PPDS
Miami, Florida, 33135-1687
Angels Clinical Research Institute-Miami
Miami Lakes, Florida, 33016-1598
Catalina Research Institute
Montclair, California, 91763-2231
AES - DRS - Synexus Clinical Research US, Inc
Murray, Utah, 84123-2967
Lynn Institute of East Oklahoma - ERN PPDS
Oklahoma City, Oklahoma, 73104-5033
Oviedo Medical Research - ClinEdge PPDs
Oviedo, Florida, 32765-4515
Foothills Research Center - CCT - PPDS
Phoenix, Arizona, 85044-6097
Ogden Clinic - Grand View
Roy, Utah, 84067-9438
Northern California Research Corp
Sacramento, California, 95821-2640
Olympus Family Medicine - CCT - PPDS
Salt Lake City, Utah, 84117
Flourish Research
San Antonio, Texas, 78229-3539
Diabetes and Gandular Disease Clinic, PA
San Antonio, Texas, 78229-4801
Consano Clinical Research
San Antonio, Texas, 78258-3916
Privia Medical Group Mid-Atlantic - Javara - PPDS
Silver Spring, Maryland, 20901-4402
South Ogden Family Medicine
South Ogden, Utah, 84405
Encompass Clinical Research - ClinEdge - PPDS
Spring Valley, California, 91978-1522
Precision Clinical Research
Sunrise, Florida, 333351-7311
Chase Medical Research LLC
Waterbury, Connecticut, 06708-3346
About this study
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
The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.
- Conditions
- Obesity
- Being tested
- S-309309, Placebo
- Keywords
- Body Weight, Waist, Body Mass Index (BMI)
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-309309Drug
Administered as oral capsules
PlaceboDrug
Administered as an oral capsule that looks identical to S-309309 capsule
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1: S-309309 | Experimental | Participants will receive S-309309 (low dose) once daily for 24 weeks Receives: Drug: S-309309 |
| Dose Level 2: S-309309 | Experimental | Participants will receive S-309309 (middle dose) once daily for 24 weeks Receives: Drug: S-309309 |
| Dose Level 3: S-309309 | Experimental | Participants will receive S-309309 (high dose) once daily for 24 weeks Receives: Drug: S-309309 |
| Placebo | Placebo comparator | Participants will receive placebo once daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight
Measured: Baseline, Week 24
Secondary outcomes (17)
Percentage of Participants Achieving a Weight Loss of ≥ 5%
Measured: Baseline to Week 24
Percentage of Participants Achieving a Weight Loss of ≥ 10%
Measured: Baseline to Week 24
Percentage of Participants Achieving a Weight Loss of ≥ 15%
Measured: Baseline to Week 24
Percentage of Participants Achieving a Weight Loss of ≥ 20%
Measured: Baseline to Week 24
Change From Baseline in Waist Circumference
Measured: Baseline, Week 24
Change From Baseline in Hip/Waist Ratio
Measured: Baseline, Week 24
Change From Baseline in BMI
Measured: Baseline, Week 24
Change From Baseline in Glucose Metabolism Parameters as Assessed by Hemoglobin A1c or Glycosylated Hemoglobin (HbA1c)
Measured: Baseline, Week 24
Change From Baseline in Glucose Metabolism Parameters as Assessed by Fasting Plasma Glucose (FPG)
Measured: Baseline, Week 24
Change From Baseline in Cardiovascular Risk Factors
Measured: Baseline, Week 24
Change From Baseline in Body Composition: Total Fat Mass as Assessed by DEXA scan
Measured: Baseline, Week 24
Change From Baseline in Body Composition: Lean Mass as Assessed by DEXA scan
Measured: Baseline, Week 24
Change From Baseline in Body Composition: Visceral Fat Mass as Assessed by DEXA scan
Measured: Baseline, Week 24
Plasma Concentration of S-309309
Measured: Up to 24 weeks
Change From Baseline in Adiponectin
Measured: Baseline, Week 24
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Measured: Baseline, Week 24
Change From Baseline in Leptin
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start21 Jun 2023
- Primary completion15 Apr 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925114
- Sponsor's protocol ID
- 2201N1121
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05925114
- Acronym / sponsor ID
- 2201N1121
- Conditions
- Obesity
- Keywords
- Body Weight, Waist, Body Mass Index (BMI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: S-309309 | Experimental | Drug: S-309309Participants will receive S-309309 (low dose) once daily for 24 weeks |
| Dose Level 2: S-309309 | Experimental | Drug: S-309309Participants will receive S-309309 (middle dose) once daily for 24 weeks |
| Dose Level 3: S-309309 | Experimental | Drug: S-309309Participants will receive S-309309 (high dose) once daily for 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo once daily for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-309309Administered as oral capsules | Drug | Dose Level 1: S-309309, Dose Level 2: S-309309, Dose Level 3: S-309309 |
| PlaceboAdministered as an oral capsule that looks identical to S-309309 capsule | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 24
17 secondary outcomes
Percentage of Participants Achieving a Weight Loss of ≥ 5%
Time frame: Baseline to Week 24
Percentage of Participants Achieving a Weight Loss of ≥ 10%
Time frame: Baseline to Week 24
Percentage of Participants Achieving a Weight Loss of ≥ 15%
Time frame: Baseline to Week 24
Percentage of Participants Achieving a Weight Loss of ≥ 20%
Time frame: Baseline to Week 24
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 24
Change From Baseline in Hip/Waist Ratio
Time frame: Baseline, Week 24
Change From Baseline in BMI
Time frame: Baseline, Week 24
Change From Baseline in Glucose Metabolism Parameters as Assessed by Hemoglobin A1c or Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, Week 24
Change From Baseline in Glucose Metabolism Parameters as Assessed by Fasting Plasma Glucose (FPG)
Time frame: Baseline, Week 24
Change From Baseline in Cardiovascular Risk Factors
Time frame: Baseline, Week 24
Change From Baseline in Body Composition: Total Fat Mass as Assessed by DEXA scan
Time frame: Baseline, Week 24
Change From Baseline in Body Composition: Lean Mass as Assessed by DEXA scan
Time frame: Baseline, Week 24
Change From Baseline in Body Composition: Visceral Fat Mass as Assessed by DEXA scan
Time frame: Baseline, Week 24
Plasma Concentration of S-309309
Time frame: Up to 24 weeks
Change From Baseline in Adiponectin
Time frame: Baseline, Week 24
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, Week 24
Change From Baseline in Leptin
Time frame: Baseline, Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Shionogi
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-309309 in people with Obesity, run by Shionogi at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.