ObesityPhase 1NCT05247970
A Study to Assess S-309309 in Healthy and Obese Participants
A Phase 1 study testing S-309309 and Midazolam in people with Obesity, run by Shionogi at 1 site in United States.
Trial summary
The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- S-309309 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 1 Nov 2022
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG at the Screening Visit and upon admission to the clinical research unit (CRU).
- Body weight ≥50 kilograms (kg), and body mass index (BMI) within the range ≥18.5 to <30.0 kilogram/meter square (kg/m^2) for all groups except Group G-2. For Group G-2, BMI ≥ 30 to < 40 kg/m2 at the Screening Visit.
Who cannot join
- History or presence of/significant 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.
- Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Unable to swallow capsules.
- Chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: A Phase 1 Randomized, Double-blind, Single and Multiple-dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of S-309309 in Healthy and Obese Adult Study Participants
The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.
Read the detailed description
This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group.
Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-309309Drug
Capsule administered orally
MidazolamDrug
Syrup administered orally
PlaceboDrug
Matching capsule to S-309309 administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1: S-309309 | Experimental | Participants will receive S-309309 at specific timepoints in a fasted state. Receives: Drug: S-309309 |
| Part 2: S-309309 and Midazolam | Experimental | Participants will receive S-309309 and Midazolam at specific timepoints fed state. Receives: Drug: S-309309; Drug: Midazolam |
| Part 1 and 2: Placebo | Placebo comparator | Participants will receive a matching placebo to S-309309 at specific timepoints in either a fed or fasted state. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Day 28
Secondary outcomes (25)
Part 1: Maximum Plasma Concentration (Cmax) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Time to Maximum Plasma Concentration (Tmax) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Terminal Elimination Half-Life (t1/2,z) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Terminal Elimination Rate Constant (λz) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Mean Residence Time (MRT) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Apparent Total Clearance (CL/F) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Apparent Volume of Distribution (Vz/F) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Renal Clearance (CLR) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Fraction of Dose Excreted in Urine (Feu) of S-309309
Measured: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Change From Baseline of Electrocardiogram (ECG) Parameters: QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), Pulse Rate (PR) Interval, and Combination of the Q, R, and S Waves (QRS) Duration
Measured: Baseline, Day 2, 5, 7 and 16
Part 1: Change From Baseline of ECG Parameter: Heart Rate (HR)
Measured: Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Part 1: Placebo-Corrected Change From Baseline of ECG Parameters: QTcF, PR Interval, and QRS Duration
Measured: Baseline, Day 2, 5, 7 and 16
Part 1: Placebo-Corrected Change From Baseline of ECG Parameter: HR
Measured: Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Part 1: Number of Participants With Categorical Outlier Values for HR, QTcF, PR, and QRS
Measured: Baseline up to Day 16
Part 1: Number of Participants With Treatment-Emergent Changes for T-wave Morphology and Presence of U-wave
Measured: Baseline up to Day 16
Part 2: Cmax of S-309309 and Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: Tmax of S-309309 and Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: AUC of S-309309 and Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: t1/2,z of S-309309 and Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: λz of S-309309 and Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: CL/F of S-309309 and Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: Vz/F of S-309309 and Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: MRT of Midazolam
Measured: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: Number of Participants with TEAEs After Coadministration with Midazolam
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start4 Jan 2022
- Primary completion20 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247970
- Sponsor's protocol ID
- 2018N1111
- Status last verified
- Jan 2023
- First submitted
- 8 Feb 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ishibashi T, Tanioka H, Ikehara T, Kezbor S, Sonoyama T. Safety, Tolerability, and Pharmacokinetics of a Novel Anti-obesity Agent, S-309309, in Healthy Adults with or Without Obesity. Clin Drug Investig. 2025 Feb;45(2):85-99. doi: 10.1007/s40261-024-01418-3. Epub 2025 Jan 20.
PubMed 39832041
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Single and Multiple-dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of S-309309 in Healthy and Obese Adult Study Participants
- ClinicalTrials.gov ID
- NCT05247970
- Acronym / sponsor ID
- 2018N1111
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 21 Feb 2022 (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 aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.
Detailed description
This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group.
Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: S-309309 | Experimental | Drug: S-309309Participants will receive S-309309 at specific timepoints in a fasted state. |
| Part 2: S-309309 and Midazolam | Experimental | Drug: S-309309, Drug: MidazolamParticipants will receive S-309309 and Midazolam at specific timepoints fed state. |
| Part 1 and 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a matching placebo to S-309309 at specific timepoints in either a fed or fasted state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG at the Screening Visit and upon admission to the clinical research unit (CRU).
- Body weight ≥50 kilograms (kg), and body mass index (BMI) within the range ≥18.5 to <30.0 kilogram/meter square (kg/m^2) for all groups except Group G-2. For Group G-2, BMI ≥ 30 to < 40 kg/m2 at the Screening Visit.
Key exclusion criteria (5 listed)
- History or presence of/significant 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.
- Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Unable to swallow capsules.
- Chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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-309309Capsule administered orally | Drug | Part 1: S-309309, Part 2: S-309309 and Midazolam |
| MidazolamSyrup administered orally | Drug | Part 2: S-309309 and Midazolam |
| PlaceboMatching capsule to S-309309 administered orally | Drug | Part 1 and 2: Placebo |
Primary outcome
Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 28
25 secondary outcomes
Part 1: Maximum Plasma Concentration (Cmax) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Time to Maximum Plasma Concentration (Tmax) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Terminal Elimination Half-Life (t1/2,z) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Terminal Elimination Rate Constant (λz) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Mean Residence Time (MRT) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Apparent Total Clearance (CL/F) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Apparent Volume of Distribution (Vz/F) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Renal Clearance (CLR) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Fraction of Dose Excreted in Urine (Feu) of S-309309
Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21
Part 1: Change From Baseline of Electrocardiogram (ECG) Parameters: QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), Pulse Rate (PR) Interval, and Combination of the Q, R, and S Waves (QRS) Duration
Time frame: Baseline, Day 2, 5, 7 and 16
Part 1: Change From Baseline of ECG Parameter: Heart Rate (HR)
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Part 1: Placebo-Corrected Change From Baseline of ECG Parameters: QTcF, PR Interval, and QRS Duration
Time frame: Baseline, Day 2, 5, 7 and 16
Part 1: Placebo-Corrected Change From Baseline of ECG Parameter: HR
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7 and 16
Part 1: Number of Participants With Categorical Outlier Values for HR, QTcF, PR, and QRS
Time frame: Baseline up to Day 16
Part 1: Number of Participants With Treatment-Emergent Changes for T-wave Morphology and Presence of U-wave
Time frame: Baseline up to Day 16
Part 2: Cmax of S-309309 and Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: Tmax of S-309309 and Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: AUC of S-309309 and Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: t1/2,z of S-309309 and Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: λz of S-309309 and Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: CL/F of S-309309 and Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: Vz/F of S-309309 and Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: MRT of Midazolam
Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Part 2: Number of Participants with TEAEs After Coadministration with Midazolam
Time frame: Up to Day 28
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 11 Jan 2023.
- Derived from this study: PubMed 39832041Ishibashi T, Tanioka H, Ikehara T, Kezbor S, Sonoyama T. Safety, Tolerability, and Pharmacokinetics of a Novel Anti-obesity Agent, S-309309, in Healthy Adults with or Without Obesity. Clin Drug Investig. 2025 Feb;45(2):85-99. doi: 10.1007/s40261-024-01418-3. Epub 2025 Jan 20.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-309309 and Midazolam in people with Obesity, run by Shionogi at 1 site 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 2 inclusion and 5 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247970, which also lists 1 linked publication.
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 11 Jan 2023.