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Not yet recruitingNCT07889505Updated Oct 22, 2026

A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes

A Phase 2 interventional study of PS1 and Placebo in Type 1 Diabetes Mellitus, sponsored by Pharmasaga Co. Ltd.. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Pharmasaga Co. Ltd. · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study consists of 2 sub-studies, including Part A and Part B. Part A is intended to further characterize the pharmacokinetic (PK) profile of PS1 based on existing single ascending dose (SAD) and multiple ascending dose (MAD) data, while Part B is designed as an exploratory study to evaluate the potential clinical effects of PS1 in adults with newly diagnosed type 1 diabetes mellitus (T1DM). PS1 is a potential blood glucose-lowering medication being developed by Pharmasaga Co., Ltd. for the treatment of T1DM.

Read the detailed description

Part A This is an open-label, parallel-group sub-study to characterize the PK characteristics, and determine the safety, and tolerability of PS1 via oral administration in healthy volunteers.

Approximately 12 eligible participants will receive a single dose of PS1 in Part A, with 6 participants receiving 25 mg and 6 participants receiving 50 mg.

Part A will consist of a screening period (Visit 1; Days -28 to -2), predose assessments visit (Visit 2; Day-1), a treatment period (Visit 3; Day 1, Day 2), and a post-treatment observation visit on Day 8 (Visit 4). Participants may be hospitalized overnight, at the discretion of the investigator/site, to facilitate the conduct of scheduled Day -1 and Day 1/Day 2 study procedures and receive single dose of PS1 on Day 1 (Visit 3) and may continue to be hospitalized for PK sample collection till Day 2.

Blood plasma samples will be collected at following timepoints: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing. The participant will be discharged immediately (if hospitalized) after the 24-hour PK sample collection time point on Day 2. On Day 8, the participant will come for post-treatment observation visit and an additional PK sample will be collected on the same day, which will be the end of study (EOS) for participant.

The decision to proceed to Part B will be made after all participants in Part A have completed dosing and the planned safety follow-up period.

Part B This is a randomized, double-blind, placebo-controlled sub-study to evaluate the efficacy, safety, and PK characteristics of PS1 via oral administration in combination with standard of care (SOC) for adults diagnosed with T1D within ≤12 months.

Part B consists of a screening period (Weeks -4 to -1; followed by a predose assessments visit [Visit 2; Day-1]), a treatment period (Weeks 1 to 12), and a post-treatment observation period (Weeks 13 to 16).

During the treatment period, approximately 24 eligible participants will be randomly assigned in a 1:1:1 ratio to either the 50 mg treatment group (PS1 + SOC, N = 8), 25 mg treatment group (PS1 + SOC, N = 8), or control group (placebo + SOC, N = 8). Each participant will receive either PS1 at a dose of 50 mg QD, PS1 at a dose of 25 mg QD, or placebo QD, for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment. All participants will receive SOC for T1D for the entire sub-study period (treatment period + post treatment observation period). Participants may be hospitalized overnight, at the discretion of the investigator/site, to facilitate the conduct of scheduled Day -1 and Day 1/Day 2 study procedures. A participant will receive first dose of study treatment on Day 1 (Visit 3) and may continue to be hospitalized for PK sample collection till Day 2. All participants will receive standard management of their diabetes (SOC) during the entire study period including the treatment period and post-treatment observation period.

The study will be maintained as blinded, and an independent Data Monitoring Committee (DMC) will be established by the sponsor to review accumulating safety data.

02

Conditions studied

  • Type 1 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's planned enrollment of 36 is close to the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Pharmasaga Co. Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Part A

    • Male or female non-Asian participants aged 18 to 60 years, inclusive at screening.
    • BMI between 18 and 32 kg/m2.
    • Overtly healthy participant, who is considered to be generally healthy based on medical history, vital signs, laboratory tests, 12 lead ECG, and physical examination, as judged by the investigator.
    • With HbA1c value of \<6.5% and fasting plasma glucose \<110 mg/dL at screening.
    • With estimated glomerular filtration rate (eGFR) >80 mL/min/1.73 m² (according to a chronic kidney disease epidemiology collaboration equation [CKD-EPI] 2021 creatinine equation for adults).

  • Part B

    • Male or female participants aged 18 to 50 years, inclusive, at the time of signing the informed consent form (ICF).
    • Participants have received a diagnosis of T1D within ≤12 months according to American Diabetes Association (ADA) criteria at the time of screening.
    • Documented treatment with stable exogenous insulin therapy for a minimum of 14 consecutive days prior to randomization.
    • Evidence of residual endogenous β-cell function, defined as a peak stimulated C-peptide of ≥0.2 pmol/mL from a standardized 2-hour MMTT at screening.
    • Participants have a positive result on testing for at least 1 of the T1D-related autoantibodies before randomization (results from a local laboratory are acceptable).
    • Participants are able to comply with the SOC of T1D management and all protocol procedures for the duration of the study.

  • Part A and Part B

    • Negative test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), anti-hepatitis C virus (HCV) antibody, and human immunodeficiency virus at screening. Participants with positive anti-HCV may be enrolled only if they have a negative HCV RNA result during the screening period.
    • Female participants of childbearing potential must have a negative result on a highly sensitive serum (β human chorionic gonadotropin) test at screening.
    • Participants agree not to receive other forms of experimental treatment during the study, particularly agents that may be immune modulatory in nature and/or stimulate pancreatic β cell regeneration or insulin secretion.

Exclusion criteria

Exclusion Criteria:

  • Part A

    • History of type I or type II diabetes mellitus.
    • Participants who are receiving systemic treatment with any prescription or over-the-counter medication that, in the investigator's judgment, may interfere with safety or PK assessments within 7 days before dosing.
    • Participants who have received a strong CYP enzyme inhibitor or inducer within 14 days before dosing.
    • Received any vaccination within 2 weeks or live or attenuated vaccines within 4 weeks before screening.
    • Known hypersensitivity to any of the components of PS1 tablet.
    • History of pancreatitis.
    • History of major clinically significant hematologic, renal, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, musculoskeletal, immune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within 3 months of screening that may significantly alter the biomarker panel, require receiving any systemic medications, or interfere with the interpretation of data, as judged by the investigator.
    • Serum amylase >1.5 × ULN or lipase >1.5 × ULN, at screening.
    • Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN, or total bilirubin >1.5 × ULN (except in participants with Gilbert's syndrome), at screening.
    • Clinically significant ECG abnormality at screening.
    • Took glucose-lowering medications within the last 2 weeks prior to screening
    • Received any investigational therapy from another clinical study within the last 12 weeks prior to screening.
    • Received any systemic steroids (inhaled and intranasal steroids are permitted) or other immunosuppressive medications within 4 weeks prior to dosing.
    • Underwent any major surgery within 12 weeks or any non-major surgeries within 4 weeks prior to dosing

  • Part B

    • Have known allergies, severe reactions, intolerance, hypersensitivity, or anaphylaxis to PS1 or any of its components or its excipients
    • Have been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical study within 30 days or 5 half lives (whichever is longer) before the first dose of the study drug or have received an investigational treatment with the potential for T1D disease modification
    • Have an HbA1c ≥10%
    • Have experienced 1 or more episodes of DKA within 30 days prior to randomization or have had 1 or more emergency room visits or hospitalizations due to poor glucose control (severe hyperglycemia or hypoglycemic episodes) within 1 month prior to randomization.
    • Have a history of acute or chronic pancreatitis
    • Have a serum triglyceride level >500 mg/dL (5.6 mmol/L) at screening
    • Have a serum lipase or amylase level >1.5 × ULN at screening
    • Have eating disorders or any gastrointestinal problems that might, in the opinion of the investigator, impact/confound the results of the study or interfere with the participant's ability to comply with the study procedures.
    • Have a known malignancy, with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma.
    • Have a diagnosis of sickle cell disease or other hemoglobinopathies that may interfere with interpretation of HbA1c or glycemic endpoints.
    • Have a diagnosis of significant liver disease at screening, or ALT and/or AST >2 × or total bilirubin >1.5 × the age- and sex-specific ULN (Note: Participants with Gilbert's syndrome may be allowed to enroll upon approval by the medical monitor).

    • Have any of the following hematologic parameters, confirmed by repeat tests, within 10 days before randomization or the first dose of the study drug:

      • Lymphocyte count: \<500/μL
      • Neutrophil count: \<1500/μL
      • Platelet count: \<100,000/μL
      • Hemoglobin: \<10 g/dL
    • Have impaired renal function, defined by an eGFR (according to CKD-EPI 2021 creatinine equation) of \<60 mL/min/1.73 m2.
    • Have received current or prior (within 30 days before screening) treatment that is known to cause a significant ongoing change in the course of T1D or immunologic status, including high dose inhaled, extensive topical, or systemic glucocorticoids. (Note: Short courses, ie, approximately 2 weeks or less, of corticosteroids for transient conditions are allowed).
    • Have current or prior (within 30 days before screening) use of drugs other than insulin to treat hyperglycemia (eg, metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dipeptidyl peptidase-4 inhibitors, or amylin).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Part A - SAD - 25mg

    An eligible healthy subject will receive a single dose of 25 mg of PS1 on Day 1 and be followed for 7 days.

    Drug: PS1

  • Experimental
    Part A - SAD - 50mg

    An eligible healthy subject will receive a single dose of 50 mg of PS1 on Day 1 and be followed for 7 days.

    Drug: PS1

  • Experimental
    Part B - 25mg

    An eligible subject will receive one 25 mg PS1 and one PS1 matching (placebo) tablet once daily for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment.

    Drug: PS1 · Drug: Placebo

  • Experimental
    Part B - 50mg

    An eligible subject will receive two 25 mg PS1 tablets once daily for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment.

    Drug: PS1

  • Placebo comparator
    Part B - placebo

    An eligible subject will receive two PS1-matching (placebo) tablets once daily for 12 weeks (approximately 3 months) in a blind manner, and will be followed up to 16 weeks (approximately 4 months) from the start of the treatment.

    Drug: Placebo

Interventions

  • DrugPS1

    PS1 will be provided as a 120 mg tablet with 25 mg active pharmaceutical ingredient.

  • DrugPlacebo

    Placebo will be provided as a 120 mg tablet.

06

What researchers measure

Primary outcomes

  1. Part B: Change from Baseline in 4-Hour Mixed-Meal Tolerance Test (MMTT)-Stimulated C-Peptide Area Under the Curve (AUC)

    To evaluate the effect of PS1 compared with placebo on 4-hour MMTT-stimulated C-peptide AUC from baseline to Week 12 in adults with newly diagnosed type 1 diabetes (T1D) (≤12 months since diagnosis).

    Time frame: Part B: Approximately 4 months.

  2. Part A: Pharmacokinetics (PK) of PS1

    AUC\_Area under the serum concentration-time profile

    Time frame: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.

  3. Part A: Pharmacokinetics (PK) of PS1

    Cmax\_The peak post-dose concentration

    Time frame: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.

  4. Part A: Pharmacokinetics (PK) of PS1

    Tmax\_Time at which Cmax is observed

    Time frame: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.

  5. Part A: Pharmacokinetics (PK) of PS1

    T1/2\_Terminal phase elimination half-life

    Time frame: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.

  6. Part A: Pharmacokinetics (PK) of PS1

    MRT\_Mean Residence Time

    Time frame: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.

  7. Part A: Pharmacokinetics (PK) of PS1

    CL/F\_Apparent Clearance

    Time frame: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.

  8. Part A: Pharmacokinetics (PK) of PS1

    Vd/F\_Apparent volume of distribution

    Time frame: Day 1-2: predose, and 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing & Day 8.

Secondary outcomes

  1. Part A & Part B: Incidence and severity (per Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0) of treatment-emergent adverse events (TEAEs) including hypoglycemia, serious adverse events (SAEs)

    All adverse events (AEs) will be assessed for severity by the investigator based on NCI-CTCAE v5.0

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  2. Part A & Part B: Abnormalities in Physical examination

    Participants with abnormal Physical examination findings

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  3. Part A & Part B: Abnormalities in 12-lead electrocardiogram (ECG) results

    12-lead electrocardiogram (EKG) (PR interval, QRS interval, and QT interval will be recorded. \[Unit: msec\])

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  4. Part A & Part B: Abnormalities in 12-lead electrocardiogram (ECG) results

    12-lead electrocardiogram (EKG) (Ventricular rate will be recorded. \[Unit: beats/min\])

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  5. Part A & Part B: Abnormalities in vital signs

    Vital signs (Systolic Blood Pressure \& Diastolic Blood Pressure)(Unit: mmHg)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  6. Part A & Part B: Abnormalities in vital signs

    Vital signs (Pulse rate) (Unit: beats/min)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  7. Part A & Part B: Abnormalities in vital signs

    Vital signs (Respiratory Rate) (Unit: breaths/min)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  8. Part A & Part B: Abnormalities in vital signs

    Vital signs (Temperature) (Unit: Celsius)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  9. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Hematology physiological parameter tests results (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) (Unit: g/dL)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  10. Part B: Pharmacokinetics (PK) of PS1

    Vd/F\_Apparent volume of distribution

    Time frame: Part B: Approximately 5 months.

  11. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Hematology physiological parameter tests results (hematocrit, HbA1c and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) (Unit: %)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  12. Part B: Pharmacokinetics (PK) of PS1

    CL/F\_Apparent Clearance

    Time frame: Part B: Approximately 5 months.

  13. Part B: Pharmacokinetics (PK) of PS1

    MRT\_Mean Residence Time

    Time frame: Part B: Approximately 5 months.

  14. Part B: Pharmacokinetics (PK) of PS1

    T1/2\_Terminal phase elimination half-life

    Time frame: Part B: Approximately 5 months.

  15. Part B: Pharmacokinetics (PK) of PS1

    Tmax\_Time at which Cmax is observed

    Time frame: Part B: Approximately 5 months.

  16. Part B: Pharmacokinetics (PK) of PS1

    Cmax\_The peak post-dose concentration

    Time frame: Part B: Approximately 5 months.

  17. Part B: Pharmacokinetics (PK) of PS1

    AUC\_Area under the serum concentration-time profile

    Time frame: Part B: Approximately 5 months.

  18. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Hematology physiological parameter tests results (RBC) (Unit: 10\^6/uL)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  19. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Hematology physiological parameter tests results (platelet and WBC) (Unit: 10\^3/uL)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  20. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular volume, MCV) (Unit: fL)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  21. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular hemoglobin, MCH) (Unit: pg)

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  22. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Biochemistry physiological parameter tests results

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  23. Part A & Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Urinalysis physiological parameter tests results

    Time frame: Part A SAD: Approximately 5 weeks. Part B: Approximately 5 months.

  24. Part B: Pharmacokinetics (PK) of PS1

    Rac\_Accumulation ratio

    Time frame: Part B: Approximately 5 months.

  25. Part B: Abnormalities in clinical laboratory examination

    Participants with abnormal laboratory - Clinically important hypoglycemic episodes, defined as the total number of episodes of a blood glucose (BG) reading of \<54 mg/dL (3.0 mmol/L), episodes of severe cognitive impairment, and/or physical status requiring external assistance for recovery. Incidence of typical hypoglycemia, defined as BG levels ≥54 mg/dL (3.0 mmol/L) but \<70 mg/dL (3.9 mmol/L) and/or non-severe clinical episodes

    Time frame: Part B: Approximately 4 months.

  26. Part B: Abnormalities in clinical laboratory examination

    Participants with incidence of DKA requiring medical attention, defined as a hyperglycemic episode (BG ≥250 mg/dL \[13.9 mmol/L\]) with serum or urine ketones elevated beyond the upper limit of normal (ULN), along with serum bicarbonate \<15 mmol/L, blood pH \<7.3, or both, resulting in an outpatient or emergency room visit, or hospitalization

    Time frame: Part B: Approximately 4 months.

  27. Part B: 4-Hour Mixed-Meal Tolerance Test (MMTT)-Stimulated C-Peptide Area Under the Curve (AUC) at Week 12

    The area under the C-peptide concentration-time curve during the 4-hour MMTT, calculated using the protocol-specified method

    Time frame: Part B: Approximately 4 months.

  28. Part B: To evaluate the effects of PS1 on glycemic control of hemoglobin A1c [HbA1c]

    HbA1c level (percentage and mmol/mol)

    Time frame: Part B: Approximately 4 months.

  29. Part B: To evaluate the effects of PS1 on postprandial metabolic responses

    Assessed by glucagon and glucose concentrations and the C-peptide/glucose ratio over 4 hours after the mixed meal tolerance test (MMTT)

    Time frame: Part B: Approximately 4 months.

  30. Part B: To evaluate the effects of PS1 on key clinical parameters of diabetes management

    Exogenous insulin use and insulin dose-adjusted HbA1c (IDAA1c)

    Time frame: Part B: Approximately 4 months.

  31. Part B: Peak MMTT-Stimulated C-Peptide Concentration at Week 12

    The maximum C-peptide concentration measured during the MMTT, based on the protocol-specified sampling time points

    Time frame: Part B: Approximately 4 months.

  32. Part B: MMTT-Stimulated C-Peptide Concentration at 90 Minutes at Week 12

    C-peptide concentration measured 90 minutes after initiation of the MMTT.

    Time frame: Part B: Approximately 4 months.

  33. Part B: Insulin Dose-Adjusted Peak MMTT-Stimulated C-Peptide Concentration at Week 12

    Peak MMTT-stimulated C-peptide concentration adjusted for insulin dose using the protocol-specified calculation method

    Time frame: Part B: Approximately 4 months.

  34. Part B: Insulin Dose-Adjusted MMTT-Stimulated C-Peptide Concentration at 90 Minutes at Week 12

    MMTT-stimulated C-peptide concentration at 90 minutes, adjusted for insulin dose using the protocol-specified calculation method

    Time frame: Part B: Approximately 4 months.

  35. Part B: Intact Proinsulin-to-C-Peptide Ratio at Week 12

    Ratio of intact proinsulin concentration to C-peptide concentration, calculated using the protocol-specified method

    Time frame: Part B: Approximately 4 months.

  36. Part B: Homeostasis Model Assessment of Beta-Cell Function (HOMA-β) at Week 12

    HOMA-β is an estimate of beta-cell function calculated from fasting glucose and fasting insulin concentrations using the protocol-specified formula

    Time frame: Part B: Approximately 4 months.

  37. Part B: C-Peptide-to-Glucose Ratio at Week 12

    Ratio of C-peptide concentration to the corresponding glucose concentration, calculated using the protocol-specified sampling time point and units

    Time frame: Part B: Approximately 4 months.

  38. Part B: Proinsulin Concentration at Week 12

    Proinsulin concentration measured in the specified biological sample using the protocol-specified assay. Specify whether the measure refers to intact proinsulin, total proinsulin, or another defined analyte

    Time frame: Part B: Approximately 4 months.

  39. Part B: Proinsulin-to-C-Peptide Ratio at Week 12

    Ratio of the specified proinsulin concentration to C-peptide concentration, calculated using the protocol-specified method

    Time frame: Part B: Approximately 4 months.

  40. Part B: C-Peptide-Based Insulinogenic Index at Week 12

    An index of glucose-stimulated insulin secretion calculated from C-peptide and glucose measurements using the protocol-specified formula and sampling time points

    Time frame: Part B: Approximately 4 months.

Other outcomes

  1. Part B: To evaluate the time in glycemic target range [TIR]

    Assess the time in glycemic target range \[TIR\]

    Time frame: Part B: Approximately 4 months.

  2. Part B: Change from baseline of serum PDIA4 during the study

    Assess the protein disulfide isomerase A4 (PDIA4)

    Time frame: Part B: Approximately 4 months.

  3. Part B: To evaluate the effect of oral administration of PS1 on T1D-related immunologic and endocrinologic parameters

    Assessment of serum proinflammatory and regulatory cytokine profiles and other immune mediators (examples of cytokines that may be evaluated are interleukin \[IL\]-4, IL-10, and interferon gamma \[IFNγ\])

    Time frame: Part B: Approximately 4 months.

  4. Part B: To explore changes in body mass index (BMI)

    Assess the BMI

    Time frame: Part B: Approximately 4 months.

  5. Part B: Consistency of Treatment Effects Across Baseline C-Peptide AUC Subgroups

    To explore the consistency of treatment effects on the primary efficacy outcome across subgroups defined by baseline 4-hour MMTT-stimulated C-peptide AUC.

    Time frame: Part B: Approximately 4 months.

  6. Part B: Consistency of Treatment Effects Across Baseline HbA1c Subgroups

    To explore the consistency of treatment effects on the primary efficacy outcome across subgroups defined by baseline HbA1c.

    Time frame: Part B: Approximately 4 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Aug 2028, 20 months later.

Of 51 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 20 months is close to that.

Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 17 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2026
First posted
Oct 22, 2026
StartEst.
Nov 21, 2026
Primary completionEst.
Aug 15, 2028
CompletionEst.
Oct 31, 2028
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07889505
Lead sponsor
Pharmasaga Co. Ltd.
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Nov 21, 2026 (estimated)
Primary completion
Aug 15, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Yuyu Chung, Master
Contact
pm@pharmasaga.com
+886-2-2793-8665 ext. 302

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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