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Clinical Trial Details

Trial ID: L5373
Source ID: NCT06731075
Associated Drug: Ormd-0801 8 Mg
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus.
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ORMD-0801 8 mg|OTHER: Placebo capsule|DRUG: ORMD-0801 16 mg
Outcome Measures: Primary: Change from baseline in A1C at 26 weeks, Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6)., Visit 1 (baseline) and Visit 6 (week 26) | Secondary: Incidence of A1C < 7% at 26 weeks (Visit 6)., Number of subjects that have a value of A1C less than 7%, Week 26|Change from baseline in fasting plasma glucose at week 26, Change from baseline in fasting plasma glucose (FPG) at week 26, Baseline (Visit 1) to Week 26 (Visit 6)|Safety Assessment by number of adverse events., Safety assessed by number of adverse events including adverse events of special interest such as hypoglycemia., Visit 1 (baseline) through Visit 6 (week 26) | Other: Changes from baseline over time for A1C, Changes from baseline over time for A1C and during the Double-Blind Treatment Period., Measurements between Visit 1 (baseline) and Visit 6 (week 26)|Changes from baseline over time for FPG, Changes from baseline over time for FPG during the Double-Blind Treatment Period., Measurements between Visit 1 (baseline) and Visit 6 (week 26)|Change of Mean Sensor Glucose,, Change in CGM Mean Sensor Glucose from baseline to week 26., Baseline (Visit 1) to Week 26 (Visit 6)|Time in Range (TIR) of Sensor Glucose < 54 mg/dL, Time in Range duration of CGM Sensor Glucose when Sensor Glucose falls in the range of \< 54 mg/dL, Baseline (Visit 1) to Week 26 (Visit 6)|Time in Range (TIR) of Sensor Glucose 54-69 mg/dL, Time in Range duration of CGM Sensor Glucose when Sensor Glucose falls in the range of 54-69 mg/dL, Baseline (Visit 1) to Week 26 (Visit 6)|Time in Range (TIR) of Sensor Glucose 70-180 mg/dL, Time in Range duration of CGM Sensor Glucose when Sensor Glucose falls in the range of 70-180 mg/dL, Baseline (Visit 1) to Week 26 (Visit 6)|Time in Range (TIR) of Sensor Glucose 180-250 mg/dL, Time in Range duration of CGM Sensor Glucose when Sensor Glucose falls in the range of 180-250 mg/dL, Baseline (Visit 1) to Week 26 (Visit 6)|Time in Range (TIR) of Sensor Glucose >250 mg/dL, Time in Range duration of CGM Sensor Glucose when Sensor Glucose falls in the range of \>250 mg/dL, Baseline (Visit 1) to Week 26 (Visit 6)|Incidence of A1C < 8% at 26 weeks, Incidence of A1C \< 8% at 26 weeks (Visit 6)., 26 Weeks (Visit 6)|Incidence rate of subjects requiring glycemic rescue therapy and the time to rescue., Incidence rate of subjects requiring glycemic rescue therapy and the time to rescue during the Double-Blind Treatment Period., Baseline (Visit1) through Week 26 (Visit 6)|Change in weight from baseline, Change in weight from baseline during the Double-Blind Treatment Period., Baseline (Visit 1) and Week 26 (Visit 6)|Changes from baseline over time for C-peptide, Changes from baseline over time for C-peptide during the Double-Blind Treatment Period., Baseline (Visit 1) through Week 26 (Visit 6)|Changes from baseline over time in fasting insulin, Changes from baseline over time in fasting insulin during the Double-Blind Treatment Period., Baseline (Visit 1) through Week 26 (Visit 6)
Sponsor/Collaborators: Sponsor: Oramed, Ltd. | Collaborators: InClin, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-03-15
Completion Date: 2026-05-22
Results First Posted:
Last Update Posted: 2025-02-07
Locations: Velocity Clinical Research Dallas, Dallas, Texas, 75230, United States
URL: https://clinicaltrials.gov/show/NCT06731075