deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT04616014

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

An Open-Label Multi-Center Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

Sponsor: Oramed, Ltd.

Conditions Nonalcoholic Steatohepatitis (NASH)
Interventions ORMD-0801 QD
Updated 14 times since 2020 Last updated: Mar 27, 2024 Started: Mar 1, 2021 Primary completion: Jul 1, 2022 Completion: Sep 15, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Nonalcoholic Steatohepatitis (NASH), this trial is completed. The trial is conducted by Oramed, Ltd. and has accumulated 14 data snapshots since 2021. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Dec 2021 · 6 months · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Apr 2024 · 19 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

14 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE2

  5. Sep 2022 — Apr 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 9 earlier versions

  1. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Apr 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  3. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  4. Dec 2021 — Feb 2022 [monthly]

    Recruiting PHASE2

  5. Jun 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  6. Apr 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE2

  7. Feb 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE2

  8. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting PHASE2

  9. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Oramed, Ltd.
Data source: Oramed, Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations