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NCT04754334 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

A Phase 3 study, sponsored by Oramed.

Terminated
Registry status
Phase 3
Development phase
346
Enrollment target

NCT04754334 is a Phase 3 study that was terminated before completion, run by Oramed. The registered enrollment target is 346 participants.

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The verdict

NCT04754334, a Phase 3 study, was terminated before completion, sponsored by Oramed.

TERMINATED
Registry status
Phase 3
Development phase
346 participants
Enrollment target

Study Summary

This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.

Interventions

  • OTHER Placebo
  • DRUG ORMD-0801

Trial Details

FieldValue
Enrollment Target 346 participants
Start Date 2021-03-16
Est. Completion 2023-01-13
Phase Phase 3

Sponsor

Oramed

11 total trials

What the Registry Record Tells You About NCT04754334

The ClinicalTrials.gov registry entry for NCT04754334 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 346 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oramed, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04754334 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04754334 about?

NCT04754334 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus". This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and ...

What is the current status of trial NCT04754334?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2021-03-16. Estimated completion is 2023-01-13.

What interventions are being tested in trial NCT04754334?

The interventions under investigation include: Placebo (OTHER), ORMD-0801 (DRUG).

Who is sponsoring clinical trial NCT04754334?

This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.