NCT04754334 is a Phase 3 clinical trial of ORMD-0801 in T2DM (Type 2 Diabetes Mellitus), sponsored by Oramed, Ltd..

Who is sponsoring NCT04754334?

NCT04754334 is sponsored by Oramed, Ltd..

What drugs are being tested in NCT04754334?

Interventions in NCT04754334: ORMD-0801, Placebo.

What condition does NCT04754334 study?

NCT04754334 studies T2DM (Type 2 Diabetes Mellitus).

Is NCT04754334 still recruiting?

NCT04754334 is currently terminated. Last updated 9 February 2023.

Last reviewed 2023-02-09 · How we verify

NCT04754334

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 3 Last updated 9 February 2023

What this trial tests

Phase 3 trial testing ORMD-0801 in T2DM (Type 2 Diabetes Mellitus) in 346 participants. Terminated before completion.

Timeline

16 March 2021

Primary endpoint
13 January 2023

13 January 2023

Quick facts

Lead sponsor	Oramed, Ltd.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	346
Start date	16 March 2021
Primary completion	13 January 2023
Estimated completion	13 January 2023
Sites	1 location across United States

Drugs / interventions tested

ORMD-0801 — full drug profile →
Placebo

Conditions studied

T2DM (Type 2 Diabetes Mellitus) — all drugs for T2DM (Type 2 Diabetes Mellitus) →

Sponsor

Oramed, Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with T2DM (Type 2 Diabetes Mellitus). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Challenges and Opportunities in the Oral Delivery of Recombinant Biologics.
Masloh S, Culot M, Gosselet F, Chevrel A, et al · · 2023 · cited 11× · PMID 37242657 · DOI 10.3390/pharmaceutics15051415
Advances in Oral Biomacromolecule Therapies for Metabolic Diseases.
Jiao Q, Huang Y, He J, Xu Y. · · 2025 · cited 3× · PMID 40006605 · DOI 10.3390/pharmaceutics17020238
Small Intestine-Targeted Long-Acting Oral Insulin Formulation Based on Engineered Milk Protein Nanoparticles.
Thamizhchelvan AM, Li Y, Padelford J, Yang C, et al · · 2026 · PMID 41442621 · DOI 10.1021/acsabm.5c02114

Verify or expand the search:

Other trials of ORMD-0801

Trials testing the same drug.

NCT04564846 — A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus · Phase 2 · completed
NCT02496000 — Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus · Phase 2 · completed

Other recruiting trials for T2DM (Type 2 Diabetes Mellitus)

Currently open trials in the same condition.

NCT07314684 — GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM · Phase 4 · recruiting
NCT07005362 — Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D · recruiting
NCT07244003 — Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control · Phase 4 · recruiting
NCT07172997 — Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers · active not recruiting
NCT06094491 — Virtual Diabetes Group Visits Across Health Systems · Phase 2 · active not recruiting

Other Oramed, Ltd. trials

Trials by the same sponsor.

NCT06731075 — A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. · Phase 3 · not yet recruiting
NCT04616014 — A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) · Phase 2 · completed
NCT04606576 — Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus · Phase 3 · terminated
NCT04618744 — A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) · Phase 2 · completed
NCT04564846 — A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04754334 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oramed, Ltd.
Last refreshed: 9 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04754334.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing