A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT04754334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.
Study identification
- NCT ID
- NCT04754334
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Oramed, Ltd.
- Industry
- Enrollment
- 346 participants
Conditions and interventions
Conditions
Interventions
- ORMD-0801 Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2021
- Primary completion
- Jan 12, 2023
- Completion
- Jan 12, 2023
- Last update posted
- Feb 8, 2023
2021 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Institute of South Florida, Inc. (PHARMASEEK) | Coral Gables | Florida | 33124 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04754334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2023 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04754334 live on ClinicalTrials.gov.