NCT06731075

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

A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on One to Three Glucose-lowering Agents

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Oramed, Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this study and will be required to complete this thirty-four-week clinical trial.

Detailed description

In this randomized, double-blind, double dummy, placebo-controlled study, approximately 300 eligible subjects with T2DM and inadequate control on at least one to three glucose-lowering agents will undergo an initial 4-week Screening Period. This will be followed by a 26-week Double-Blind Treatment Period, commencing with a safety Follow-up Visit four weeks after the completion of the trial. Analysis for the primary and secondary endpoints will be provided for the following subgroups of baseline factors: 1. Sex (Male, Female) 2. Age Group (60 years and younger, over 60 years) 3. Baseline A1C (Less than or equal to 9.0, Greater than 9.0) 4. Race 5. Ethnicity Screening Period The Investigator will review the aim of the study, study procedures and potential risks and benefits. These subjects will then sign a written informed consent during the Screening Visit 1 (Screen 1) following which various study procedures will be performed (refer to Table 2). They will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2 (Screen 2). At this visit, a CGM sensor will be placed with appropriate instructions by the study team for a 10-day blinded continuous glucose monitoring (CGM) data collection by the site. Subjects will then return to the clinic after 10 days (± 1-day) for removal of the CGM sensor. The subjects will be randomized to one of the four arms of the study treatment. Treatment Period After the Screening Period, subjects will be randomized to 26 weeks of Double-Blind Treatment. In a double-blind, double dummy randomization scheme, subjects will be randomized to one of the following four treatment arms: 1. ORMD-0801 8 mg once-daily at night - QD: 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night). 2. ORMD-0801 8 mg twice daily - BID: 1 x 8 mg capsule each morning approximately 45 minutes (±15 minutes) prior to breakfast and 1 x 8 mg capsule each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) and 1 placebo capsule at night. 3. ORMD-0801 16 mg once-daily at night - QD: 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning. 4. Placebo. During the Double-Blind Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic at Week 24 - Visit 5 (10 days prior to Week 26 for CGM application) and Week 26 - Visit 6 (CGM removal and end of Double-Blind Treatment Period visit). The visit requiring CGM application will occur 10 days prior to the CGM removal visit within ± 1-day window. Safety Follow-up/End of Study All subjects completing the trial will return to the clinic in 4 weeks ± 3 days for a safety Follow-up Visit. Study procedures and assessments will be performed. Subjects withdrawing prematurely from the trial will have the early termination (ET) visit procedures completed. All patients will continue to be followed in accordance with ITT principles to avoid lost to follow-up and missing data. Throughout the course of the study, subjects will measure and record fasting blood glucose levels at least 2-3 times a week \[self-monitored blood glucose (SMBG)\] or when they experience any symptoms of hypoglycemia using a glucose meter. Subjects will be provided a paper diary at each clinic visit and trained to record information related to fasting blood glucose and description of hypoglycemic events: time and date of occurrence; symptoms experienced, if any; treatment given, if any; and specific circumstances. Subjects will be required to bring the paper diary at each clinic visit where data will be reviewed.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ORMD-0801 8 mg	1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).
OTHER	Placebo capsule	Placebo capsule
DRUG	ORMD-0801 16 mg	2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning.

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-04-25
• Completion: 2027-05-22
• First posted: 2024-12-12
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study