NCT06731075View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 15, 2025

Primary Completion Date

April 25, 2027

Study Completion Date

May 22, 2027

Conditions
Type 2 Diabetes Mellitus
Interventions
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.

Trial Locations (1)

75230

Velocity Clinical Research Dallas, Dallas

All Listed Sponsors
collaborator

InClin, Inc.

UNKNOWN

lead

Oramed, Ltd.

INDUSTRY