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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Oramed, Ltd.
Study ID
NCT06731075
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ORMD-0801 8 mg — DRUG
    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).
  • Placebo capsule — OTHER
    Placebo capsule
  • ORMD-0801 16 mg — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Jul 2025
Primary completion
Apr 25, 2027
Completion
May 22, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ORMD-0801 8 mg once-daily at night - QD
    Double-Dummy; the subject receives both experimental drug and placebo. 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).
  • Active Comparator: ORMD-0801 8 mg twice daily - BID
    Double-Dummy; the subject receives both experimental drug and placebo. 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.
  • Active Comparator: ORMD-0801 16 mg once-daily at night - QD
    Double-Dummy; the subject receives both experimental drug and placebo. 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.
  • Placebo Comparator: Placebo
    The subject receives 3 placebo capsules.

Primary Outcome Measure

Change from baseline in A1C at 26 weeks [ Time Frame: Visit 1 (baseline) and Visit 6 (week 26) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research DallasDallasTexas75230
Kathleen Crawford
[email protected]
682-348-1169
Julio Rosenstock, MD
[email protected]
214-402-6779
Julio Rosenstock, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Velocity Clinical Research Dallas· Dallas, TX

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