Type 2 Diabetes MellitusPhase 3NCT06731075

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

A Phase 3 study testing ORMD-0801 8 mg and ORMD-0801 16 mg in people with Type 2 Diabetes Mellitus, run by Oramed, Ltd. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: ORMD-0801 8 mg and ORMD-0801 16 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2025to 22 May 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects aged ≥ 50 years.
Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.2% but ≤ 10.0% at Screening.
On a stable dose of at least one and up to three of the following glucose-lowering agents: Metformin, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, insulin secretagogue, oral or injected GLP-1 receptor agonists, glucosidase inhibitor, or pramlintide (injected insulin is excluded) for a minimum of 3 months prior to Screening.
Body mass index (BMI) of ≤ 28 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
Renal function - eGFR ≥ 30 ml/min.
Females of childbearing potential must:

Show all 15Show fewer

- a. Have a negative serum pregnancy test result at Screening.
- b. Agree to avoid becoming pregnant while receiving IP for at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP.
- c. Agree to use an acceptable method of contraception at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP. Acceptable methods of contraception are hormonal contraception (contraceptive pill or injection) PLUS an additional barrier method of contraception such as a diaphragm, condom, sponge, or spermicide.
- d. In the absence of hormonal contraception, double-barrier methods must be used which include a combination of any two of the following: diaphragm, condom, copper intrauterine device, sponge, or spermicide, and must be used for at least 30 days prior to administration of IP, during the entire study, and for 30 days following their last dose of IP.
- e. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
- f. Females who are not of childbearing potential are defined as:
- - - - - i. Postmenopausal (defined as at least 12 months with no menses in women ≥ 45 years of age); OR
- - - - - ii. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR
- - - - - iii. Have a congenital or acquired condition that prevents childbearing.

Who cannot join

Type 1 diabetes by history.
Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
Treatment involving injected insulin within 3 months prior to Visit 1.
A history of > 2 episodes of severe hypoglycemia within 6 months prior to Screening.
A history of hypoglycemic unawareness.
A history of unstable angina or myocardial infarction within 6 months prior to Screening, New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure (CHF), valvular heart disease, ventricular cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke, or transient ischemic attack (TIA) within 6 months prior to Screening.

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A history of uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg. A single repeat measurement will be permitted
Renal dysfunction: eGFR < 30 mL/min.
A history of or active proliferative retinopathy requiring treatment.
Psychiatric disorders that, per Investigator judgment, may have impact on the safety of the subject or interfere with subject's participation or compliance in the study.
Laboratory abnormalities at Screening including:
- - a. Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal; a single repeat test is allowable.
- - b. Elevated liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)) > 3X the upper limit of normal; a single repeat test is allowable.
- - c. Very elevated fasting triglyceride levels (> 600 mg/dL); a single repeat test is allowable.
- - d. Any relevant abnormality that would interfere with the efficacy or the safety assessments during study treatment administration.
Positive history of active liver disease (other than non-alcoholic hepatic steatosis), primary biliary cirrhosis, or active symptomatic gallbladder disease.
Positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus ribonucleic acid (RNA).
Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to baseline.
Use of the following medications:
- - -a. History of use of any injectable insulin (greater than 7 days) within 6 months prior to Screening.
- - -b. Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening.
- - - c. Use of oral, intravenous, or intramuscular steroids for one month prior to enrollment. Intra-articular and/or topical corticosteroids are not considered systemic.
- - - d. Concurrent use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and immunosuppressive or immunomodulating agents. Inhaled nasal steroids are permissible.
Known allergy to soy.
Involvement in a weight loss program and is not in the maintenance phase, or subject has started weight loss medication (e.g., orlistat or liraglutide) within 3 months prior to Screening.
Prior bariatric surgery.
Subject is pregnant or breast-feeding.
Subject is a user of recreational or illicit drugs or has had a recent history (within 1 year of Screening) of drug or alcohol abuse or dependence. (Note: Alcohol abuse includes heavy alcohol intake as defined by > 3 drinks per day or > 14 drinks per week or binge drinking) at Screening. Occasional intermittent use of cannabinoid products will be allowed provided that no cannabinoid products have been used during the 1 week prior to each visit.
Weight loss preparations either approved and marketed or used in OTC preparations except for GLP-1 used in the treatment of underlying diabetes.
Any condition or other factor (at the Investigator's discretion) that is deemed unsuitable for subject enrollment into the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Miriam Kidron, Ph.D. contact

972-2-566-0001

miriam@oramed.com

Meir S. Silver, Ph.D. contact

+19706804074

meir@oramed.com

United States1 site

Velocity Clinical Research Dallas
Dallas, Texas, 75230
Kathleen Crawford, 682-348-1169, kcrawford@velocityclinical.com
Julio Rosenstock, MD, 214-402-6779, juliorosenstock@dallasdiabetes.com

Other trials in United States

About this study

Official title: 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

Read the 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:

Sex (Male, Female)
Age Group (60 years and younger, over 60 years)
Baseline A1C (Less than or equal to 9.0, Greater than 9.0)
Race
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:

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).
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.
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.
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
Being tested: ORMD-0801 8 mg, Placebo capsule, ORMD-0801 16 mg
Keywords: Oral Insulin, Type 2 Diabetes Mellitus (T2DM)
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ORMD-0801 8 mgDrug
Also called Oral Insulin
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 capsuleOther
Placebo capsule
ORMD-0801 16 mgDrug
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 groups in NCT06731075
Study group	Role	What they receive
ORMD-0801 8 mg once-daily at night - QD	Active comparator	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). Receives: Drug: ORMD-0801 8 mg; Other: Placebo capsule
ORMD-0801 8 mg twice daily - BID	Active comparator	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. Receives: Drug: ORMD-0801 8 mg; Other: Placebo capsule
ORMD-0801 16 mg once-daily at night - QD	Active comparator	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. Receives: Other: Placebo capsule; Drug: ORMD-0801 16 mg
Placebo	Placebo comparator	The subject receives 3 placebo capsules. Receives: Other: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in A1C at 26 weeks
Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6).
Measured: Visit 1 (baseline) and Visit 6 (week 26)

Secondary outcomes (3)

Incidence of A1C < 7% at 26 weeks (Visit 6).
Number of subjects that have a value of A1C less than 7%
Measured: Week 26
Change from baseline in fasting plasma glucose at week 26
Change from baseline in fasting plasma glucose (FPG) at week 26
Measured: Baseline (Visit 1) to Week 26 (Visit 6)
Safety Assessment by number of adverse events.
Safety assessed by number of adverse events including adverse events of special interest such as hypoglycemia.
Measured: Visit 1 (baseline) through Visit 6 (week 26)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202522 May 2027

First posted12 Dec 2024
Study start15 Dec 2025 (estimated)
Primary completion25 Apr 2027 (estimated)
Study completion22 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06731075
Sponsor's protocol ID: ORA-D-013-3
Status last verified: Jul 2025
First submitted: 9 Dec 2024
Last updated: 3 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Only anonymized IPD will be shared.

Publications

Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
PubMed 18945920
Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006 Aug;29(8):1963-72. doi: 10.2337/dc06-9912. No abstract available.
PubMed 16873813
Li X, Yang S, Cao C, Yan X, Zheng L, Zheng L, Da J, Tang X, Ji L, Yang X, Zhou Z. Validation of the Swedish Diabetes Re-Grouping Scheme in Adult-Onset Diabetes in China. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa524. doi: 10.1210/clinem/dgaa524.
PubMed 32808015
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S41-S48. doi: 10.2337/dc23-S003.
PubMed 36507633
Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922
Cleary PA, Orchard TJ, Genuth S, Wong ND, Detrano R, Backlund JY, Zinman B, Jacobson A, Sun W, Lachin JM, Nathan DM; DCCT/EDIC Research Group. The effect of intensive glycemic treatment on coronary artery calcification in type 1 diabetic participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes. 2006 Dec;55(12):3556-65. doi: 10.2337/db06-0653.
PubMed 17130504
Mansour Aly D, Dwivedi OP, Prasad RB, Karajamaki A, Hjort R, Thangam M, Akerlund M, Mahajan A, Udler MS, Florez JC, McCarthy MI; Regeneron Genetics Center; Brosnan J, Melander O, Carlsson S, Hansson O, Tuomi T, Groop L, Ahlqvist E. Genome-wide association analyses highlight etiological differences underlying newly defined subtypes of diabetes. Nat Genet. 2021 Nov;53(11):1534-1542. doi: 10.1038/s41588-021-00948-2. Epub 2021 Nov 4.
PubMed 34737425

Interested in taking part?

Miriam Kidron, Ph.D.

972-2-566-0001

miriam@oramed.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06731075
Acronym / sponsor ID: ORA-D-013-3
Conditions: Type 2 Diabetes Mellitus
Keywords: Oral Insulin, Type 2 Diabetes Mellitus (T2DM)
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: Oramed, Ltd.Industry (pharma, biotech, devices)
Collaborators: InClin, Inc.
Study start: 15 Dec 2025 (estimated)
Primary completion: 25 Apr 2027 (estimated)
Study completion: 22 May 2027 (estimated)
First posted: 12 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Sex (Male, Female)
Age Group (60 years and younger, over 60 years)
Baseline A1C (Less than or equal to 9.0, Greater than 9.0)
Race
Ethnicity

Screening Period

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:

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).
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.
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.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model 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.

Arm	Type	Receives
ORMD-0801 8 mg once-daily at night - QD	Active comparator	Drug: ORMD-0801 8 mg, Other: Placebo capsuleDouble-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).
ORMD-0801 8 mg twice daily - BID	Active comparator	Drug: ORMD-0801 8 mg, Other: Placebo capsuleDouble-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.
ORMD-0801 16 mg once-daily at night - QD	Active comparator	Other: Placebo capsule, Drug: ORMD-0801 16 mgDouble-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	Placebo comparator	Other: Placebo capsuleThe subject receives 3 placebo capsules.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Male and female subjects aged ≥ 50 years.
Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.2% but ≤ 10.0% at Screening.
On a stable dose of at least one and up to three of the following glucose-lowering agents: Metformin, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, insulin secretagogue, oral or injected GLP-1 receptor agonists, glucosidase inhibitor, or pramlintide (injected insulin is excluded) for a minimum of 3 months prior to Screening.
Body mass index (BMI) of ≤ 28 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
Renal function - eGFR ≥ 30 ml/min.

Key exclusion criteria (30 listed)

Type 1 diabetes by history.
Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
Treatment involving injected insulin within 3 months prior to Visit 1.
A history of > 2 episodes of severe hypoglycemia within 6 months prior to Screening.
A history of hypoglycemic unawareness.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ORMD-0801 8 mgAlso: Oral Insulin1 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).	Drug	ORMD-0801 8 mg once-daily at night - QD, ORMD-0801 8 mg twice daily - BID
Placebo capsulePlacebo capsule	Other	ORMD-0801 16 mg once-daily at night - QD, ORMD-0801 8 mg once-daily at night - QD, ORMD-0801 8 mg twice daily - BID, Placebo
ORMD-0801 16 mg2 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.	Drug	ORMD-0801 16 mg once-daily at night - QD

Primary outcome

Change from baseline in A1C at 26 weeks
Time frame: Visit 1 (baseline) and Visit 6 (week 26)
Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6).

3 secondary outcomes

Incidence of A1C < 7% at 26 weeks (Visit 6).
Time frame: Week 26
Change from baseline in fasting plasma glucose at week 26
Time frame: Baseline (Visit 1) to Week 26 (Visit 6)
Safety Assessment by number of adverse events.
Time frame: Visit 1 (baseline) through Visit 6 (week 26)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
Background: PubMed 18945920Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
Background: PubMed 16873813Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006 Aug;29(8):1963-72. doi: 10.2337/dc06-9912. No abstract available.
Background: PubMed 32808015Li X, Yang S, Cao C, Yan X, Zheng L, Zheng L, Da J, Tang X, Ji L, Yang X, Zhou Z. Validation of the Swedish Diabetes Re-Grouping Scheme in Adult-Onset Diabetes in China. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa524. doi: 10.1210/clinem/dgaa524.
Background: PubMed 36507633ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 3. Prevention or Delay of Type 2 Diabetes and Associated Comorbidities: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S41-S48. doi: 10.2337/dc23-S003.
Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
Background: PubMed 17130504Cleary PA, Orchard TJ, Genuth S, Wong ND, Detrano R, Backlund JY, Zinman B, Jacobson A, Sun W, Lachin JM, Nathan DM; DCCT/EDIC Research Group. The effect of intensive glycemic treatment on coronary artery calcification in type 1 diabetic participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes. 2006 Dec;55(12):3556-65. doi: 10.2337/db06-0653.
Background: PubMed 34737425Mansour Aly D, Dwivedi OP, Prasad RB, Karajamaki A, Hjort R, Thangam M, Akerlund M, Mahajan A, Udler MS, Florez JC, McCarthy MI; Regeneron Genetics Center; Brosnan J, Melander O, Carlsson S, Hansson O, Tuomi T, Groop L, Ahlqvist E. Genome-wide association analyses highlight etiological differences underlying newly defined subtypes of diabetes. Nat Genet. 2021 Nov;53(11):1534-1542. doi: 10.1038/s41588-021-00948-2. Epub 2021 Nov 4.
Individual participant dataSharing planned: Yes. Only anonymized IPD will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Miriam Kidron, Ph.D. contact

972-2-566-0001

miriam@oramed.com

Meir S. Silver, Ph.D. contact

+19706804074

meir@oramed.com

Miriam Kidron, Ph.D. study director

Oramed, Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ORMD-0801 8 mg and ORMD-0801 16 mg in people with Type 2 Diabetes Mellitus, run by Oramed, Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Miriam Kidron, Ph.D. (972-2-566-0001, miriam@oramed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in A1C at 26 weeks (time frame: Visit 1 (baseline) and Visit 6 (week 26)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731075, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.