Type I DiabetesPhase 2NCT06964087
Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
A Phase 2 study testing OPT101 in people with Type I Diabetes, run by Op-T LLC at 5 sites in United States.
Trial summary
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- OPT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Apr 2026to 19 Aug 2028
- Phase
- Phase 2
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).
- 2. Willing to wear a continuous glucose monitor for the duration of the trial (e.g., Freestyle Libre 3).
- 3. Male or female aged ≥18 to 50 years on the day of signing informed consent. 4. Diagnosis of T1DM within the last 20 years for Part A, within 1 to 10 years [N=15 at >5 to 10, N=12 at 1 to 5 yrs] for Part B, within less than or equal to 1 year for Part C.
- 5. For Parts B and C only, T-cell phenotype Th40 level greater than or equal to 35% of CD3+ leukocytes (performed at the OPT lab).
- 6. Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening.
- 7. Women of childbearing potential (WOCBP) must have a negative highly sensitive serum test (beta- human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving the investigational product.
- 8. WOCBP must agree to use one of the following methods of birth control for the duration of the clinical trial: Systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.
Who cannot join
- 1. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ.
- 2. Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia.
- 3. Has chronic kidney disease of Stage 2 or higher with eGFR of <90 mL/min/1.73m2.
- 4. Is currently receiving an immuno-modulatory treatment. 5. Patients with a history of venous and arterial thromboembolic events including, but not limited to, the following:
- Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.
- Patients with recent immobilization or recent surgery.
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- Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome.
- 6. Has an active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus, cytomegalovirus, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii pneumonia, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer.
- 7. Has recent or active hepatitis A infection, current/chronic hepatitis B and hepatitis C infection, or HIV infection. Participants with immunity to hepatitis B from previous infection, defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody [anti-HBs] or vaccination [defined as negative HBsAg, negative anti-HBc, and positive anti-HBs] are eligible to participate.
- 8. Has a history of latent or active tuberculosis. 9. Has received a live attenuated vaccine within the last 60 days including patients who plan to receive live attenuated vaccines during the study or within 60 days after the final dose of study treatment.
- 10. Patients with the following should be excluded:
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- Abnormal coagulation test at screening: prothrombin time (PT; >14 sec), activated partial thromboplastin time (aPTT; >32 sec) or fibrinogen level (<190 or >450 mg/dL).
- Abnormal liver function tests (except in the case of known Gilbert's syndrome):
- AST or ALT ≥3x ULN and total bilirubin ≥2x ULN ii. AST or ALT ≥5x ULN iii. Abnormal platelet counts (<150 or > 450 x10 to the third/uL) iv. Abnormal white blood cell counts (< 3.0 or >11.0 x10 to the third/uL ) v. Abnormal eGFR (< 90 mL/min) vi. Abnormal Factor VIII (<50% or >150% of normal) vii. Abnormal D-Dimer (> 500 ng/mL of fibrinogen equivalent units (FEU)) 11. Patients planning to undergo elective procedures or surgeries at any time after signing the ICF through the follow-up visit.
- 12. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- 13. Recent history of bleeding or bleeding disorders or any condition whereby in the opinion of the treating investigator giving anti-coagulation during treatment would be contraindicated.
- 14. History of hypersensitivity to antihistamines. 15. Body mass index <20 or >35 kg/M2 16. Patients with active drug or alcohol abuse within one year prior to screening or patients who test positive for required drug testing during screening (refer to §8.4).
- 17. Patient is participating in a clinical trial of another investigational drug or device, including patients who have participated in another study for duration of 5 half-lives of the investigational agent.
- 18. Patient is a prisoner. 19. Patients with any medical condition, including, but not limited to, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or a psychiatric condition that, in the opinion of the Investigator, could compromise their ability to participate in this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Barbara Davis Center - University of Colorado Anschuttz Medical Campus
Aurora, Colorado, 80045
Lisa Boswell, (303) 503-9954, lb@op-t.com
- Recruiting
University of Alabama at Birmingham - Department of Medicina
Birmingham, Alabama, 35294
Lisa Boswell, (303) 503-9954, lb@op-t.com
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Lisa Boswell, (303) 503-9954, lb@op-t.com
- Recruiting
Rainier Clinical Research Center
Renton, Washington, 98057
Lisa Boswell, (303) 503-9954, lb@op-t.com
- Recruiting
Diablo Clinical Research Center
Walnut Creek, California, 94598
Lisa Boswell, (303) 503-9954, lb@op-t.com
About this study
Official title: A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients With Recent Onset Type 1 Diabetes Mellitus
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.
Read the detailed description
This multipart study begins with an open label exploration of tolerance and pharmacokinetics of subcutaneously (SC) administered OPT101, given at increasing doses of 1.0, 1.5, or 2.0 mg/kg three times per week for two weeks to separate sequential cohorts of six adult patients (n=18 total) diagnosed with type 1 diabetes mellitus within 20 years of screening. In this Part A, serum C-peptide levels will not be a consideration.
In Part B, the highest tolerated dose will then be tested over one year in a total of n=27 subjects having C-peptide 0.2 ng/ml, with 12 diagnosed within 1 to 5 years of screening, and 15 diagnosed within >5 to 10 years. Randomization to treatment or control will be in a 2:1 ratio.
An optional Part C will enroll an additional n=27 subjects having C-peptide 0.2 ng/ml who are 1 year from diagnosis with type 1 diabetes. Subjects will be randomized to treatment or control in a 2:1 ratio and will be treated for one year.
- Conditions
- Type I Diabetes
- Being tested
- OPT101, OPT101 Placebo to Match (PTM)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT101Drug
Subcutaneous injection.
OPT101 Placebo to Match (PTM)Other
5% Dextrose (w/v)
| Study group | Role | What they receive |
|---|---|---|
| OPT101, 1.0mg/kg, 1.5 mg/kg and 2.0 mg/kg | Experimental | Part A. 6 subjects will receive 1.0mg/kg OPT101 6 subjects will receive 1.5mg/kg OPT101 6 subjects will receive 2.0mg/kg OPT101 Receives: Drug: OPT101 |
| Part B - OPT101 and Placebo to Match | Experimental | The highest tolerated dose from Part A will be tested over 48 weeks. 27 subjects (18 investigational product: 9 placebo) Receives: Drug: OPT101; Other: OPT101 Placebo to Match (PTM) |
| Part C - OPT101 and Placebo to Match | Experimental | The highest tolerated dose in Part A will be dosed. 27 subjects (18 investigational product, 9 placebo) Receives: Drug: OPT101; Other: OPT101 Placebo to Match (PTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C-peptide (ng/mL)
Change from baseline to End of Study in mixed-meal stimulated C-peptide (ng/mL). The area under the time-C-Peptide curve (AUC) is calculated, and the weighted mean C-peptide is used to convert the measurement back to nanomoles per liter.
Measured: 48-week
Secondary outcomes (5)
PK Parameter - Maximum Concentration (Cmax)
Maximum Concentration (Cmax)
Measured: 48-week
PK Parameter - Time to reach maximum concentration (Tmax)
Time to reach maximum concentration (Tmax)
Measured: 48-week
PK Parameter - terminal half-life t1/2
Terminal half-life t1/2
Measured: 48-week
PK Parameter - Area under the curve
Area under the curve (AUC)
Measured: 48-week
Propotion of subjects with change in C-peptide greater than or equal to 0.2 ng/mL
Proportion of subjects with mixed-meal stimulated C-peptide peak levels greater than or equal to 0.2 ng/mL at End of Study.
Measured: 48-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start10 Apr 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion19 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Op-T LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964087
- Sponsor's protocol ID
- OPT101-200-10
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients With Recent Onset Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06964087
- Acronym / sponsor ID
- OPT101-200-10
- Conditions
- Type I Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Op-T LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 19 Aug 2028 (estimated)
- First posted
- 9 May 2025 (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.
This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.
Detailed description
This multipart study begins with an open label exploration of tolerance and pharmacokinetics of subcutaneously (SC) administered OPT101, given at increasing doses of 1.0, 1.5, or 2.0 mg/kg three times per week for two weeks to separate sequential cohorts of six adult patients (n=18 total) diagnosed with type 1 diabetes mellitus within 20 years of screening. In this Part A, serum C-peptide levels will not be a consideration.
In Part B, the highest tolerated dose will then be tested over one year in a total of n=27 subjects having C-peptide 0.2 ng/ml, with 12 diagnosed within 1 to 5 years of screening, and 15 diagnosed within >5 to 10 years. Randomization to treatment or control will be in a 2:1 ratio.
An optional Part C will enroll an additional n=27 subjects having C-peptide 0.2 ng/ml who are 1 year from diagnosis with type 1 diabetes. Subjects will be randomized to treatment or control in a 2:1 ratio and will be treated for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPT101, 1.0mg/kg, 1.5 mg/kg and 2.0 mg/kg | Experimental | Drug: OPT101Part A. 6 subjects will receive 1.0mg/kg OPT101 6 subjects will receive 1.5mg/kg OPT101 6 subjects will receive 2.0mg/kg OPT101 |
| Part B - OPT101 and Placebo to Match | Experimental | Drug: OPT101, Other: OPT101 Placebo to Match (PTM)The highest tolerated dose from Part A will be tested over 48 weeks. 27 subjects (18 investigational product: 9 placebo) |
| Part C - OPT101 and Placebo to Match | Experimental | Drug: OPT101, Other: OPT101 Placebo to Match (PTM)The highest tolerated dose in Part A will be dosed. 27 subjects (18 investigational product, 9 placebo) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).
- 2. Willing to wear a continuous glucose monitor for the duration of the trial (e.g., Freestyle Libre 3).
- 3. Male or female aged ≥18 to 50 years on the day of signing informed consent. 4. Diagnosis of T1DM within the last 20 years for Part A, within 1 to 10 years [N=15 at >5 to 10, N=12 at 1 to 5 yrs] for Part B, within less than or equal to 1 year for Part C.
- 5. For Parts B and C only, T-cell phenotype Th40 level greater than or equal to 35% of CD3+ leukocytes (performed at the OPT lab).
- 6. Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening.
Key exclusion criteria (20 listed)
- 1. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ.
- 2. Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia.
- 3. Has chronic kidney disease of Stage 2 or higher with eGFR of <90 mL/min/1.73m2.
- 4. Is currently receiving an immuno-modulatory treatment. 5. Patients with a history of venous and arterial thromboembolic events including, but not limited to, the following:
- 6. Has an active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, Epstein-Barr virus, cytomegalovirus, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii pneumonia, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer.
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 |
|---|---|---|
| OPT101Subcutaneous injection. | Drug | OPT101, 1.0mg/kg, 1.5 mg/kg and 2.0 mg/kg, Part B - OPT101 and Placebo to Match, Part C - OPT101 and Placebo to Match |
| OPT101 Placebo to Match (PTM)5% Dextrose (w/v) | Other | Part B - OPT101 and Placebo to Match, Part C - OPT101 and Placebo to Match |
Primary outcome
Change in C-peptide (ng/mL)
Time frame: 48-week
Change from baseline to End of Study in mixed-meal stimulated C-peptide (ng/mL). The area under the time-C-Peptide curve (AUC) is calculated, and the weighted mean C-peptide is used to convert the measurement back to nanomoles per liter.
5 secondary outcomes
PK Parameter - Maximum Concentration (Cmax)
Time frame: 48-week
PK Parameter - Time to reach maximum concentration (Tmax)
Time frame: 48-week
PK Parameter - terminal half-life t1/2
Time frame: 48-week
PK Parameter - Area under the curve
Time frame: 48-week
Propotion of subjects with change in C-peptide greater than or equal to 0.2 ng/mL
Time frame: 48-week
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 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPT101 in people with Type I Diabetes, run by Op-T LLC at 5 sites 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 7 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lisa Boswell (303-503-9954, lb@op-t.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-peptide (ng/mL) (time frame: 48-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.