Type 1 Diabetes MellitusPhase 2T1D OBTAINNCT06812988
Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule
A Phase 2 study testing Brivekimig in people with Type 1 Diabetes Mellitus, run by Sanofi at 24 sites in 8 countries.
Trial summary
This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) on insulin… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Brivekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 28 Feb 2025to 29 Apr 2027
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant must be 18 to 35 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part A. Participant must be 12 to 21 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part B.
- Participants who meet the criteria of T1D according to American Diabetes Association (ADA 2024).
- Initiated exogenous insulin replacement therapy not longer than 90 days prior to Screening visit at which random C-peptide will be assessed.
- Receiving insulin hormone replacement therapy:
- Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study Screening:
- Glutamic acid decarboxylase (GAD-65)
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- Insulinoma Antigen-2 (IA-2)
- Zinc-transporter 8 (ZnT8) or
- Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)
- Have random C-peptide levels ≥0.2 nmol/L determined at Screening.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or intravenous (IV) antibiotics or significant chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus [CMV], Epstein-Barr Virus [EBV] as determined at Screening), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during Screening.
- History of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution.
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing.
- Evidence of any clinically significant, severe or unstable, acute or, chronically progressive, uncontrolled infection, medical or surgical condition (eg, but not limited to, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, or any known immune deficiency), or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation).
- History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
Show all 20Show fewer
- History of moderate to severe congestive heart failure (New York Health Association [NYHA] Class III or IV), or recent cerebrovascular accident, or any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol.
- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- Has other autoimmune or inflammatory conditions
- Diabetes of forms other than autoimmune T1D that include but are not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), secondary to medications or surgery, type 2 diabetes by judgment of the investigator.
- History of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured or any family history in two or more relatives (immediate family) of same cancer (ie, rare cancers, those manifesting at a young age in a parent or sibling, certain genetic-based inheritable cancers).
- Systemic corticosteroids (duration >7 days), adrenocorticotropic hormone 1 month prior to Screening.
- Any IV, intramuscular (IM) or SC administered biologic treatments (mono- or polyclonal antibodies affecting function of immune system), <3 months or <5 half-lives (whichever is longer), prior to randomization.
- Any live (attenuated or viral-vector) vaccine (including but not limited to varicella zoster, oral polio, nasal influenza, rabies) within 3 months prior to randomization or is scheduled in expected period of study (78 weeks after randomization) if this vaccination cannot be safely postponed.
- Any non-live (inactivated, mRNA, recombinant, conjugate, toxoid) vaccine administered less than 14 days prior to randomization.
- Any immunosuppressive therapy within 12 weeks prior to randomization and through 78 weeks after randomization
- Course of Thymoglobulin®, teplizumab or other immunomodulatory treatments at any time
- Any drugs that may be used for treatment of T1D and type 2 diabetes other than insulin including but not limited to metformin, glucagon-like peptide 1 (GLP-1) agonists, sodium-glucose co-transporter-2 and 1 (SGLT2/1) inhibitor, and verapamil within 2 weeks prior to Screening.
- Abnormal laboratory test(s) at Screening
- Participants who have impaired renal function with estimated glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease [MDRD] formula) <60 mL/min/1.73 m2, or using the bedside Schwartz equation in the participants under the age of 18 y.o.
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
United States5 sites
Atlanta Diabetes Associates- Site Number : 8400006
Atlanta, Georgia, 30318
IACT Health - Columbus - Talbotton Road- Site Number : 8400012
Columbus, Georgia, 31904
Profound Research - MHP - TriAtria- Site Number : 8400015
Farmington Hills, Michigan, 48334
Tekton Research - McKinney- Site Number : 8400017
McKinney, Texas, 75069
Advanced Research Institute - Odgen- Site Number : 8400007
Ogden, Utah, 84405
Argentina5 sites
Investigational Site Number : 0320001
Buenos Aires, 1119
Investigational Site Number : 0320002
Buenos Aires, 1178
Investigational Site Number : 0320005
Buenos Aires, 1180
Investigational Site Number : 0320004
Buenos Aires, 1419
Investigational Site Number : 0320003
Salta, 4400
Australia3 sites
Investigational Site Number : 0360002
Brisbane, Queensland, 4029
Investigational Site Number : 0360001
Parkville, Victoria, 3050
Investigational Site Number : 0360003
Saint Leonards, New South Wales, 2065
Chile3 sites
Investigational Site Number : 1520004
Concepción, Biobio, 4070566
Investigational Site Number : 1520003
Providencia, Reg Metropolitana de Santiago, 7500000
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7500505
Israel3 sites
Investigational Site Number : 3760001
Jerusalem, 9112001
Investigational Site Number : 3760003
Kefar Sava, 4428164
Investigational Site Number : 3760002
Ramat Gan, 5262100
Brazil2 sites
Centro de Diabetes Curitiba- Site Number : 0760005
Curitiba, Paraná, 80810-040
Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760002
São Paulo, 01228-200
Canada2 sites
Investigational Site Number : 1240006
Surrey, British Columbia, V3T 2V6
Investigational Site Number : 1240001
Vancouver, British Columbia, V5Y 3W2
About this study
Official title: A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2a Study Assessing Safety and Efficacy of Brivekimig, a Dual Anti-TNF-α and Anti-OX40L NANOBODY® Molecule, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Recently Diagnosed Type 1 Diabetes
This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study.
The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) on insulin therapy.
Read more
The study design comprises 2 parts: in Part A adult participants (18 to 35 years of age at screening) and in Part B adolescent and young adult participants (age range 12 to 21 years) will be randomized into brivekimig and placebo groups. Approximately 84 participants will be included with randomization ratio 3:1 (active:placebo).
The study includes a screening period (3 to 5 weeks), a double-blind treatment period of 52 weeks and a safety follow-up of 26 weeks.
Read the detailed description
The total study duration will be up to 83 weeks including Screening and Safety follow-up period.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Brivekimig, Placebo
- 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.
BrivekimigDrug
Pharmaceutical form: Solution Route of administration: Subcutaneous injection
PlaceboDrug
Pharmaceutical form: Solution Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Brivekimig | Experimental | Participants will receive subcutaneous injection of brivekimig. Receives: Drug: Brivekimig |
| Placebo | Placebo comparator | Participants will receive subcutaneous injection of matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration
Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)
Measured: From Baseline to Week 26
Secondary outcomes (15)
Change from baseline to Week 52 in mean 2-hour MMTT stimulated Cpeptide concentration
MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)
Measured: From Baseline to Week 52
Participant remaining C-peptide positive at Week 26 and Week 52
Incidence (yes/no) outcome Defined as mean 2-hour MMTT stimulated C-peptide concentration ≥0.2 nmol/L
Measured: Week 26 and Week 52
Time in range (TIR) (70-180 mg/dL) at Week 26 and Week 52
Assessed by Continuous glucose monitoring (CGM). A CGM system is a device that records interstitial glucose levels continuously throughout the day and night via a subcutaneous sensor.
Measured: Week 26 and Week 52
Change from baseline to Week 26 and Week 52 in insulin dose
Expressed in IU/kg/day
Measured: From Baseline to Week 26 and Week 52
Change from baseline to Week 26 and Week 52 in glycated hemoglobin A1c (HbA1c) level
Measured: From Baseline to Week 26 and Week 52
Participant having HbA1c ≤6.5% and ≤0.25 IU/kg/day of exogenous insulin required at Week 26 and Week 52
Incidence (yes/no) outcome
Measured: Week 26 and Week 52
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation
Measured: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of hypoglycemic events (level 2 or 3 according to American Diabetes Association)
Incidence (yes/no) outcome
Measured: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of hyperglycemic episodes (level 2 according to American Diabetes Association)
Incidence (yes/no) outcome
Measured: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of diabetic ketoacidosis (DKA) events
Incidence (yes/no) outcome
Measured: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation
Incidence (yes/no) outcome
Measured: Up to End of Study (approx. 83 Weeks)
Brivekimig serum concentrations over time
Measured: Up to End of Study (approx. 83 Weeks)
Incidence of anti-drug antibodies (ADAs) over time
Measured: Up to End of Study (approx. 83 Weeks)
Change from baseline to Week 26 and Week 52 in Problem Areas in Diabetes (PAID) total score (all participants)
The Problem Areas in Diabetes (PAID) is a diabetes specific instrument measuring diabetes distress. There is an adult version (18+) and a pediatric version for children 8-17 years of age. The PAID contains 20 items that describe negative emotions related to diabetes (eg, depression, anger, frustration). Item scores are summed to generate a total score. Scores range from 0 to 100, where higher total scores correspond to higher emotional distress due to diabetes
Measured: From Baseline to Week 26 and Week 52
Change from baseline to Week 26 and Week 52 in PAID immediate and theoretical domain scores (caregivers of all participants 12 to 17 y.o.)
Caregiver version of PAID for parents with children 8-18 years of age consists of 18 items that measure caregiver burden. Two scores are calculated: Immediate Burden and Theoretical Burden. Scores range from 0 to 100, where higher scores correspond to greater caregiver burden.
Measured: From Baseline to Week 26 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start28 Feb 2025
- Primary completion29 Apr 2027 (estimated)
- Study completion29 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812988
- Sponsor's protocol ID
- ACT18368
- Other IDs
- U1111-1307-7268
- Acronym
- T1D OBTAIN
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2a Study Assessing Safety and Efficacy of Brivekimig, a Dual Anti-TNF-α and Anti-OX40L NANOBODY® Molecule, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Recently Diagnosed Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06812988
- Acronym / sponsor ID
- T1D OBTAIN / ACT18368
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 29 Apr 2027 (estimated)
- Study completion
- 29 Apr 2027 (estimated)
- First posted
- 6 Feb 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 is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study.
The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) on insulin therapy.
The study design comprises 2 parts: in Part A adult participants (18 to 35 years of age at screening) and in Part B adolescent and young adult participants (age range 12 to 21 years) will be randomized into brivekimig and placebo groups. Approximately 84 participants will be included with randomization ratio 3:1 (active:placebo).
The study includes a screening period (3 to 5 weeks), a double-blind treatment period of 52 weeks and a safety follow-up of 26 weeks.
Detailed description
The total study duration will be up to 83 weeks including Screening and Safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brivekimig | Experimental | Drug: BrivekimigParticipants will receive subcutaneous injection of brivekimig. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive subcutaneous injection of matching placebo. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Participant must be 18 to 35 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part A. Participant must be 12 to 21 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part B.
- Participants who meet the criteria of T1D according to American Diabetes Association (ADA 2024).
- Initiated exogenous insulin replacement therapy not longer than 90 days prior to Screening visit at which random C-peptide will be assessed.
- Receiving insulin hormone replacement therapy:
- Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study Screening:
Key exclusion criteria (20 listed)
- Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or intravenous (IV) antibiotics or significant chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus [CMV], Epstein-Barr Virus [EBV] as determined at Screening), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during Screening.
- History of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution.
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing.
- Evidence of any clinically significant, severe or unstable, acute or, chronically progressive, uncontrolled infection, medical or surgical condition (eg, but not limited to, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, or any known immune deficiency), or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation).
- History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
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 |
|---|---|---|
| BrivekimigPharmaceutical form: Solution Route of administration: Subcutaneous injection | Drug | Brivekimig |
| PlaceboPharmaceutical form: Solution Route of administration: Subcutaneous injection | Drug | Placebo |
Primary outcome
Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration
Time frame: From Baseline to Week 26
Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)
15 secondary outcomes
Change from baseline to Week 52 in mean 2-hour MMTT stimulated Cpeptide concentration
Time frame: From Baseline to Week 52
Participant remaining C-peptide positive at Week 26 and Week 52
Time frame: Week 26 and Week 52
Time in range (TIR) (70-180 mg/dL) at Week 26 and Week 52
Time frame: Week 26 and Week 52
Change from baseline to Week 26 and Week 52 in insulin dose
Time frame: From Baseline to Week 26 and Week 52
Change from baseline to Week 26 and Week 52 in glycated hemoglobin A1c (HbA1c) level
Time frame: From Baseline to Week 26 and Week 52
Participant having HbA1c ≤6.5% and ≤0.25 IU/kg/day of exogenous insulin required at Week 26 and Week 52
Time frame: Week 26 and Week 52
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation
Time frame: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of hypoglycemic events (level 2 or 3 according to American Diabetes Association)
Time frame: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of hyperglycemic episodes (level 2 according to American Diabetes Association)
Time frame: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of diabetic ketoacidosis (DKA) events
Time frame: Up to End of Study (approx. 83 Weeks)
Incidence (yes/no) of clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation
Time frame: Up to End of Study (approx. 83 Weeks)
Brivekimig serum concentrations over time
Time frame: Up to End of Study (approx. 83 Weeks)
Incidence of anti-drug antibodies (ADAs) over time
Time frame: Up to End of Study (approx. 83 Weeks)
Change from baseline to Week 26 and Week 52 in Problem Areas in Diabetes (PAID) total score (all participants)
Time frame: From Baseline to Week 26 and Week 52
Change from baseline to Week 26 and Week 52 in PAID immediate and theoretical domain scores (caregivers of all participants 12 to 17 y.o.)
Time frame: From Baseline to Week 26 and Week 52
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 13 Mar 2026.
- ACT18368 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brivekimig in people with Type 1 Diabetes Mellitus, run by Sanofi at 24 sites in 8 countries.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Argentina, Australia, Chile, Israel and 3 more countries. 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration (time frame: From Baseline to Week 26). 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 13 Mar 2026.