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Type 1 DiabetesPhase 1/2WAVE T1DNCT07061574

A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes

A Phase 1/2 study testing Anti-thymocyte globulin (ATG), verapamil extended-release capsule and Adalimumab in people with Type 1 Diabetes and New Onset, run by City of Hope Medical Center at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to <21 with recent-onset stage 3 T1D. Read more about this study

Who is it for?
Ages 9 to 20 years
Conditions the study is for
Type 1 Diabetes, New Onset
What is being tested?
Anti-thymocyte globulin (ATG), verapamil extended-release capsule and Adalimumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
11 sitesUnited States
Study dates
10 Mar 2026to 15 Apr 2031
Phase
Phase 1/2
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 9 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.
  • At least one positive T1D auto-antibody.
  • If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.
  • Insulin auto-antibodies are only considered if exogenous insulin use is <10 days when blood is drawn.
  • Must have stimulated C-peptide levels ≥0.2 pmol/mL (≥0.6 ng/mL) measured during MMTT conducted prior to randomization.
  • Age 9 to <21 years at the time of randomization.
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  • Body weight >30kg.
  • BMI <95th percentile for age and gender.
  • Willing to comply with intensive diabetes management.
  • Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.
  • Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral/injection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.
  • Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.
  • Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment.
  • Willing to provide informed consent and child assent as applicable.
  • Willing to provide their primary endocrinologist's contact information and have their primary endocrinologist notified of their participation
  • Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form.
  • Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable).
  • Must be fully vaccinated for age.
  • Must have been vaccinated for flu (if currently in flu season).
  • Must be willing to not receive live vaccines throughout the treatment period.
  • Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening.

Who cannot join

  • Prior treatment with ATG or known allergy to ATG or rabbit-derived products.
  • Local lab draw at screening:
  • Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (<3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL).
  • Thrombocytopenia (<100,000 platelets/μL) or anemia (hemoglobin < 10g/dL).
  • Leukocytosis (>14,000/μL)
  • Infections:
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  • Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization.
  • Have active signs or symptoms of acute infection at the time of randomization.
  • Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON-TB Gold), or a positive test for latent tuberculosis.
  • Have evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.
  • History of serious bacterial, viral, fungal, or other opportunistic infections.
  • Have active signs or symptoms of CMV or EBV compatible illness lasting more than 7 days within 30 days of randomization.
  • Have positive CMV and/or EBV PCR test within 30 days prior to randomization.
  • Have positive COVID-19 self-antigen test within 3 days of randomization.
  • History of underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (e.g. AV block, accessory pathway such as Wolff- Parkinson-White or Lown-Ganong-Levine syndromes) or abnormal ECG (unless cleared by cardiology).
  • Blood pressure (either systolic or diastolic) <5th percentile for age, gender, and height on two out of three measurements.
  • Pulse <2.5th percentile for age and gender on two out of three measurements.
  • History of vasovagal syncopal episodes related to hypotension.
  • History of malignancies other than of skin.
  • Use of medications likely to interfere with study results:
  • Any immunomodulators, including systemic steroids or participation in prior research study in which a potential participant received an immunomodulatory agent (may participate if received placebo only).
  • Current or previous use of Teplizumab, Adalimumab, or Verapamil.
  • Ongoing use of medications known to influence glycemia or glucose tolerance. Only topical steroids are allowed.
  • Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine.
  • Receipt of live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guerin, and smallpox) within the 90 days before randomization.
  • Any known hypersensitivity reaction to any of the study medications or their components.
  • Unable to swallow pills (tested with an inert imitation tablet in clinic at screening).
  • History of significant allergy (e.g., anaphylaxis) to milk or soy proteins in the Boost drink required for study MMTT testing.
  • Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor).
  • Established history of allergy or severe reaction to adhesive or tape that must be used in the study.
  • Participation in another treatment research study that involves diabetes care or immune modulation, unless the participant is able to confirm that they were in the placebo arm.
  • Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:
  • Alcohol or drug abuse
  • Untreated or inadequately treated mental illness
  • Liver disease or LFTs >2x ULN.
  • Renal disease or creatinine greater than 1.5x ULN.
  • Other autoimmune diseases except for stable and treated hypothyroidism Graves' disease, or celiac disease (e.g., symptom-free on a gluten free diet).
  • Nervous system disorder including but not limited to Guillain-Barre Syndrome, multiple sclerosis, progressive multifocal leukoencephalopathy.
  • History of multiple abdominal surgeries and/or at increased risk for bowel obstruction.
  • Any clinical or laboratory conditions that the investigator feels would interfere with the study or participant safety (e.g., increased risk to pre-existing disease).
  • Any lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.
  • -

Trial locations and contacts

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

Robert Henderson, MS contact

813-975-8690

rhenderson@jaeb.org

11 sites in 1 country

United States11 sites, 11 recruiting

  • University of Buffalo

    Buffalo, New York, 14203

    Amanda House, 716-323-0075, ahouse@upa.chob.edu

    Teresa Quattrin, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Danielle J. Poulton, 352-294-5760, danielle.poulton@peds.ufl.edu

    Laura Jacobsen, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Marion J Valladares, 832-824-9316, Marion.Valladares@bcm.edu

    Rebecca Aguirre, MD, PhD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Hannah Lease, 317-278-4874, hlease@iu.edu

    Linda DiMeglio, MD, MPH

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Angela Martinez, 3108250867, angelamartinez@mednet.ucla.edu

    Christina Reh, MD

    Not yet recruiting

  • University of Miami

    Miami, Florida, 33136

    Danay Saavedra, 305-243-7740, dxs4415@med.miami.edu

    David Baidal

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Shannon Beasley, 612-625-5609, beasl103@umn.edu

    Antoinette Moran, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06511

    Amy Steffen, 203-737-8852, amy.steffen@yale.edu

    Laura Nally, MD

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Kelli DeLallo, 412-692-5210, elli.delallo@chp.edu

    Ingrid Libman, MD

    Recruiting

  • UCSF

    San Francisco, California, 94143

    Rebecca Wesch, 415-476-5984, rebecca.wesch@ucsf.edu

    Stephen Gitelman, MD

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Kevin Bocek, 206-643-5599, Kevin.Bocek@seattlechildrens.org

    Petter Bjornstad, MD

    Recruiting

Other trials in United States

About this study

This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to <21 with recent-onset stage 3 T1D.

Read the detailed description

The primary objective of this study is to assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons with T1D. The secondary objectives are to assess metabolic and safety endpoints at 2 years and at timepoints between baseline and two years.

Being tested
Anti-thymocyte globulin (ATG), verapamil extended-release capsule, Adalimumab
Keywords
ATG, Verapamil, Adalimumab
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.

  • Anti-thymocyte globulin (ATG)Drug

    Also called Thymoglobulin

    ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. The first dose (0.5 mg/kg) will be infused on day 0, during a period of 6 hours. The second dose (2 mg/kg) will be given on day 1, over a period of 4 to 6 hours.

  • verapamil extended-release capsuleDrug

    Daily oral (pill) administration at 60, 120, 240 or 360 mg based on weight and ECG findings.

  • AdalimumabDrug

    Also called Simlandi

    40 mg administered subcutaneously every other week beginning 6 weeks after the last dose of ATG until the 156-week visit.

Study groups in NCT07061574
Study groupRoleWhat they receive
ATG + PlaceboPlacebo comparatorATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2). This group will receive Verapamil (Oral) placebo or Adalimumab (injectable) placebo.
Receives: Drug: Anti-thymocyte globulin (ATG)
ATG + VerapamilExperimentalLow dose ATG (0.5 mg/kg Day 1 then 2 mg/kg Day 2). From the 6-week visit until the 156-week visit, daily oral administration at 60, 120, 240 or 360 mg based on weight and ECG findings.
Receives: Drug: verapamil extended-release capsule
ATG + AdalimumabExperimentalLow dose ATG (0.5 mg/kg Day 1 then 2 mg/kg Day 2). From the 6-week visit until the 156-week visit, Participants will receive a 40 mg dose injection every other week.
Receives: Drug: Adalimumab

What is being measured

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

  1. Stimulated C-peptide AUC

    The primary outcome is the C-peptide in response to a 2-hour MMTT at week 104. This is measured as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over 120 minutes.

    Measured: Week 104

Secondary outcomes (6)

  1. Severe Adverse Events

    Prevalence of SAE of grade 3 or above, that may be attributable to study medications at all follow-up time points.

    Measured: week13, week 26, week 52, week 78, and week 104

  2. Adverse Events

    Number and severity of AEs.

    Measured: Week 104

  3. Severe Hypoglycemia

    Rate of severe hypoglycemia, defined as an event requiring assistance of another person due to altered consciousness and another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

    Measured: Week 104

  4. Diabetic ketoacidosis (DKA)

    Number of DKA events (rate assessed if sufficient events)

    Measured: Week 104

  5. Number of Participants with CD4 count <500 mm3

    Frequency of CD4 count <500 mm3

    Measured: Week 104

  6. Number of Participants with Total Lymphocyte count <800/mm3

    Frequency of Total Lymphocyte count <800/mm3

    Measured: Week 104

Timeline

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

  1. First posted11 Jul 2025
  2. Study start10 Mar 2026
  3. Primary completion15 Apr 2030 (estimated)
  4. Study completion15 Apr 2031 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-center, randomized, double blind, placebo-controlled phase 1/2 clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061574
Sponsor's protocol ID
24745
Acronym
WAVE T1D
Status last verified
Oct 2026
First submitted
2 Jul 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Undecided yet

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anti-thymocyte globulin (ATG), verapamil extended-release capsule and Adalimumab in people with Type 1 Diabetes and New Onset, run by City of Hope Medical Center at 11 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 21 inclusion and 42 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Robert Henderson, MS (813-975-8690, rhenderson@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stimulated C-peptide AUC (time frame: Week 104). 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 NCT07061574.

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 16 Oct 2026.

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WAVE T1D Clinical Trial NCT07061574 | AzTrials