NCT07088068 · Sanofi
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
(βETA PRESERVE)
What this study is about
This is a conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, parallel, compared against an inactive treatment Phase 3, 2-treatment group$1 study for treatment.
View original scientific description
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.
- Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria
- Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis
- Participants must be positive for at least one T1D autoantibody at screening:
- Glutamic acid decarboxylase (GAD-65),
- Insulinoma Antigen-2 (IA-2),
- Zinc-transporter 8 (ZnT8), or
- Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation).
- Islet cell cytoplasmic autoantibodies (ICAs)
- Have random C-peptide level ≥0.2 nmol/L obtained at screening
- Enter Inclusion Criteria Sex
- Both male and female participants are eligible.
- Contraceptive use by women should be consistent with local regulations regarding the methods of c
Where
- Scottsdale, Arizona
- Huntington Beach, California
- San Francisco, California
- Aurora, Colorado
- New Haven, Connecticut
- Gainesville, Florida
- Hollywood, Florida
- Tampa, Florida
- Winter Park, Florida
- Atlanta, Georgia
- Columbus, Georgia
- Stockbridge, Georgia
And 19 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations