AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 3βETA PRESERVENCT07088068

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

A Phase 3 study testing Teplizumab in people with Type 1 Diabetes Mellitus, run by Sanofi at 202 sites in 20 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 1 year to 25 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Teplizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
723 participants
Where
202 sitesin 20 countries
Study dates
6 Aug 2025to 12 Dec 2028
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 1 year to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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),
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  • 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 contraception for those participating in clinical studies.
  • A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies:
  • Is a woman of nonchildbearing potential (WONCBP) OR
  • Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1% during the study intervention period (to be effective before starting the intervention) and for at least 30 days after the last administration of study intervention.
  • A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and within 24 hours (urine or serum as required by local regulations) before the first administration of study intervention.
  • Lactating woman must interrupt breastfeeding and pump and discard breast milk during and for 20 days after last administration of study intervention.
  • Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
  • Note: For minor participants, a specific ICF must also be signed by the participant's legally authorized representative (LAR).

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.
  • Participant has an active serious infection and/or fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.
  • At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).
  • At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
  • Participant has 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. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
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  • Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of Investigator).
  • Any clinically significant abnormality identified either in medical/surgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse event (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.
  • Participant has recent or planned vaccinations as follows:
  • Live-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned/required administration during treatment or up to 26 weeks after last IMP administration in any treatment course
  • Inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.
  • Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin
  • Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including but not limited to systemic corticosteroids (ie, oral, high doses of inhaled or injectable) with duration >14 days, adrenocorticotropic hormone, verapamil).
  • Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.
  • Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).
  • Participant has previously received teplizumab or other anti-CD3 treatment.
  • Other medications not compatible or interfering with IMP at discretion of Investigator.
  • Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 8 weeks or 5 half-lifes, whichever is longer, prior to screening.
  • Participant has any of the following laboratory parameters, at screening prior to first dose:
  • Lymphocyte count: <1000/µL,
  • Neutrophil count: <1500/µL (< 1000 /µL in participants with documented Duffy-null genotype),
  • Platelet count: <150,000 platelets/µL,
  • Hemoglobin: <10 g/dL,
  • Aspartate aminotransferase (AST) >2.0 × upper limit of normal (ULN),
  • Alanine aminotransferase (ALT) >2.0 × ULN,
  • Total bilirubin >1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

202 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

contact-us@sanofi.com

202 sites in 20 countries

United States34 sites, 34 recruiting

  • C.S. Mott Children's Hospital- Site Number : 8400015

    Ann Arbor, Michigan, 48109

    Recruiting

  • Asheville Clinical Research- Site Number : 8400045

    Asheville, North Carolina, 28803

    Recruiting

  • Atlanta Diabetes Associates- Site Number : 8400036

    Atlanta, Georgia, 30318

    Recruiting

  • Children's Healthcare of Atlanta - Egleston Hospital- Site Number : 8400065

    Atlanta, Georgia, 30322

    Recruiting

  • Barbara Davis Center for Childhood Diabetes- Site Number : 8400031

    Aurora, Colorado, 80045

    Recruiting

  • AM Diabetes & Endocrinology Center- Site Number : 8400004

    Bartlett, Tennessee, 38133

    Recruiting

  • St. Luke's Children's Hospital- Site Number : 8400014

    Boise, Idaho, 83712

    Recruiting

  • University At Buffalo - Jacobs School Of Medicine- Site Number : 8400006

    Buffalo, New York, 14203

    Recruiting

  • UNC Children's Hospital- Site Number : 8400034

    Chapel Hill, North Carolina, 27599

    Recruiting

  • Uva Children's Battle Building- Site Number : 8400060

    Charlottesville, Virginia, 22903

    Recruiting

  • Cincinnati Children's Hospital Medical Center- Site Number : 8400018

    Cincinnati, Ohio, 45229

    Recruiting

  • IACT Health - Columbus - Talbotton Road- Site Number : 8400003

    Columbus, Georgia, 31904

    Recruiting

  • The Ohio State University- Site Number : 8400051

    Columbus, Ohio, 43210

    Recruiting

  • University of Florida College of Medicine- Site Number : 8400054

    Gainesville, Florida, 32610

    Recruiting

  • Encore Medical Research - Hollywood- Site Number : 8400061

    Hollywood, Florida, 33024

    Recruiting

  • Baylor College of Medicine- Site Number : 8400057

    Houston, Texas, 77030

    Recruiting

  • Rocky Mountain Clinical Research - Idaho Falls- Site Number : 8400001

    Idaho Falls, Idaho, 83404

    Recruiting

  • Nemours Children's Speciality Care- Jacksonville- Site Number : 8400040

    Jacksonville, Florida, 32207

    Recruiting

  • Children's Mercy Adelle Hall Campus- Site Number : 8400010

    Kansas City, Missouri, 64108

    Recruiting

  • Norton Children's Research Institute - Wendy Novak Diabetes Institute- Site Number : 8400016

    Louisville, Kentucky, 40202

    Recruiting

  • Yale University School of Medicine- Site Number : 8400005

    New Haven, Connecticut, 06510

    Recruiting

  • Endocrine Associates of West Village- Site Number : 8400064

    New York, New York, 10001

    Recruiting

  • Columbia University Irving Medical Center- Site Number : 8400009

    New York, New York, 10032

    Recruiting

  • The Children's Hospital of Philadelphia- Site Number : 8400039

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400019

    Rochester, Minnesota, 55905

    Recruiting

  • Park Nicollet Institute - Oncology Research- Site Number : 8400059

    Saint Louis Park, Minnesota, 55426

    Recruiting

  • University of Utah Health Hospital- Site Number : 8400052

    Salt Lake City, Utah, 84132

    Recruiting

  • Rady Children's Hospital- Site Number : 8400002

    San Diego, California, 92123

    Recruiting

  • University of California San Francisco - Mission Bay- Site Number : 8400011

    San Francisco, California, 94158

    Recruiting

  • Scottsdale Clinical Trials- Site Number : 8400044

    Scottsdale, Arizona, 85260

    Recruiting

  • Benaroya Research Institute at Virginia Mason- Site Number : 8400038

    Seattle, Washington, 98101

    Recruiting

  • MultiCare Mary Bridge Children's Health Center- Site Number : 8400037

    Tacoma, Washington, 98405

    Recruiting

  • University of South Florida- Site Number : 8400013

    Tampa, Florida, 33612

    Recruiting

  • AdventHealth Winter Park- Site Number : 8400033

    Winter Park, Florida, 32792

    Recruiting

Other trials in United States

China34 sites, 34 recruiting

  • Investigational Site Number : 1560035

    Beijing, 100020

    Recruiting

  • Investigational Site Number : 1560003

    Beijing, 100034

    Recruiting

  • Investigational Site Number : 1560033

    Beijing, 100045

    Recruiting

  • Investigational Site Number : 1560009

    Changchun, 130041

    Recruiting

  • Investigational Site Number : 1560001

    Changsha, 410011

    Recruiting

  • Investigational Site Number : 1560055

    Chengdu, 610072

    Recruiting

  • Investigational Site Number : 1560042

    Chengdu, 610091

    Recruiting

  • Investigational Site Number : 1560007

    Guangzhou, 510120

    Recruiting

  • Investigational Site Number : 1560037

    Guangzhou, 510620

    Recruiting

  • Investigational Site Number : 1560040

    Hangzhou, 310003

    Recruiting

  • Investigational Site Number : 1560014

    Hangzhou, 310009

    Recruiting

  • Investigational Site Number : 1560012

    Hangzhou, 310014

    Recruiting

  • Investigational Site Number : 1560010

    Harbin, 150001

    Recruiting

  • Investigational Site Number : 1560026

    Hohhot, 010050

    Recruiting

  • Investigational Site Number : 1560059

    Jinan, 250001

    Recruiting

  • Investigational Site Number : 1560056

    Lanzhou, 730000

    Recruiting

  • Investigational Site Number : 1560016

    Luoyang, 471003

    Recruiting

  • Investigational Site Number : 1560018

    Nanchang, 330006

    Recruiting

  • Investigational Site Number : 1560043

    Nanchang, 330038

    Recruiting

  • Investigational Site Number : 1560005

    Nanjing, 210008

    Recruiting

  • Investigational Site Number : 1560034

    Nanjing, 210008

    Recruiting

  • Investigational Site Number : 1560054

    Nanjing, 210029

    Recruiting

  • Investigational Site Number : 1560050

    Pingxiang, 337055

    Recruiting

  • Investigational Site Number : 1560031

    Shanghai, 200032

    Recruiting

  • Investigational Site Number : 1560032

    Shanghai, 200040

    Recruiting

  • Investigational Site Number : 1560013

    Shenyang, 110004

    Recruiting

  • Investigational Site Number : 1560045

    Shenzhen, 518026

    Recruiting

  • Investigational Site Number : 1560019

    Tianjin, 300052

    Recruiting

  • Investigational Site Number : 1560039

    Wuhan, 430010

    Recruiting

  • Investigational Site Number : 1560002

    Wuhan, 430030

    Recruiting

  • Investigational Site Number : 1560041

    Wuxi, 214023

    Recruiting

  • Investigational Site Number : 1560060

    Yueyang, 414000

    Recruiting

  • Investigational Site Number : 1560038

    Zhengzhou, 450018

    Recruiting

  • Investigational Site Number : 1560027

    Zhenjiang, 212000

    Recruiting

Other trials in China

Japan21 sites, 21 recruiting

  • Investigational Site Number : 3920011

    Azumino, Nagano, 399-8288

    Recruiting

  • Investigational Site Number : 3920022

    Chiba, 266-0007

    Recruiting

  • Investigational Site Number : 3920005

    Fukuoka, 813-0017

    Recruiting

  • Investigational Site Number : 3920025

    Iruma, Saitama, 350-0495

    Recruiting

  • Investigational Site Number : 3920003

    Kobe, Hyōgo, 650-0017

    Recruiting

  • Investigational Site Number : 3920007

    Koshigaya, Saitama, 343-0845

    Recruiting

  • Investigational Site Number : 3920015

    Kyoto, 606-8507

    Recruiting

  • Investigational Site Number : 3920010

    Moriyama, Shiga, 524-8524

    Recruiting

  • Investigational Site Number : 3920020

    Nagoya, Aichi-ken, 453-8511

    Recruiting

  • Investigational Site Number : 3920017

    Nara, 630-8581

    Recruiting

  • Investigational Site Number : 3920006

    Niigata, 951-8520

    Recruiting

  • Investigational Site Number : 3920002

    Osaka, 545-8586

    Recruiting

  • Investigational Site Number : 3920001

    Sapporo, Hokkaido, 060-8543

    Recruiting

  • Investigational Site Number : 3920008

    Shimajiri, Okinawa, 901-1303

    Recruiting

  • Investigational Site Number : 3920012

    Shizuoka, 420-0953

    Recruiting

  • Investigational Site Number : 3920013

    Tokyo, 101-8309

    Recruiting

  • Investigational Site Number : 3920014

    Tokyo, 105-8461

    Recruiting

  • Investigational Site Number : 3920021

    Tokyo, 113-0033

    Recruiting

  • Investigational Site Number : 3920026

    Tokyo, 157-8535

    Recruiting

  • Investigational Site Number : 3920016

    Tokyo, 162-8655

    Recruiting

  • Investigational Site Number : 3920023

    Yokohama, Kanagawa, 232-0024

    Recruiting

Other trials in Japan

Spain18 sites, 18 recruiting

  • Investigational Site Number : 7240023

    Alcalá de Henares, Madrid, 28805

    Recruiting

  • Investigational Site Number : 7240017

    Barcelona, Catalunya [Cataluña], 08035

    Recruiting

  • Investigational Site Number : 7240020

    Bizkaia, Basque Country, 48903

    Recruiting

  • Investigational Site Number : 7240004

    Esplugues de Llobregat, Barcelona [Barcelona], 08950

    Recruiting

  • Investigational Site Number : 7240009

    Madrid, Madrid, Comunidad de, 28034

    Recruiting

  • Investigational Site Number : 7240011

    Madrid, Madrid, Comunidad de, 28040

    Recruiting

  • Investigational Site Number : 7240007

    Madrid, Madrid, Comunidad de, 28046

    Recruiting

  • Investigational Site Number : 7240006

    Madrid, 28007

    Recruiting

  • Investigational Site Number : 7240010

    Madrid, 28009

    Recruiting

  • Investigational Site Number : 7240022

    Málaga, 29010

    Recruiting

  • Investigational Site Number : 7240015

    Palma, 07120

    Recruiting

  • Investigational Site Number : 7240016

    Pamplona, Navarre, 31008

    Recruiting

  • Investigational Site Number : 7240003

    Sabadell, 08208

    Recruiting

  • Investigational Site Number : 7240019

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

    Recruiting

  • Investigational Site Number : 7240012

    Santiago de Compostela, A Coruña [La Coruña], 15706

    Recruiting

  • Investigational Site Number : 7240001

    Seville, Andalusia, 41013

    Recruiting

  • Investigational Site Number : 7240021

    Seville, Sevilla, 41009

    Recruiting

  • Investigational Site Number : 7240014

    Vigo, Pontevedra [Pontevedra], 36312

    Recruiting

Other trials in Spain

Italy13 sites, 13 recruiting

  • Investigational Site Number : 3800004

    Bologna, 40138

    Recruiting

  • Investigational Site Number : 3800001

    Florence, Firenze, 50139

    Recruiting

  • Investigational Site Number : 3800008

    Genoa, Genova, 16147

    Recruiting

  • Investigational Site Number : 3800014

    Messina, 98125

    Recruiting

  • Investigational Site Number : 3800005

    Milan, Milano, 20154

    Recruiting

  • Investigational Site Number : 3800011

    Milan, Milano, 20157

    Recruiting

  • Investigational Site Number : 3800015

    Novara, 28100

    Recruiting

  • Investigational Site Number : 3800016

    Pescara, 65100

    Recruiting

  • Investigational Site Number : 3800012

    Rome, Roma, 00161

    Recruiting

  • Investigational Site Number : 3800003

    Rome, Roma, 00165

    Recruiting

  • Investigational Site Number : 3800013

    Siena, 53100

    Recruiting

  • Investigational Site Number : 3800010

    Turin, Torino, 10126

    Recruiting

  • Investigational Site Number : 3800002

    Verona, 37126

    Recruiting

Other trials in Italy

United Kingdom11 sites, 11 recruiting

  • Investigational Site Number : 8260011

    Bath, Somerset, BA1 3NG

    Recruiting

  • Investigational Site Number : 8260001

    Cambridge, Cambridgeshire, CB2 2QQ

    Recruiting

  • Investigational Site Number : 8260004

    Dundee, Dundee City, DD1 9SY

    Recruiting

  • Investigational Site Number : 8260002

    Glasgow, Glasgow City, G51 4TF

    Recruiting

  • Investigational Site Number : 8260006

    Guildford, Surrey, GU2 7XX

    Recruiting

  • Investigational Site Number : 8260005

    Leeds, LS9 7TF

    Recruiting

  • Investigational Site Number : 8260009

    London, England, E1 1BB

    Recruiting

  • Investigational Site Number : 8260012

    London, England, SW10 9NH

    Recruiting

  • Investigational Site Number : 8260007

    London, London, City of, SE5 9RL

    Recruiting

  • Investigational Site Number : 8260010

    Reading, RG1 5AN

    Recruiting

  • Investigational Site Number : 8260003

    Sheffield, S10 2TH

    Recruiting

Other trials in United Kingdom

France9 sites, 9 recruiting

  • Investigational Site Number : 2500004

    Bron, 69500

    Recruiting

  • Investigational Site Number : 2500010

    La Tronche, 38700

    Recruiting

  • Investigational Site Number : 2500011

    Lille, 59037

    Recruiting

  • Investigational Site Number : 2500002

    Paris, 75010

    Recruiting

  • Investigational Site Number : 2500008

    Paris, 75013

    Recruiting

  • Investigational Site Number : 2500001

    Paris, 75015

    Recruiting

  • Investigational Site Number : 2500009

    Paris, 75019

    Recruiting

  • Investigational Site Number : 2500005

    Pau, 64000

    Recruiting

  • Investigational Site Number : 2500007

    Strasbourg, 67000

    Recruiting

Other trials in France

Germany9 sites, 9 recruiting

  • Investigational Site Number : 2760002

    Augsburg, 86156

    Recruiting

  • Investigational Site Number : 2760008

    Bielefeld, 33617

    Recruiting

  • Investigational Site Number : 2760007

    Dresden, 01307

    Recruiting

  • Investigational Site Number : 2760012

    Frankfurt, 60590

    Recruiting

  • Investigational Site Number : 2760003

    Freiburg im Breisgau, 79106

    Recruiting

  • Investigational Site Number : 2760005

    Hanover, 30173

    Recruiting

  • Investigational Site Number : 2760006

    Leipzig, 04103

    Recruiting

  • Investigational Site Number : 2760010

    Munich, 81675

    Recruiting

  • Investigational Site Number : 2760001

    Ulm, 89081

    Recruiting

Other trials in Germany

Belgium8 sites, 8 recruiting

  • Investigational Site Number : 0560005

    Brussels, 1020

    Recruiting

  • Investigational Site Number : 0560009

    Brussels, 1070

    Recruiting

  • Investigational Site Number : 0560007

    Edegem, 2650

    Recruiting

  • Investigational Site Number : 0560002

    Jette, 1090

    Recruiting

  • Investigational Site Number : 0560001

    Leuven, 3000

    Recruiting

  • Investigational Site Number : 0560008

    Leuven, 3000

    Recruiting

  • Investigational Site Number : 0560006

    Liège, 4000

    Recruiting

  • Investigational Site Number : 0560004

    Namur, 5000

    Recruiting

Other trials in Belgium

Brazil7 sites, 7 recruiting

  • Centro de Diabetes Curitiba- Site Number : 0760006

    Curitiba, Paraná, 80810-040

    Recruiting

  • Hospital Universitario Walter Cantidio- Site Number : 0760009

    Fortaleza, Ceará, 60430-270

    Recruiting

  • Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002

    Marília, São Paulo, 17504-072

    Recruiting

  • Hospital Universitario Clementino Fraga Filho- Site Number : 0760008

    Rio de Janeiro, 21941-913

    Recruiting

  • Centro de Pesquisas Clínicas - São Paulo- Site Number : 0760011

    São Paulo, 01228-200

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012

    São Paulo, 05403-000

    Recruiting

  • Hospital Israelita Albert Einstein- Site Number : 0760001

    São Paulo, 05651-901

    Recruiting

Other trials in Brazil

Argentina6 sites, 6 recruiting

  • Investigational Site Number : 0320005

    Buenos Aires, 1419

    Recruiting

  • Investigational Site Number : 0320013

    Córdoba, 5004

    Recruiting

  • Investigational Site Number : 0320008

    Mar del Plata, Buenos Aires, 7600

    Recruiting

  • Investigational Site Number : 0320002

    Salta, 4400

    Recruiting

  • Investigational Site Number : 0320003

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

  • Investigational Site Number : 0320012

    Santa Fe, 3000

    Recruiting

Other trials in Argentina

Israel6 sites, 6 recruiting

  • Investigational Site Number : 3760005

    Jerusalem, 9112001

    Recruiting

  • Investigational Site Number : 3760002

    Petah Tikva, 4920235

    Recruiting

  • Investigational Site Number : 3760003

    Petah Tikva, 4941492

    Recruiting

  • Investigational Site Number : 3760001

    Ramat Gan, 5262100

    Recruiting

  • Investigational Site Number : 3760006

    Rehovot, 7610001

    Recruiting

  • Investigational Site Number : 3760004

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Poland6 sites, 6 recruiting

  • Investigational Site Number : 6160006

    Bialystok, 15-274

    Recruiting

  • Investigational Site Number : 6160005

    Lodz, Lódzkie, 92-213

    Recruiting

  • Investigational Site Number : 6160004

    Lublin, Lublin Voivodeship, 20-601

    Recruiting

  • Investigational Site Number : 6160008

    Warsaw, Masovian Voivodeship, 02-097

    Recruiting

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-117

    Recruiting

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 04-746

    Recruiting

Other trials in Poland

Canada4 sites, 4 recruiting

  • Investigational Site Number : 1240008

    Calgary, Alberta, T2N 4L7

    Recruiting

  • Investigational Site Number : 1240002

    Halifax, Nova Scotia, B3H 2Y9

    Recruiting

  • Investigational Site Number : 1240007

    Ottawa, Ontario, K1H 8L1

    Recruiting

  • Investigational Site Number : 1240009

    Vancouver, British Columbia, V5Z 1M9

    Recruiting

Other trials in Canada

Greece4 sites, 4 recruiting

  • Investigational Site Number : 3000005

    Athens, 115 27

    Recruiting

  • Investigational Site Number : 3000001

    Athens, 115 28

    Recruiting

  • Investigational Site Number : 3000004

    Athens, 124 62

    Recruiting

  • Investigational Site Number : 3000003

    Thessaloniki, 546 42

    Recruiting

Other trials in Greece

Australia3 sites, 3 recruiting

  • Investigational Site Number : 0360003

    Adelaide, South Australia, 5006

    Recruiting

  • Investigational Site Number : 0360001

    Brisbane, Queensland, 4101

    Recruiting

  • Investigational Site Number : 0360002

    Perth, Western Australia, 6009

    Recruiting

Other trials in Australia

Czechia3 sites, 3 recruiting

  • Investigational Site Number : 2030004

    Prague, 128 08

    Recruiting

  • Investigational Site Number : 2030003

    Prague, 140 21

    Recruiting

  • Investigational Site Number : 2030001

    Prague, 150 06

    Recruiting

Other trials in Czechia

Netherlands3 sites, 3 recruiting

  • Investigational Site Number : 5280003

    Amersfoort, 3813 TZ

    Recruiting

  • Investigational Site Number : 5280002

    Leiden, 2333 ZA

    Recruiting

  • Investigational Site Number : 5280001

    Rotterdam, 3011 TA

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Romania2 sites, 2 recruiting

  • Investigational Site Number : 6420001

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    Recruiting

  • Investigational Site Number : 6420003

    Iași, 700514

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Switzerland1 site, 1 recruiting

  • Investigational Site Number : 7560002

    Basel, 4005

    Recruiting

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About this study

Official title: A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

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.

Read the detailed description

The study duration for one participant will be approximately 84 weeks (19 months).

Being tested
Teplizumab, 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.

  • TeplizumabDrug

    Also called SAR446681, TZIELD

    Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

  • PlaceboOther

    Pharmaceutical form: Concentrated solution for infusion Route of administration: Intravenous infusion

Study groups in NCT07088068
Study groupRoleWhat they receive
TeplizumabExperimentalParticipants will receive teplizumab in increasing doses by intravenous administration
Receives: Drug: Teplizumab
PlaceboPlacebo comparatorParticipants will receive volume matching placebo doses to the Teplizumab arm by intravenous administration
Receives: Other: Placebo

What is being measured

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

  1. For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline

    Measured: From Baseline to Week 52

  2. For US and non-EU countries: Total number of days without prandial insulin use

    Measured: From baseline to Week 52

  3. For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older

    Measured: From baseline to Week 52

  4. For EU countries: HbA1c change from baseline

    Measured: From baseline to Week 52

  5. For EU countries: Total number of days without prandial insulin use

    Measured: From baseline to Week 52

Secondary outcomes (9)

  1. Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC

    Measured: From baseline to Week 52

  2. Participants remaining C-peptide positive (2 hours MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L)

    Measured: At Week 52

  3. Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin

    Measured: At Week 52

  4. Change from baseline in Time-in-Range (TIR) (70-180 mg/dL blood glucose) assessed by continuous glucose monitoring (CGM)

    Measured: From baseline to Week 52

  5. Number of level 2 and 3 (according to American Diabetes Association) hypoglycemic events per participant year (event rates)

    Measured: From baseline to week 52

  6. Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation

    Measured: From baseline to week 78

  7. Teplizumab PK parameters: Maximum concentration of teplizumab [Cmax]

    Measured: From baseline to Week 30

  8. Teplizumab PK parameters: Area under the curve [AUC] and [AUClast]

    Measured: From baseline to Week 30

  9. Incidence of antidrug-antibodies (ADAs)

    Measured: From baseline to week 78

Timeline

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

  1. First posted28 Jul 2025
  2. Study start6 Aug 2025
  3. Primary completion6 Jun 2028 (estimated)
  4. Study completion12 Dec 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
723 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07088068
Sponsor's protocol ID
EFC18241
Other IDs
2024-519494-19, U1111-1306-7316
Acronym
βETA PRESERVE
Status last verified
Oct 2026
First submitted
20 Jul 2025
Last updated
13 Oct 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teplizumab in people with Type 1 Diabetes Mellitus, run by Sanofi at 202 sites in 20 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 21 inclusion and 27 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 13 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 202 sites in United States, China, Japan, Spain, Italy and 15 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 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 Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline (time frame: From Baseline to Week 52). The study lists 5 primary outcomes in all. 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 NCT07088068.

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 Oct 2026.

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