New drug aims to help type 1 diabetes patients keep making insulin

NCT ID NCT06111586

Ongoing Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This phase 2b trial tests frexalimab, an antibody that calms the immune system, in 192 adults and teens newly diagnosed with type 1 diabetes. The goal is to see if it can preserve the body's ability to produce insulin, reducing reliance on injections. Participants receive frexalimab or placebo for up to 104 weeks, with regular monitoring of insulin production and blood sugar control.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: frexalimab (a monoclonal antibody that blocks CD40L to calm the immune system)
What this could lead to: If it works, this could help people with newly diagnosed type 1 diabetes keep making some of their own insulin longer, reducing how much insulin they need to inject.
What could go wrong: This is a mid-stage trial with only 192 people, so results may not apply to everyone. The drug may not preserve insulin production better than placebo, and there are risks from immune suppression, such as infections.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TYPE 1 DIABETES MELLITUS

Contacts and locations

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Locations

AOU delle Marche - Ospedale G. Salesi-Site Number : 3800008

Torette, Ancona, 60020, Italy
AdventHealth Orlando- Site Number : 8400002

Orlando, Florida, 32803, United States
Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009

Naples, Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004

Verona, 37126, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003

Florence, Firenze, 50139, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001

Novara, 28100, Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002

Varese, 21100, Italy
Benaroya Research Institute at Virginia Mason- Site Number : 8400016

Seattle, Washington, 98101, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400019

Cincinnati, Ohio, 45229, United States
IRCCS Ospedale San Raffaele-Site Number : 3800006

Milan, Milano, 20132, Italy
Investigational Site Number : 0400001

Vienna, 1090, Austria
Investigational Site Number : 0400002

Graz, 8036, Austria
Investigational Site Number : 0400004

Linz, 4020, Austria
Investigational Site Number : 0560001

Leuven, 3000, Belgium
Investigational Site Number : 0560002

Brussels, 1090, Belgium
Investigational Site Number : 1240001

Vancouver, British Columbia, V5Y 3W2, Canada
Investigational Site Number : 1240003

Montreal, Quebec, H4A 3T2, Canada
Investigational Site Number : 1240004

Montreal, Quebec, H4a 3j1, Canada
Investigational Site Number : 1240005

Montreal, Quebec, H3T 1C5, Canada
Investigational Site Number : 1240007

London, Ontario, N6a 4l6, Canada
Investigational Site Number : 2030001

Prague, 150 06, Czechia
Investigational Site Number : 2030002

Prague, 100 34, Czechia
Investigational Site Number : 2030003

Ostrava, 708 52, Czechia
Investigational Site Number : 2080005

Herlev, 2730, Denmark
Investigational Site Number : 2460001

Helsinki, 00029, Finland
Investigational Site Number : 2460002

Turku, 20521, Finland
Investigational Site Number : 2460003

Tampere, 33520, Finland
Investigational Site Number : 2460004

Oulu, 90220, Finland
Investigational Site Number : 2500003

Saint-Herblain, 44800, France
Investigational Site Number : 2500004

Corbeil-Essonnes, 91106, France
Investigational Site Number : 2500005

Mont-de-Marsan, 40024, France
Investigational Site Number : 2500006

Paris, 75679, France
Investigational Site Number : 2500007

Pontoise, 95300, France
Investigational Site Number : 2760001

Hanover, 30173, Germany
Investigational Site Number : 2760002

Oldenburg in Holstein, 23758, Germany
Investigational Site Number : 2760003

Dresden, 01307, Germany
Investigational Site Number : 2760004

Ulm, 89081, Germany
Investigational Site Number : 3480001

Balatonfüred, 8230, Hungary
Investigational Site Number : 3480002

Nyíregyháza, 4400, Hungary
Investigational Site Number : 3480003

Nyíregyháza, 4400, Hungary
Investigational Site Number : 3480004

Budapest, 1089, Hungary
Investigational Site Number : 3480006

Székesfehérvár, 8000, Hungary
Investigational Site Number : 6160002

Katowice, Silesian Voivodeship, 40-752, Poland
Investigational Site Number : 6160004

Warsaw, Masovian Voivodeship, 02-117, Poland
Investigational Site Number : 6160005

Lodz, Lódzkie, 92-213, Poland
Investigational Site Number : 6160006

Warsaw, Masovian Voivodeship, 02-097, Poland
Investigational Site Number : 6160007

Warsaw, Masovian Voivodeship, 04-746, Poland
Investigational Site Number : 6160008

Bialystok, Podlaskie Voivodeship, 15-274, Poland
Investigational Site Number : 6160009

Szczecin, West Pomeranian Voivodeship, 71-252, Poland
Investigational Site Number : 7050001

Ljubljana, 1000, Slovenia
Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7240002

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
Investigational Site Number : 7240003

Seville, Sevilla, 41009, Spain
Investigational Site Number : 7240004

Málaga, 29010, Spain
Investigational Site Number : 7240005

Oviedo, Principality of Asturias, 33011, Spain
Investigational Site Number : 7240006

Valencia, 46010, Spain
Investigational Site Number : 7240007

Vitoria-Gasteiz, Álava, 01009, Spain
Investigational Site Number : 7520001

Stockholm, 113 65, Sweden
Investigational Site Number : 7520002

Solna, 171 64, Sweden
Investigational Site Number : 7520003

Stockholm, 118 83, Sweden
Investigational Site Number : 8260001

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Investigational Site Number : 8260003

Birmingham, England, B15 2TH, United Kingdom
Investigational Site Number : 8260004

Leicester, Leicestershire, LE5 4PW, United Kingdom
Investigational Site Number : 8260006

Harrow, London, City of, HA1 3UJ, United Kingdom
Investigational Site Number : 8260007

Birmingham, England, B4 6NH, United Kingdom
Investigational Site Number : 8260009

Dundee, Dundee City, DD1 9SY, United Kingdom
Investigational Site Number : 8260010

Glasgow, Glasgow City, G51 4TF, United Kingdom
Joslin Diabetes Center - Boston- Site Number : 8400015

Boston, Massachusetts, 02215, United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007

Skokie, Illinois, 60077, United States
Ospedale Pediatrico Bambin Gesu IRCCS-Site Number : 3800007

Rome, Roma, 00165, Italy
Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009

Idaho Falls, Idaho, 83404, United States
The Children's Hospital of Philadelphia Site Number : 8400005

Philadelphia, Pennsylvania, 19104, United States
University at Buffalo - Downtown Campus- Site Number : 8400004

Buffalo, New York, 14203, United States
University of California San Francisco - Mission Bay- Site Number : 8400012

San Francisco, California, 94158, United States
University of Colorado - Anschutz Medical Campus- Site Number : 8400003

Aurora, Colorado, 80045, United States
University of Florida College of Medicine- Site Number : 8400010

Gainesville, Florida, 32610, United States
University of Miami Hospital- Site Number : 8400013

Miami, Florida, 33136, United States
University of North Carolina at Chapel Hill- Site Number : 8400001

Chapel Hill, North Carolina, 27514, United States
University of Texas - Southwestern Medical Center- Site Number : 8400011

Dallas, Texas, 75390, United States

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