DFW Enterprises, Inc

Clinical Trials Identifier: NCT04786262

Trial name: A Safety, Tolerability, and Efficacy Study of VX-880 in Participants with Type 1 Diabetes Diabetes type: Adults 18-65 years of age with type 1 diabetes

Trial sponsor: Vertex Pharmaceuticals

This clinical trial is testing zimislecel (VX-880), the first fully differentiated cell-derived islet cell therapy for type 1 diabetes. Early study results so far are promising, with 12 participants no longer needing daily insulin after one year of therapy. Though immunosuppressants are required to prevent the body’s immune system from attacking and destroying the new cells (similar to when someone receives an organ transplant), research so far indicates that zimislecel could be the first functional cure for type 1 diabetes.

This clinical trial is unique in that it’s a combination phase 1, 2, and 3 trial. That means participants are being recruited to receive the therapy for the first time, as well as following people who have been in the study for years to see how zimislecel is working longer term.

You may be eligible to participate if you:

• Are 18-65 years old Have been diagnosed with type 1 diabetes for at least five years
• Have had at least two episodes of documented severe hypoglycemia in the past year
• Are on a stable diabetes treatment plan
• Have used a continuous glucose monitor (CGM) consistently for at least three months prior to screening for the trial, and are willing to use the CGM during the trial
• Have not had any prior islet cell transplants, organ transplants, or cell therapy

This trial is currently recruiting in 29 locations worldwide, including the U.S., Canada, France, Germany, the Netherlands, Norway, Switzerland, and more. Learn more about this study here or contact the Vertex study team at medicalinfo@vrtx.com or call (+)1-617-341-6777.