Anti-Thymocyte Globulin and Verapamil Start A Phase-2 Clinical Trial

[joshua levy]

Researchers at the University of Florida are launching a new Phase 2 clinical trial to evaluate a combination therapy for individuals recently diagnosed with type 1 diabetes. This study, titled "Precision Administration of Anti-Thymocyte Globulin (ATG) With or Without Verapamil," aims to preserve the body's ability to produce its own insulin by combining two different types of medication. The first is anti-thymocyte globulin, which is a protein-based drug designed to modify the immune system by targeting T cells. The second is verapamil, a pill commonly used to treat high blood pressure. By using these two treatments together, investigators hope to stop the immune system's attack on the pancreas while simultaneously reducing the stress on the remaining insulin-producing cells.

As I’ve discussed in past blog posts, both treatments have shown early promise, but not success.  Here are two on ATG:

https://cureresearch4type1diabetes.blogspot.com/2023/05/low-dose-atg-preserves-beta-cell.html

https://cureresearch4type1diabetes.blogspot.com/2018/05/results-from-phase-ii-atg-and-gcsf.html

and here is one on Verapamil:

https://cureresearch4type1diabetes.blogspot.com/2022/11/verapamil-preserves-beta-cell-function.html

.

The Study

This is a phase 2 randomized controlled trial involving 60 participants aged 6 to 35 who have been diagnosed with type 1 diabetes within the last 100 days. Participants will be randomly assigned to receive either ATG or a placebo infusion. After one year, they will be re-randomized to receive either Verapamil or no additional treatment for a second year.

The primary goals of the study are to measure the difference in C-peptide levels (a marker of insulin production) between the ATG and placebo groups at 12 months, and to compare how these levels change over the first 6 months. Secondary goals include exploring the mechanisms behind how these treatments might work together to preserve beta cell function.

This research is supported by BreakthroughT1D (formerly known as JDRF).

For those interested in more information or participation, the global contact for the trial is:

Jennifer L. Hosford, MPH Phone: 352-294-5760 Email: jennifer...@peds.ufl.edu

The trial is currently recruiting participants at the following locations in the US:

• University of Florida, Gainesville, Florida
• Barbara Davis Center for Diabetes, Aurora, Colorado
• University of Miami, Miami, Florida (Collaborating Institution)

Discussion

Previous research in Anti-Thymocyte Globulin research has already shown a small effect to preserve C-peptide for a year or two. This is why the addition of Verapamil is interesting. In a mice study, the combination led to a reversal of T1D.   Both of these treatments have a solid safety record for people.

Verapamil has also shown promise in preserving beta cell function. A 2018 study by Ovalle and colleagues at the University of Alabama found that verapamil helped maintain C-peptide levels in adults with recently diagnosed type 1 diabetes.

More Information

The FDA Clinical Trials Registry: https://clinicaltrials.gov/study/NCT06455319

Cancelled Study: https://clinicaltrials.gov/study/NCT07061574

The University of Florida Diabetes Institute: https://diabetes.ufl.edu/

Wikipedia page for Anti-thymocyte globulin: https://en.wikipedia.org/wiki/Anti-thymocyte_globulin

Wikipedia page for Verapamil: https://en.wikipedia.org/wiki/Verapamil

DiaTribe article on Verapamil: https://diatribe.org/diabetes-medications/verapamil-and-type-1-diabetes

The 2018 Haller study in Diabetes Care: https://pubmed.ncbi.nlm.nih.gov/30012675/

The 2025 Degroote study in Diabetologia: https://doi.org/10.1007/s00125-025-06490-8

Joshua Levy

http://cureresearch4type1diabetes.blogspot.com 

publicjoshualevy at gmail dot com

All the views expressed here are those of Joshua Levy, and nothing here is official BreakthroughT1D or JDCA news, views, policies or opinions. I sometimes use generative AI ("chatbots") to generate draft blogs, parts of blogs, or drafter alternate wordings for these blogs. I always review every part of every published blog to ensure that it is saying what I want, in the tone that I want, truthfully, and accurately. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. I am obese and right on the border of T2D and therefore may be taking drugs for those conditions. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!