Study of Oral AMX0035 to Assess Insulin Sensitivity and Mitochondrial Function in Adults with Type 1 Diabetes

What this Trial Is About

Researchers are studying the effects of a 24-week treatment with oral AMX0035, a combination of sodium phenylbutyrate and taurursodiol, compared to a placebo in adults with Type 1 Diabetes T1D. This randomized, double-blind, parallel-group clinical trial involves 60 participants and aims to evaluate changes in insulin sensitivity and mitochondrial function. The study is conducted at two medical centers and includes equal enrollment across sites. Participants will be randomly assigned to receive either AMX0035 or a placebo. The treatment starts with one packet daily for two weeks, followed by two packets daily morning and evening for approximately six months. The study includes metabolic assessments such as hyperinsulinemic-euglycemic clamp studies, body composition imaging, continuous glucose monitoring, and tissue biopsies for mitochondrial and biological marker analysis. All involved personnel are blinded to treatment assignments. Throughout the study, participants will undergo thorough evaluations at the beginning and end of the 24 weeks, including metabolic tests and safety monitoring. Researchers will measure insulin sensitivity, glycemic control, body composition, immune and metabolic biomarkers, and mitochondrial function. The study also assesses the safety and tolerability of AMX0035 during the treatment period. Participation involves following study procedures and attending scheduled assessments over the study duration.

METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)