Thursday, November 16, 2023
Carmot Therapeutics Inc. (Carmot) has announced the initiation of a Phase 2 clinical trial for its CT-868, a once-daily dual GLP-1/GIP receptor agonist. The trial is designed to evaluate CT-868 as an adjunctive treatment for individuals with overweight or obesity and Type 1 Diabetes (T1D).
Results from a prior Phase 2 clinical trial of CT-868 showed a significant reduction in HbA1c at Week 26 in overweight or obese participants with Type 2 Diabetes (T2D). The 4.0 mg dose demonstrated a placebo-adjusted reduction of 2.31% from baseline, and the treatment was well-tolerated, with predominantly mild gastrointestinal-related adverse effects. These findings, coupled with earlier preclinical and clinical studies on the mechanism of action, provide a strong basis for investigating CT-868 as an adjunct to insulin for T1D.
In addition to the Phase 2 trial, Carmot is conducting an ongoing Phase 1b active comparator crossover clinical trial comparing the effects of CT-868 with liraglutide in T1D participants. CT-868 is one of three clinical-stage candidates in Carmot's pipeline addressing obesity and diabetes.
Carmot, expressed optimism about progress across all three clinical programs. The Phase 2 trial in adult participants with overweight or obesity and T1D will assess the impact of CT-868 versus placebo on the percent change in HbA1c and other continuous glucose monitoring (CGM)-related metrics over 16 weeks. Approximately 95 participants will be enrolled across clinical trial centers in the United States, with all participants continuing insulin therapy and wearing a CGM device throughout the trial.
Furthermore, Carmot's Phase 1b mechanism of action crossover clinical trial involving 24 T1D participants aims to evaluate the effects of CT-868, liraglutide, or placebo on glucose homeostasis using a mixed meal tolerance test.
CT-868, a once-daily subcutaneous injectable, is designed as a dual GLP-1/GIP receptor agonist to be administered as an adjunct to insulin for individuals with T1D and overweight or obesity. The Phase 2 trial is expected to generate valuable data in 2024, contributing to Carmot's ongoing efforts in advancing therapies for obesity and diabetes. Additional trial information can be found on clinicaltrials.gov using identifiers NCT06062069 and NCT05794581.