Carmot Therapeutics has commenced a Phase 2 clinical trial of its once-daily dual GLP-1/GIP receptor agonist, CT-868, in adult participants with overweight or obesity with type 1 diabetes. The Phase 2 clinical trial in adult participants with overweight or obesity with T1D is designed to compare the effect of CT-868 versus placebo on the percent change in HbA1c from baseline to Week 16 of treatment, along with several other continuous glucose monitoring (CGM)-related metrics and other relevant endpoints.
Carmot anticipates enrolling approximately 95 participants at clinical trial centres across the US. All participants will continue to receive insulin therapy using either an insulin pump or multiple daily insulin injections, and all participants will wear a CGM device throughout the clinical trial. Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels, diet and exercise recommendations.
The company has previously presented results from another Phase 2 clinical trial of CT-868 that demonstrated a placebo-adjusted reduction in HbA1c in the 4.0 mg dose of 2.31% from baseline at Week 26 in overweight or obese participants with type 2 diabetes (T2D) and was well-tolerated, with the most common adverse effects being GI-related and mostly mild in severity. These data along with previous preclinical and clinical mechanism of action studies continue to provide both clinical and mechanistic rationale to pursue CT-868 as an adjunct to insulin for the treatment of T1D.
In addition to the Phase 2 clinical trial announced today, Carmot has an ongoing Phase 1b active comparator crossover clinical trial to assess the effects of CT-868 treatment on glucose homeostasis compared to liraglutide in participants with T1D. CT-868 is one of three clinical-stage product candidates in Carmot’s pipeline of therapeutics for the potential treatment of obesity and diabetes.
“This Phase 2 clinical trial represents an important next step in the CT-868 clinical program—with it, we look forward to evaluating the potential for CT-868 as an adjunctive treatment for people living with T1D,” said Dr Manu Chakravarthy, Carmot’s Chief Scientific & Medical Officer. “We remain very pleased with the progress across all three of our clinical programs and expect to have multiple data readouts from our obesity and diabetes pipeline throughout 2024.”
The Phase 1b mechanism of action crossover clinical trial in 24 T1D participants will assess the effect of CT-868, liraglutide or placebo on glucose homeostasis as assessed by a mixed meal tolerance test in a weight-independent manner.