GLOBAL RESEARCH ARCHIVE
1Q26: CATT1 Enrollment Momentum Building; Ph3 Data Anticipated 1H27
Research evidence excerpt
1Q26: CATT1 Enrollment Momentum Building; Ph3 Data Anticipated 1H27
■ CATT1's use of CGM represents a meaningful methodological improvement over SimpliciT1 and should enhance data quality
and statistical power. A key differentiator of the CATT1 design relative to the SimpliciT1 Phase 2 program is the universal use
of continuous glucose monitoring (CGM) throughout the entire trial. In SimpliciT1, symptomatic hypoglycemia was collected
as a patient-reported adverse event, a methodology that inherently suffers from recall bias, with asymptomatic events being
particularly likely to go unreported. In CATT1, CGM captures glucose readings in real time, including asymptomatic and
nocturnal Level 2 hypoglycemic events that patients would never self-report. The net effect is that CGM should capture more
events per patient, improve completeness of data, and reduce recall bias. CGM also supports patient retention by eliminating
the need for fingerstick blood measurements required in other trials. As a result, CATT1 should benefit from greater statistical
power and higher data quality relative to its predecessor study. Patients must have used a CGM device for at least threeBIOTECHNOLOGY consecutive months prior to screening and may use continuous subcutaneous insulin infusion (CSII/insulin pump) or multiple
daily injections (MDI) for at least six months prior to treatment, remaining on their method of insulin administration for the
entirety of the study. Insulin pumps are set to manual mode for the duration of the study.
■ vTv continued to advance the broader cadisegliatin development program, including progress on supportive trials expectedEQUITY to initiate in 2026. vTv Therapeutics continued working on the design and execution of supportive trials for cadisegliatin,
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