Once-weekly insulin efsitora alfa: Design and rationale for the QWINT phase 3 clinical development programme

Area of Science:

• Endocrinology and Metabolism
• Clinical Pharmacology
• Diabetes Research

Background:

• Insulin efsitora alfa represents a new formulation of basal insulin administered once weekly.
• The QWINT (Once Weekly Insulin Therapy) program is a comprehensive Phase 3 clinical development initiative.

Purpose of the Study:

• To describe the study design and rationale for the efsitora phase 3 QWINT clinical development program.
• To outline the objectives and methodologies of the five QWINT trials (QWINT-1 to QWINT-5).

Main Methods:

• Five multicenter, randomized, controlled, open-label, treat-to-target trials.
• Inclusion of insulin-naïve adults with type 2 diabetes (T2D), T2D patients on basal insulin, and adults with type 1 diabetes.
• Comparison of efsitora efficacy and safety against once-daily basal insulin comparators (insulin glargine U100 or insulin degludec U100).

Main Results:

• Primary endpoint: change in HbA1c from baseline at 26 or 52 weeks.
• Secondary endpoints: changes in fasting glucose, insulin dose, continuous glucose monitoring (CGM) metrics, and patient-reported outcomes.
• Efficacy and safety data were collected across diverse patient populations.

Conclusions:

• The QWINT program enrolled a racially and geographically diverse population.
• Provides crucial data on the efficacy and safety of once-weekly insulin efsitora alfa.
• Informs the clinical management of diabetes with this novel basal insulin formulation.