Research Background

Patients with cystic fibrosis commonly develop prediabetes due to pancreatic insufficiency. While loss of β‑cells is recognized as a primary driver of reduced insulin secretion, additional variable factors also contribute to disease progression. Consequently, therapies that preserve β‑cell function are needed.

Study Design

This is a Phase 2, randomized, placebo‑controlled, multi‑center trial currently enrolling, initiated in July 2021. Participants receive once‑weekly administration of the long‑acting glucagon‑like peptide‑1 (GLP‑1) receptor agonist dulaglutide to evaluate early improvements in insulin secretion. The primary endpoint is the measurement of glucose and insulin responses during a mixed‑meal tolerance test.

Mechanism and Expected Benefits

Dulaglutide mimics the action of endogenous gut hormones, enhancing glucose‑dependent insulin secretion and delaying gastric emptying. As a once‑weekly long‑acting formulation, it may improve patient adherence. Anticipated benefits include reduced β‑cell workload and enhanced glycemic control, potentially slowing the progression of cystic fibrosis‑related diabetes.

Market and Clinical Significance

Currently, treatment of cystic fibrosis‑related diabetes relies primarily on insulin supplementation, with few strategies targeting fundamental β‑cell protection. Success with dulaglutide would represent a differentiated mechanism from existing insulin therapy and could become a candidate for a new standard of care. If effective, its application could extend beyond cystic fibrosis patients to other disorders characterized by β‑cell atrophy.