A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Elexacaftor; Ivacaftor

Criteria

Key Inclusion Criteria:

• Heterozygous for F508del and an MF mutation (F/MF genotypes)

• Forced expiratory volume in 1 second (FEV1) value ≥ 30% of predicted mean for age, sex, and height

• Abnormal glucose tolerance determined by an OGTT as either:

• Impaired glucose tolerance (IGT)

• CF-related diabetes (CFRD)

Key Exclusion Criteria:

• Clinically significant liver cirrhosis with or without portal hypertension

• Solid organ or hematological transplantation

• Lung infection with organisms associated with a more rapid decline in pulmonary status

• Type 1 or Type 2 diabetes

• Duration of CFRD ≥5 years

Other protocol defined Inclusion/Exclusion criteria may apply