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

Vertex Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Cystic Fibrosis

Treatments

Drug: ELX/TEZ/IVA

Drug: IVA

Study type

Interventional

Funder types

Industry

Identifiers

NCT04599465

VX19-445-117

2020-003170-44 (EudraCT Number)

Details and patient eligibility

About

This study was 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.

Enrollment

69 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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) defined as 2 hour post OGTT blood glucose level ≥140 to <200 mg/dL (≥7.77 to <11.10 mmol/L) and fasting blood glucose level <126 mg/dL (<7.00 mmol/L)
- CF-related diabetes (CFRD) defined as either fasting hyperglycemia (blood glucose level ≥126 mg/dL [≥7.00 mmol/L] after an 8-hour fast) or 2-hour post OGTT blood glucose level ≥200 mg/dL (≥11.10 mmol/L)

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.