Verapamil Effect in Cystic Fibrosis-related Dysglycemia

Starting soon · Phase 2

Conditions studied: Cystic Fibrosis Related Diabetes, Cystic Fibrosis (CF), Abnormal Glucose Tolerance

In brief

The investigators are conducting a pilot open-label pre/post interventional trial in adolescents and adults with cystic fibrosis (CF) and abnormal glucose tolerance or early CF-related diabetes mellitus (CFRD) to assess the safety and efficacy of verapamil on beta cell function and dysglycemia.

Key facts

Study ID

NCT07688070

Run by

Rhode Island Hospital

People needed

30

Starts

2026-08-01

Expected to finish

2028-08-31

Last updated by the study team

2026-07-09

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 14 years and older
• Genetically-confirmed diagnosis of cystic fibrosis
• Clinical diagnosis of pancreatic insufficiency, defined as requiring pancreatic enzyme replacement therapy (PERT)
• Diagnosis of AGT or CFRD within 3-months of study enrollment
• AGT is defined as having either a OGTT 2-hour glucose >140 mg/dL and <200 mg/dL or OGTT 1-hour glucose >200 mg/dL
• CFRD is defined as having a fasting glucose >126 mg/dL and/or OGTT 2-hour glucose >200 mg/dL
• Willing to attempt to maximize verapamil to the goal study dosage of 360 mg PO daily
• If taking elexacaftor/tezacaftor/ivacaftor (ETI), willing to adjust dosing

You may not qualify if…

• Severe lung disease indicated by forced expiratory volume in 1 second (FEV1) <50% predicted on most recent spirometry testing
• Body mass index (BMI) <18 kg/m2
• Weight <50 kg
• Current or planned pregnancy within the next 6 months
• Treatment with IV antibiotics for a CF exacerbation within 1 month
• Systemic supraphysiologic glucocorticoid use within 1 month
• Initiation or discontinuation of a CFTR modulator within 3 months (i.e. recent change in CFTR modulator formulation/usage)
• Current use of insulin, a GLP-1 receptor agonist, or oral anti-diabetic agent
• Most recent HbA1c >7%
• Not taking a CFTR modulator due to genotype-ineligibility
• Current use of vanzacaftor/tezacaftor/deutivcaftor
• Known hypersensitivity to verapamil
• Blood pressure (BP) <90/60 (adults) or <5th centile for age and gender (youth) in 2 out of 3 measurements
• Heart rate (HR) <60 bpm (adults) or <2nd centile for age and gender (youth) in 2 out of 3 measurements
• History of previously diagnosed vasovagal syncopal episodes related to hypotension
• History of significant cardiac disease (e.g. severe ventricular dysfunction, hypertrophic cardiomyopathy)
• History of certain arrhythmias (e.g. AV block, accessory pathway such as Wolff-Parkinson-White or Lown-Ganong-Levine syndromes)
• Abnormal liver function tests defined as AST or ALT >1.5 upper limit of normal [ULN] at the time of screening, or end stage cirrhosis
• End stage renal disease on dialysis
• History of Duchenne's muscular dystrophy
• Need for the use of any pertinent medications (beta blockers, carbamazepine, phenobarbital, phenytoin, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine).
• Allergy to any of the components of the MMTT standardized meal

Where it is running

• Diabetes Research Center, Massachusetts General Hospital — Boston, Massachusetts, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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