Semaglutide in CFRD
This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with cystic fibrosis related diabetes (CFRD).
Conditions:
🦠 Cystic Fibrosis 🦠 Cystic Fibrosis-related Diabetes
🗓️ Study Start (Actual) 30 April 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 15
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adult subjects 18 years or older with CFRD and on insulin treatment
    • * BMI \>26 kg/m2
    • * Diagnosis of pancreatic insufficiency (based on treatment with pancreatic enzyme replacement therapy)
    • * A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Oral, injectable, or implanted hormonal contraceptives 3. Intrauterine device 4. Tubal ligation

    Exclusion Criteria:

    • * personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
    • * acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
    • * gastrointestinal(GI) symptom exacerbation defined by current nausea/vomiting or diarrhea at the baseline assessment
    • * history of chronic GI problems requiring hospitalization in the 1 year prior to baseline
    • * history of clinically symptomatic pancreatitis
    • * history of clinically significant gastroparesis
    • * history of eating disorders
    • * less than 24 weeks since start of a new CFTR corrector/modulator therapy
    • * pregnancy or lactation
    • * severe CF liver disease
    • * chronic kidney disease
    • * history of suicide attempts or active suicidal ideation
    • * Non-English speakers and those unable to read in English
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 March 2023
  • First Submitted that Met QC Criteria 15 March 2023
  • First Posted 29 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024