Actively Recruiting
Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over Trial
Led by University of Pennsylvania · Updated on 2026-05-18
30
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with pancreatic insufficient cystic fibrosis (PI-CF) who have abnormal glucose tolerance or cystic fibrosis-related diabetes (CFRD). The study aims to evaluate whether weekly injections of dulaglutide, a long-acting GLP-1 agonist, can improve early-phase insulin secretion and glucose tolerance. Diabetes is a major concern in PI-CF, and preserving insulin-producing beta-cell function may delay or prevent CFRD development. Participants will receive either dulaglutide 0.75 mg by weekly subcutaneous injection for 6 weeks or no intervention during separate periods in a randomized, open-label, cross-over design. Mixed meal tolerance tests will be performed at the start and after each 6-week period to assess insulin secretion and glucose tolerance. This phase 2 study compares the effects of dulaglutide therapy with observation. During the study, participants will undergo mixed meal tolerance tests and other assessments related to insulin secretion and glucose control. Researchers will measure early-phase insulin secretion and glucose tolerance over 18 weeks. Participants must be able to take weekly injections and comply with study procedures, including contraception use for females of reproductive potential. Safety monitoring will include clinical evaluations and laboratory tests to ensure participant well-being throughout the study.
CONDITIONS
Brief Title
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 years or older at consent
- Confirmed diagnosis of cystic fibrosis by sweat test or CFTR mutation analysis
- Pancreatic insufficiency requiring pancreatic enzyme replacement
- Abnormal glucose tolerance or cystic fibrosis-related diabetes (CFRD) based on OGTT criteria
- Ability to take subcutaneous medication and comply with weekly administration and study procedures
- For females of reproductive potential: use of effective contraception for at least 1 month before screening and during study plus 6 weeks after treatment
You will not qualify if you...
- Body mass index (BMI) less than 19 kg/m2
- Cardiac conduction system or structural heart defects such as first-degree atrioventricular block
- Pregnancy or breastfeeding (confirmed by negative pregnancy test)
- Allergy or severe hypersensitivity to GLP-1 agonists
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
- Recent pulmonary exacerbation requiring IV antibiotics or systemic steroids within 4 weeks
- Current gastrointestinal symptoms like nausea, vomiting, or diarrhea
- Non-cystic fibrosis diabetes or CFRD with fasting hyperglycemia (fasting glucose ≥126 mg/dL) except use of prandial insulin or repaglinide
- History of pancreatitis within the last year
- Prior organ transplant including lung or liver
- Severe cystic fibrosis liver disease with portal hypertension
- History of dumping syndrome related to fundoplication surgery
- Hemoglobin less than 10 g/dL within 90 days before study
- Abnormal kidney function with creatinine over twice normal or potassium over 5.5 mEq/L within 90 days
- Any illness or condition that may affect study results or pose additional risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks per treatment period
Participants receive weekly subcutaneous injections of dulaglutide or no intervention during observation periods to assess effects on insulin secretion and glucose tolerance.
Weekly visits for up to 6 weeks per treatment period
Trial Site Locations
Total: 2 locations
1
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
P
Paola Alvarado, MS
C
Cornelia Dalton-Bakes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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