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GLP-1 Agonist Therapy for Cystic Fibrosis-Related Glucose Intolerance

This study is investigating whether a medication called dulaglutide (a GLP-1 agonist) can help improve how the body produces insulin in people with cystic fibrosis (CF) who also have pancreatic insufficiency and abnormal glucose tolerance. Researchers believe that dulaglutide, given weekly, might improve early insulin secretion and glucose tolerance. The study aims to enroll 30 adults, aged 18 or older, who have a confirmed CF diagnosis and require pancreatic enzyme replacement. The main goal is to see how dulaglutide affects early-phase insulin secretion after 18 weeks. The current status of this study is unclear.

Study design
This is a randomized, open-label, cross-over study involving 30 participants. Participants will either receive dulaglutide 0.75 mg weekly or be in an observation group for 6 weeks.
What's involved
Participants will be exposed to dulaglutide for 6 weeks or be in an observation group. The primary endpoint for measuring insulin secretion is at 18 weeks.
Compensation
Not stated in the trial record.
Follow-up
Early-phase insulin secretion will be measured at 18 weeks after the start of the study.

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NCT04731272

GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance

Recruiting
PHASE2Ages 18+Interventional
University of Pennsylvania
~30 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Dulaglutide 0.75Mg/0.5Ml Inj Pen

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Early-phase insulin secretion
Measured over 18 weeks

Conditions

Cystic Fibrosis
Pancreatic Insufficiency
Abnormal Glucose Tolerance
Diabetes

Explore related trials

Cystic FibrosisCystic Fibrosis Related Diabetes

Where it's being run

2 sites across 2 states
Colorado1
Pennsylvania1

Study leadership

  • Michael R Rickels, MD, MS · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Andrea Kelly, MD, MSCE · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Paola Alvarado, MS
[email protected]
215-746-2081
Email the study team

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Eligibility criteria

Inclusion

1\. Male or female, aged ≥18 years on date of consent
2\. Confirmed diagnosis of CF, defined by positive sweat test or Cystic Fibrosis transmembrane conductance regulator (CFTR) mutation analysis according to Cystic Fibrosis Foundation (CFF) diagnostic criteria.
3\. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.
4\. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD.
5\. Ability to take subcutaneous medication and be willing to adhere to the weekly administration regimen and complete study specific procedures (MMTT)
6\. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of dulaglutide or observation administration; oral contraceptives, intra-uterine devices, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable

Exclusion

1\. BMI \<19 kg/m2
2\. Presence of first-degree atrioventricular block or other evidence for cardiac conduction system or structural heart defects
3\. Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment
4\. Known allergic reactions to any GLP-1 agonist, and any history of severe hypersensitivity reactions (anaphylaxis or angioedema)
5\. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
6\. Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to study procedures
7\. Gastrointestinal symptom exacerbation defined by current nausea/vomiting or diarrhea
8\. Established diagnosis of non-CF diabetes (e.g. type 1 diabetes) or CFRD with fasting hyperglycemia (fasting glucose ≥126 mg/dL \[use of prandial insulin or repaglinide will be permitted\])
9\. History of clinically symptomatic pancreatitis within the last year
10\. Prior lung, liver or other solid organ transplant
11\. Severe CF liver disease, as defined by the presence of portal hypertension
12\. History of fundoplication-related dumping syndrome
13\. Hemoglobin \<10 g/dL, within 90 days of study procedures or at screening
14\. Abnormal renal function, within 90 days of study procedures or at screening; defined as creatinine \>2x upper limit of normal (ULN) or potassium \>5.5mEq/L on non-hemolyzed specimen
15\. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject

What this trial measures

  • Early-phase insulin secretion18 weeks

    The primary outcome measure is the insulin secretory rate during the first 30-min during a mixed meal tolerance test (ISR-AUC30).