DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT04731272

RecruitingPhase 2

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

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

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

2

Enrollment

30

estimated

Study population

Cystic Fibrosis, Diabetes (other / unspecified), Prediabetes / glucose intolerance

Key I/E criterion

•HbA1c ≤8%

Primary endpoint

•Early-phase insulin secretion

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04731272
Org study ID848357

Timeline

Milestones

Study first posted2021-01-29actual
Study start2021-07-16actual
Last update posted2026-05-18actual
Primary completion2027-06-30estimated
Study completion2028-06-30estimated

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Cystic FibrosisDiabetes (other / unspecified)Prediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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.

1. There will be no restriction on enrollment of individuals with CFRD but without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg/dL)

2. Individuals with CFRD and fasting hyperglycemia (defined as above or by the use of basal insulin therapy) must also have a HbA1c ≤8% and a random (non-fasting) C-peptide ≥1.2 ng/mL17; enrollment of this subgroup will be limited to n =10.

•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 criteria

•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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Early-phase insulin secretion

Time frame:18 weeks

descriptive

Secondary/protocol endpoint

Early-phase insulin secretion adjusted for glucose excursion

Time frame:18 weeks

ratio, improvement

Secondary/protocol endpoint

Glucose tolerance

Time frame:18 weeks

Postprandial glucose

descriptive, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.