Phase 2 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older at the time of giving consent, of any gender.
• People with a confirmed diagnosis of cystic fibrosis (CF), based on a sweat test or genetic testing that meets recognised CF diagnostic standards.
• People whose CF has caused their pancreas to stop working properly, meaning they need to take digestive enzyme supplements with meals.
• People who have abnormal blood sugar levels based on a specific glucose tolerance test, or who have already been diagnosed with CF-related diabetes (CFRD).
• People with CFRD who do not have high fasting blood sugar levels may be enrolled without restriction.
• People with CFRD who do have high fasting blood sugar levels (fasting glucose of 126 mg/dL or above, or who use long-acting insulin) may also be considered, but only if their HbA1c (a measure of average blood sugar over time) is 8% or below and their C-peptide level (a marker of insulin production) is 1.2 ng/mL or above — enrollment of this smaller group is limited to 10 people (confirm with trial site).
• People who are able and willing to receive injections under the skin once a week and follow the study schedule, including a specific meal-based test.
• Women who could become pregnant must have been using a highly effective form of contraception for at least one month before screening, and must agree to continue using it throughout the study and for six weeks after the study ends — accepted methods include the pill, IUDs, hormonal implants, injectable contraceptives, or barrier methods used with spermicide; condoms alone are not accepted.

Who may not be able to join:

• People with a BMI below 19 kg/m².
• People with certain heart rhythm or structural heart problems, including a specific type of heart conduction delay (confirm with trial site).
• People who are pregnant or breastfeeding — a negative pregnancy test will be required at enrolment.
• People with a known allergy to a class of diabetes medications called GLP-1 agonists, or anyone with a history of severe allergic reactions such as anaphylaxis or severe swelling.
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid cancer) or a related inherited condition called Multiple Endocrine Neoplasia type 2 (MEN2).
• People who have had a lung infection flare-up requiring intravenous antibiotics or steroid treatment within the four weeks before the study begins.
• People currently experiencing nausea, vomiting, or diarrhoea.
• People diagnosed with a form of diabetes unrelated to CF (such as type 1 diabetes), or people with CFRD who have high fasting blood sugar (fasting glucose of 126 mg/dL or above) — note that use of mealtime insulin or repaglinide is permitted (confirm with trial site).
• People who have had a clinically significant episode of pancreatitis (inflammation of the pancreas) within the past year.
• People who have previously had a lung, liver, or other solid organ transplant.
• People with severe CF-related liver disease, specifically where there is increased pressure in the blood vessels around the liver (portal hypertension).
• People with a history of a condition called dumping syndrome related to a previous stomach surgery called fundoplication.
• People with a haemoglobin (red blood cell) level below 10 g/dL, measured within 90 days of the study or at screening.
• People with significantly reduced kidney function, measured within 90 days of the study or at screening — defined by specific blood test thresholds for creatinine or potassium (confirm with trial site).
• People with any other illness or condition that the study doctor believes could affect the results or create additional health risks.

Important: Always verify eligibility with the trial site directly before applying.