Semaglutide in CFRD

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amir Moheet
• Collaborator: Cystic Fibrosis Foundation

Criteria

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