NCT05788965CompletedPhase 2/3
Semaglutide in CFRD
Efficacy and Safety of GLP-1 Agonist Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 15 Mar 2023
- Start date
- 16 Oct 2023
- Primary completion date
- 23 Dec 2024
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity, Cystic fibrosis
- NCT number
- NCT05788965
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 8
- From 16 Oct 2023 to the primary completion date, 23 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
- history of chronic GI problems requiring hospitalization in the 1 year prior to baseline
- less than 24 weeks since start of a new CFTR corrector/modulator therapy
Other illness
- personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
- history of clinically symptomatic pancreatitis
- history of clinically significant gastroparesis
- history of eating disorders
- severe CF liver disease
- chronic kidney disease
- history of suicide attempts or active suicidal ideation
Other
- gastrointestinal(GI) symptom exacerbation defined by current nausea/vomiting or diarrhea at the baseline assessment
- pregnancy or lactation
- Non-English speakers and those unable to read in English
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.