Phase 3
N=8
Semaglutide in CFRD
Cystic Fibrosis · Cystic Fibrosis-related Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05788965 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Weight — -4.6 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
-4.6 | — |
| PRIMARY BMI (kg/m2) |
-1.8 | — |
| SECONDARY CGM % Time in Target TIR) |
7 | — |
| SECONDARY A1c |
-0.3 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05788965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.