Phase 2 and Phase 3 · Semaglutide

NCT05788965 trial results

Efficacy and Safety of GLP-1 Agonist Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study

Participants
8
Status
completed
Completed
2024-12-31
Sponsor
University of Minnesota

As posted on ClinicalTrials.gov (NCT05788965), updated at source Jan 21, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT05788965 measured first

Weightkilograms · 12 weeks · mean
Semaglutide Treatmentn=8
-4.6(1.9)
BMI (kg/m2)kg/m2 · 12 weeks · mean
Semaglutide Treatmentn=8
-1.8(0.9)
Side effects by arm

Side effects in NCT05788965

Percent of participants affected, 12 weeks. The most common events the registry lists.

EventSemaglutide Treatment
Any serious event0%
Nausea62.5%
Heartburn37.5%
Constipation25%
Vomiting25%
Abdominal pain12.5%
Secondary outcomes

What else it measured

CGM % Time in Target TIR)percentage time in target · 12 weeks · mean
Semaglutide Treatmentn=8
7(10.5)
A1cchange in the percent of HbA1c · 12 weeks · mean
Semaglutide Treatmentn=8
-0.3(0.3)
The trial

How NCT05788965 was run

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).

  • Single Arm: Semaglutide 1 mg once weekly subcutaneous injection
Who could join the trial

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

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.