Cystic FibrosisPhase 2/3NCT05788965
Semaglutide in CFRD
A Phase 2/3 study testing Semaglutide in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 31 Dec 2024
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Efficacy and Safety of GLP-1 Agonist Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study
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).
Read the detailed description
The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial. In this study, we will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. We hypothesize that weekly administration of the long-acting GLP-1RA semaglutide to overweight/obese CFRD patients will be safe and well tolerated.
Specific Aim 1: Collect pilot data on the safety and feasibility of weekly semaglutide therapy in overweight and obese patients with CFRD to support a future larger randomized controlled trial.
Hypothesis 1: Weekly therapy with GLP-1RA semaglutide will be safe and well tolerated in overweight/obese adults with CFRD.
Specific Aim 2: Collect preliminary data to examine the impact of semaglutide therapy on insulin secretion, glucagon and glucose levels as measured by oral glucose tolerance test (OGTT), and on glycemic outcomes as measured by continuous glucose monitoring (CGM) and HbA1c.
Hypothesis 2a: Treatment with semaglutide will lower glucose levels, and increase insulin and C-peptide area under the curve (AUC) during the OGTT as compared to baseline.
Hypothesis 2b: Treatment with semaglutide will improve glycemic control as indicated by time in range on CGM and HbA1c
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- Being tested
- Semaglutide
- Keywords
- CFRD
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called GLP-1 RA, Semaglutide Injectable Product
glucagon-like peptide 1 (GLP-1) receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Semaglutide 1 mg once weekly subcutaneous injection Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Change in weight before and 12 weeks post treatment
Measured: 12 weeks
BMI (kg/m2)
Change in BMI before and 12 weeks post treatment
Measured: 12 weeks
Secondary outcomes (2)
CGM % Time in Target TIR)
Change in CGM TIR before and 12 weeks post treatment. Outcome reflects the change in continuous glucose monitoring (CGM) time in range (TIR), measured at baseline and again 12 weeks after treatment initiation.
TIR is defined as the percentage of time glucose values are between 70 and 180 mg/dL
Measured: 12 weeks
A1c
change in the percent of HbA1c before and 12 weeks post treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start16 Oct 2023
- Primary completion23 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 CFRD.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Amir Moheet, MBBS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788965
- Sponsor's protocol ID
- MED-2023-29616
- Status last verified
- Jan 2026
- First submitted
- 15 Mar 2023
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.