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Semaglutide for Cystic Fibrosis-Related Diabetes

Phase 2 & 3
Recruiting
Led By Amir Moheet, MBBS
Research Sponsored by Amir Moheet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of pancreatic insufficiency (based on treatment with pancreatic enzyme replacement therapy)
Adult subjects 18 years or older with CFRD and on insulin treatment
Must not have
Severe CF liver disease
History of clinically symptomatic pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of anticipated participation for an individual participant's would be around 15 weeks.duration anticipated to complete all study procedures, including any long-term follow-up, and data analysis is 24 months.
Awards & highlights

Summary

This trial will test if a drug can be used to help overweight/obese adults with cystic fibrosis-related diabetes manage their insulin better.

Who is the study for?
Adults over 18 with cystic fibrosis-related diabetes (CFRD), overweight/obese (BMI >26 kg/m2), on insulin, and with pancreatic insufficiency can join. They must not be pregnant or breastfeeding, have certain thyroid cancers or endocrine syndromes, severe liver/kidney disease, recent acute lung issues, chronic GI problems requiring hospitalization within a year, history of pancreatitis or gastroparesis, started new CFTR therapy in the last 24 weeks, have suicidal tendencies or eating disorders.Check my eligibility
What is being tested?
The trial is testing Semaglutide as an additional treatment to insulin for adults with CFRD who are overweight. It's an open label study where all participants know they're receiving the medication to assess its safety and how well it's tolerated.See study design
What are the potential side effects?
Semaglutide may cause gastrointestinal symptoms like nausea/vomiting and diarrhea. There could also be risks of inflammation of the pancreas (pancreatitis) and changes in blood sugar levels which will need monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am being treated for pancreatic insufficiency with enzyme replacement.
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I am 18 or older with cystic fibrosis-related diabetes and on insulin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe liver disease due to cystic fibrosis.
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I have had painful pancreatitis before.
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I have been hospitalized for chronic GI issues within the last year.
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I have a history of severe stomach emptying issues.
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I have chronic kidney disease.
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I or my family have a history of medullary thyroid cancer or MEN2.
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I am currently experiencing nausea, vomiting, or diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of anticipated participation for an individual participant's would be around 15 weeks.duration anticipated to complete all study procedures, including any long-term follow-up, and data analysis is 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of anticipated participation for an individual participant's would be around 15 weeks.duration anticipated to complete all study procedures, including any long-term follow-up, and data analysis is 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility, safety, tolerability

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Amir MoheetLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
15 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
190 Previous Clinical Trials
37,314 Total Patients Enrolled
183 Trials studying Cystic Fibrosis
34,377 Patients Enrolled for Cystic Fibrosis
Amir Moheet, MBBSPrincipal InvestigatorUniversity of Minnesota

Media Library

Single Arm Clinical Trial Eligibility Overview. Trial Name: NCT05788965 — Phase 2 & 3
Cystic Fibrosis Research Study Groups: Single Arm
Cystic Fibrosis Clinical Trial 2023: Single Arm Highlights & Side Effects. Trial Name: NCT05788965 — Phase 2 & 3
Single Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05788965 — Phase 2 & 3
~8 spots leftby Dec 2025
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