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Semaglutide for Cystic Fibrosis-Related Diabetes

Phase 2 & 3

Recruiting

Led By Amir Moheet, MBBS

Research Sponsored by University of Minnesota

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility, safety, tolerability

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met