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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
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
Study 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 belowSelect...
I am being treated for pancreatic insufficiency with enzyme replacement.
Select...
I am 18 or older with cystic fibrosis-related diabetes and on insulin.
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.
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 • NCT0418984821%
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
2019
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
189 Previous Clinical Trials
37,195 Total Patients Enrolled
182 Trials studying Cystic Fibrosis
34,258 Patients Enrolled for Cystic Fibrosis
Amir Moheet, MBBSPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver disease due to cystic fibrosis.You have tried to hurt yourself on purpose in the past, or you are currently thinking about hurting yourself.I have had painful pancreatitis before.I have been hospitalized for chronic GI issues within the last year.I have a history of severe stomach emptying issues.I am being treated for pancreatic insufficiency with enzyme replacement.I am 18 or older with cystic fibrosis-related diabetes and on insulin.You weigh more than what is considered healthy for your height.I started a new CFTR therapy less than 6 months ago.I have chronic kidney disease.I or my family have a history of medullary thyroid cancer or MEN2.I haven't needed IV antibiotics or steroids for a lung issue in the last 4 weeks.You have a history of struggling with eating habits and body image.I am currently experiencing nausea, vomiting, or diarrhea.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there present opportunities to join this experiment?
"The clinical trial registry at clinicaltrials.gov reveals that this study is not recruiting at the present time; it was first advertised on April 30th 2023 and last updated March 15th of the same year. Nevertheless, there are 429 other trials actively seeking participants right now."
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