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Semaglutide in CFRD

Primary Purpose

Cystic Fibrosis, Cystic Fibrosis-related Diabetes

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Semaglutide
Sponsored by
Amir Moheet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring CFRD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm 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.

Outcomes

Primary Outcome Measures

Feasibility, safety, tolerability
The primary outcomes are related to feasibility, including safety and treatment tolerability. Safety will be evaluated as the proportion (in %) of participants who experience a serious adverse event during the study. Tolerability will be evaluated as the proportion (in %) of participants who discontinue their assigned treatment due to side effects.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
June 22, 2023
Sponsor
Amir Moheet
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05788965
Brief Title
Semaglutide in CFRD
Official Title
Efficacy and Safety of GLP-1 Agonist Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amir Moheet
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Cystic Fibrosis-related Diabetes
Keywords
CFRD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
GLP-1 RA, Semaglutide Injectable Product
Intervention Description
glucagon-like peptide 1 (GLP-1) receptor agonist
Primary Outcome Measure Information:
Title
Feasibility, safety, tolerability
Description
The primary outcomes are related to feasibility, including safety and treatment tolerability. Safety will be evaluated as the proportion (in %) of participants who experience a serious adverse event during the study. Tolerability will be evaluated as the proportion (in %) of participants who discontinue their assigned treatment due to side effects.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Larson
Phone
612-625-2153
Email
cftrials@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Noren
Phone
612-625-7995
Email
cftrials@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Moheet, MBBS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Larson
Email
cftrials@umn.edu
First Name & Middle Initial & Last Name & Degree
Brooke Noren
Email
cftrials@umn.edu
First Name & Middle Initial & Last Name & Degree
Amir Moheet, MBBS
First Name & Middle Initial & Last Name & Degree
Joanne Billings, MD
First Name & Middle Initial & Last Name & Degree
Tasma Harindhanavudhi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.

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Semaglutide in CFRD

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