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Semaglutide in CFRD

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ClinicalTrials.gov Identifier: NCT05788965
Recruitment Status : Recruiting
First Posted : March 29, 2023
Last Update Posted : June 26, 2023
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Amir Moheet, University of Minnesota

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Cystic Fibrosis-related Diabetes Drug: Semaglutide Phase 2 Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of GLP-1 Agonist Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study
Actual Study Start Date : April 30, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Single Arm
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.
 Drug: Semaglutide
glucagon-like peptide 1 (GLP-1) receptor agonist
Other Names:
  • GLP-1 RA
  • Semaglutide Injectable Product


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility, safety, tolerability [ 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05788965


Contacts
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Contact: Cathy Larson 612-625-2153 cftrials@umn.edu
Contact: Brooke Noren 612-625-7995 cftrials@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Cathy Larson       cftrials@umn.edu   
Contact: Brooke Noren       cftrials@umn.edu   
Principal Investigator: Amir Moheet, MBBS         
Sub-Investigator: Joanne Billings, MD         
Sub-Investigator: Tasma Harindhanavudhi, MD         
Sponsors and Collaborators
Amir Moheet
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Amir Moheet, MBBS University of Minnesota
More Information
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Responsible Party: Amir Moheet, Sponsor-Investigator, University of Minnesota
ClinicalTrials.gov Identifier: NCT05788965    
Other Study ID Numbers: Semaglutide in CFRD
First Posted: March 29, 2023    Key Record Dates
Last Update Posted: June 26, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amir Moheet, University of Minnesota:
CFRD
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Infant, Newborn, Diseases
Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs