Semaglutide in CFRD

University of Minnesota (UMN)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cystic Fibrosis-related Diabetes

Cystic Fibrosis

Treatments

Drug: Semaglutide

Study type

Interventional

Funder types

Other

Identifiers

NCT05788965

MED-2023-29616

Details and patient eligibility

About

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).

Full 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

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
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