Semaglutide in CFRD

NCT05788965 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MED-2023-29616
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystic Fibrosis; Cystic Fibrosis-related Diabetes

Keywords

CFRD

Outcome Measures

Primary Outcomes (2)

• Weight

  Change in weight before and 12 weeks post treatment

  12 weeks

• BMI (kg/m2)

  Change in BMI before and 12 weeks post treatment

  12 weeks

Secondary Outcomes (2)

• CGM % Time in Target TIR)

  12 weeks

• A1c

  12 weeks

Study Arms (1)

Single Arm

OTHER

Semaglutide 1 mg once weekly subcutaneous injection

Drug: Semaglutide

Interventions

Semaglutide DRUG

glucagon-like peptide 1 (GLP-1) receptor agonist

Also known as: GLP-1 RA, Semaglutide Injectable Product

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Limitations and Caveats

there was no placebo control

Results Point of Contact

• Title: Amir Moheet
• Organization: University of Minnesota

mohee002@umn.edu

612-624-3209

Study Officials

• Amir Moheet, MBBS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: October 16, 2023
• Primary Completion: December 23, 2024
• Study Completion: December 31, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Locations

US (1)