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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Semaglutide in CFRD

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
8 participants (actual)
Sponsor
University of Minnesota · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
16 Oct 2023
Primary completion
23 Dec 2024
Completion
31 Dec 2024
First posted
29 Mar 2023
Last update posted
21 Jan 2026
Conditions
Cystic Fibrosis · Cystic Fibrosis-related Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 2/3

    Semaglutide in CFRD

    NCT05788965

    16 Oct 2023 to 31 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • SemaglutideDrug

Arms1

  • Other

    Single Arm

    Semaglutide 1 mg once weekly subcutaneous injection

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Weight

    Time frame · 12 weeks

    Registry description

    Change in weight before and 12 weeks post treatment

  2. BMI (kg/m2)

    Time frame · 12 weeks

    Registry description

    Change in BMI before and 12 weeks post treatment

Secondary outcomes(2)
  1. CGM % Time in Target TIR)

    Time frame · 12 weeks

    Registry description

    Change in CGM TIR before and 12 weeks post treatment. Outcome reflects the change in continuous glucose monitoring (CGM) time in range (TIR), measured at baseline and again 12 weeks after treatment initiation. TIR is defined as the percentage of time glucose values are between 70 and 180 mg/dL

  2. A1c

    Time frame · 12 weeks

    Registry description

    change in the percent of HbA1c before and 12 weeks post treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 weeks

Weight

GroupValue (kilograms)Spread
Semaglutide Treatment-4.61.9
Primary outcomeMean· 12 weeks

BMI (kg/m2)

GroupValue (kg/m2)Spread
Semaglutide Treatment-1.80.9
Secondary and other outcome results(2)
Secondary outcomeMean· 12 weeks

CGM % Time in Target TIR)

GroupValue (percentage time in target)Spread
Semaglutide Treatment710.5
Secondary outcomeMean· 12 weeks

A1c

GroupValue (change in the percent of HbA1c)Spread
Semaglutide Treatment-0.30.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide TreatmentThis 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. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist0 / 80 / 87 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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