← Trials/Trial dossier/NCT05788965

CompletedPhase 2, PHASE3Results posted

Semaglutide in CFRD

Efficacy and Safety of GLP-1 Agonist Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

8

actual

Study population

Cystic Fibrosis, Diabetes (other / unspecified), Obesity / overweight

Key I/E criterion

BMI ≥26

Primary endpoints

Body weight, absolute change (kg)BMI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05788965
Org study IDMED-2023-29616

Timeline

Milestones

Study first posted2023-03-29actual
Study start2023-10-16actual
Primary completion2024-12-23actual
Study completion2024-12-31actual
Last update posted2026-01-21actual
Results first posted2026-01-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Cystic FibrosisDiabetes (other / unspecified)Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
4
Glycemic / diabetes
4

Weight & body composition

4 endpoints
Primary/registry result

Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kilograms95% CI
Semaglutide Treatment-4.6
Primary/registry result

BMI (kg/m2)

Time frame:12 weeks

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kg/m295% CI
Semaglutide Treatment-1.8
Primary/protocol endpoint

Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Primary/protocol endpoint

BMI (kg/m2)

Time frame:12 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/registry result

CGM % Time in Target TIR)

Time frame:12 weeks

CGM time-in-range

change from baseline, improvement

Posted result

GroupValue (mean), percentage time in target95% CI
Semaglutide Treatment7
Secondary/registry result

A1c

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), change in the percent of HbA1c95% CI
Semaglutide Treatment-0.3
Secondary/protocol endpoint

CGM % Time in Target TIR)

Time frame:12 weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

A1c

Time frame:12 weeks

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.