DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06924697

Enrolling by invitationPhase NA

Effect of Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Stimulation on Smoking Consumption in Type 2 Diabetes Patients

Effect of Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Stimulation on Smoking Consumption in Type 2 Diabetes Patients: Study Protocol of a Randomized, Parallel -Controlled Clinical Trial

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

46

estimated

Study population

Alcohol / substance use, Type 2 diabetes

Key I/E criterion

•Male

Primary endpoint

•AUDIT score

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 IDNCT06924697
Org study IDEC.D(BG).025.04.0

Timeline

Milestones

Study first posted2025-04-11actual
Last update posted2025-05-31actual
Study start2025-06-21estimated
Primary completion2026-01-11estimated
Study completion2026-07-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutide

Study populations

Who this study enrolls

Alcohol / substance useType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

1. Male patients aged 18-75 years.

2. Diagnosis of type 2 diabetes mellitus (T2DM) based on the World Health Organization (WHO) criteria.

3. A history of smoking for at least one year.

4. Fagerström Test for Nicotine Dependence (FTND) score ≥4.

5. Eligible for treatment with glucagon-like peptide-1 receptor agonists (GLP1-RAs) or dipeptidyl peptidase-IV (DPP-IV) inhibitors but have not previously used these medications.

6. Patients who fully understand the study, voluntarily participate, and sign the informed consent form.

Exclusion criteria

1. Diagnosis of type 1 diabetes or other specific types of diabetes.

2. Presence of diabetic ketoacidosis or severe diabetic complications.

3. Patients with severe cardiovascular, hepatic, renal, neurological, immune, or hematological diseases.

4. Presence of severe infections, malignancies, recent surgeries, or major trauma.

5. A history of severe recurrent hypoglycemia.

6. Severe gastrointestinal disorders, such as gastroparesis.

7. Poor adherence or inability to attend scheduled follow-up visits.

8. A history of pancreatitis or a high risk of developing pancreatitis.

9. Presence of severe psychiatric disorders, including schizophrenia, paranoid psychosis, bipolar disorder, or intellectual disability.

10. Contraindications to magnetic resonance imaging (MRI), such as metallic implants, pacemakers, or claustrophobia.

Endpoints (6)

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

Other clinical outcomes
3
Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

BMI

Time frame:From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24

BMI, change

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Laboratory testing

Time frame:From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24

descriptive

Secondary/protocol endpoint

Adverse reactions

Time frame:From enrollment to the end of treatment at 24 weeks.At weeks 0, 4, 12, and 24

Treatment-emergent AEs (any)

descriptive

Other clinical outcomes

3 endpoints
Primary/protocol endpoint/low confidence

Fagerstrom Test of Nicotine Dependence (FTND) scores

Time frame:From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Functional MRI changes

Time frame:From enrollment to the end of treatment at 24 weeks.At weeks 0 and 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Exhaled Carbon Monoxide (CO) Test

Time frame:From enrollment to the end of treatment at 24 weeks.At weeks 0, 12, and 24

descriptive

Publications (32)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.