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ONSET
RecruitingPhase 4Impact of Semaglutide on Tobacco Use and Related Health Behaviors
Impact of Semaglutide Administration on Tobacco Use Behavior and Related Mechanisms Among Smokers With Obesity
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
40
estimated
Study population
Alcohol / substance use, Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Alcohol consumption, 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Aged 18-65;
2. report daily use of >2 cigarettes per day (CPD), as this is a sufficient threshold for detecting tobacco use disorder, per MPI Oliver's published work57;
3. meet criteria for obesity (BMI ≥30 kg/m2); and
4. no immediate desire to quit tobacco use (using criteria form the clinical practice guidelines for treating tobacco dependence)
Exclusion criteria
1. Severe psychiatric disturbance precluding successful completion of the study, defined as
a. Ever schizophrenia, schizoaffective disorder, or bipolar disorder (assessed at the screener and again at baseline); b. Psychiatric hospitalization in the past year (assessed at the screener and again at baseline); c. Suicidal ideation in the past month or any past year suicide attempt (assessed at baseline)
v. Worsening symptoms of depression or anxiety in the past 3-months (as determined by Medical History Questionnaire).
2. personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, and personal history of pancreatitis, type I or type II diabetes, diabetic retinopathy, or gastroparesis;
3. current use of nicotine replacement therapy or other quit smoking medication;
4. history of bariatric surgery;
5. Current or past 6-month use of a GLP-1 agonist or any other weight-lowering/anti-obesity or glucose-lowering medications. These include (but are not limited to: sulfonylurea, insulin, metformin, thiazolidinediones (TZD), dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or GLP-1 analogs.
6. Clinical labs out of range/unacceptable:
1. creatinine ≥ 2 mg/dL, eGFR ≤ 60 mL/min/1.73 m2,
2. triglycerides> 500 mg/dl,
3. ALP > 4x the upper normal limit,
4. abnormal blood lipase levels,
5. other substantially abnormal clinical lab values as determined by the Study Practitioner
6. A1C 6.5% or higher
7. Glucose >126 mL fasting or >200mg/dL random
8. Alanine aminotransferase (ALT) >3x upper normal limit
7. History of significant gastrointestinal disorder, including inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if in remission), diverticular disease, severe gastroparesis, diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele, intestinal or colonic obstruction, or suspected intestinal obstruction, intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), pancreatitis, active biliary disease
8. Any other reason or clinical condition that the investigators judge would interfere with study participation and/or be unsafe for a possible subject.
9. Known or suspected allergy to semaglutide, any of the product components, or any other GLP-1 analogue.
Endpoints (2)
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
1 endpointWeight
Time frame:12 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Other clinical outcomes
1 endpointCigarette smoking
Time frame:12 weeks
Alcohol consumption, change
change from baseline, improvement
Provenance
Sources
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.