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ONSET

RecruitingPhase 4

Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Impact of Semaglutide Administration on Tobacco Use Behavior and Related Mechanisms Among Smokers With Obesity

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

NCT IDNCT06986993
Org study IDONSET

Timeline

Milestones

Study start2024-07-01actual
Study first posted2025-05-23actual
Last update posted2025-08-27actual
Primary completion2028-05-30estimated
Study completion2028-06-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance useObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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)

i.Suicidal ideation determined by the Ask Suicide Screening Questions (ASQ) Question 1-3
ii.Any suicide attempts in the past year (ASQ 4)
iii.Suicidal intent and plan (ASQ 5)
iv.PHQ-9 score of 20 or higher, indicating severe depression or PHQ-9 score of 15 or higher if participant also indicates worsening of symptoms in the past 3 months.

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
Other clinical outcomes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other clinical outcomes

1 endpoint
Primary/protocol endpoint/low confidence

Cigarette smoking

Time frame:12 weeks

Alcohol consumption, change

change from baseline, improvement

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.