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DAL
CompletedPhase 2Results postedDaily Liraglutide for Nicotine Dependence
Glucagon-like Peptide-1 Receptor Agonists as Novel Pharmacotherapies for Nicotine Dependence
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
40
actual
Study population
Alcohol / substance use, Obesity / overweight
Key I/E criterion
•BMI ≥27
Primary endpoint
•7-day Point Prevalence Smoking Abstinence
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
Eligible subjects will be males and females:
1. 18 years of age or older who self-report smoking cigarettes (menthol and non-menthol) at least 10 times per day, on average, for the past 6 months.
2. Interested in quitting smoking (defined as "intend to quit within one month").
3. Body mass index (BMI) greater than or equal to 27 kg/m2 with one weight-related comorbidity (e.g. high blood pressure, high cholesterol, dyslipidemia) or greater than or equal to 30 kg/m2 per the manufacturer label for weight management.
4. Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, intrauterine device (IUD), tubal ligation) or agree to abstain from sexual intercourse during the time they are in the study.
5. Able to communicate (speak, read, and write) fluently in English.
6. Capable of giving written informed consent before any study-related activities, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.
7. If current or past diagnosis of bipolar disorder, eligible if:
1. No psychotic features
2. MADRS: total score less than 8 (past 4 weeks); suicidal item score less than 1 (past 4 weeks)
3. Young Mania Rating Scale (Y-MRS): total score less than 8 (past 4 weeks); irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks)
4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
5. No aggressive or violent acts or behavior in the past 6 months
Exclusion criteria
Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.
Smoking Behavior:
1. Current enrollment in a smoking cessation program, or use of other smoking cessation medications (e.g. Chantix/varenicline, Zyban/bupropion, nicotine replacement therapy/gum/patch, etc.) in the last month or plans to do either in the next 2 months.
2. Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes.
Alcohol/Drug Use:
1. Self-report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months.
2. Current untreated and unstable diagnosis of severe substance use disorder (eligible if past use and/or if receiving treatment and stable for at least 30 days). Current untreated and unstable moderate substance use disorder requires Study Physician approval.
3. A positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, and/or ecstasy (MDMA).
1. Participants believed to have a false-positive result on the drug screen may continue with the study with investigator approval.
Medical:
1. Females who self-report current pregnancy, planning a pregnancy during the study, currently breastfeeding/lactating, or not using adequate contraceptive measures. All female participants will undergo a urine pregnancy test at Intake and at every in-person study visit.
2. Current diagnosis of unstable and untreated major depression, as determined by self-report \& MINI International Neuropsychiatric Interview (MINI) (eligible if stable for at least 30 days).
3. Current or past diagnosis of psychotic disorder, as determined by self-report or MINI. Mood Disorder with Psychotic Features determined by MINI requires PI approval for eligibility.
4. Suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS) indicated by active suicidal ideation (within past 30 days), any suicidal attempt within the past 2 years, or 2 or more lifetime suicidal attempts.
5. Self-reported kidney and/or liver disease or transplant.
6. Heart/Cardiovascular disease (e.g., angina, coronary heart disease, stroke, etc.) in the past 6 months.
7. Type-1 or type-2 diabetes (previously diagnosed or indicated by HbA1c level of 6.5% or higher).
8. Uncontrolled hypertension (BP systolic greater than 159 and/or diastolic greater than 99)*.
9. Personal or family history of medullary thyroid carcinoma (MTC).
10. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
11. History of pancreatitis.
12. History of gallbladder disease.
13. A blood glucose level less than 70 mg/dl at the Intake Visit.
14. Prior history, or plans, of surgical intervention for weight loss.
15. Hypersensitivity to liraglutide or any product components.
16. Current diagnosis of hyperthyroidism or hypothyroidism (requires thyroid function test review by study physician (SP) to determine eligibility)
17. Recent weight loss (more than or equal to 5% body weight) in the past 3 months
Medications:
1. Current or recent use (last 14 days) of weight loss medication, and/or use of medications known to impact weight (e.g. corticosteroids, excluding inhaled).
General Exclusion:
1. Current, anticipated, or pending enrollment in another research program over the next 2-3 months that could potentially affect subject safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.
2. Not planning to live in the area for the next 9 months.
3. Previous participation in this trial (i.e., previously randomized and started study medication).
4. Any impairment (physical and/or neurological) including visual or other impairment preventing ability to complete study tasks.
5. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
Endpoints (10)
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 endpointsBody Weight at 12 Weeks Post-Target Quit Date
Time frame:Week 18
descriptive
Posted result
| Group | Value (mean), lb | 95% CI |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | 209.8 | — |
| Smoking Cessation Counseling & Placebo | 212.6 | — |
Body Weight at 26 Weeks Post-Target Quit Date
Time frame:Week 32
descriptive
Posted result
| Group | Value (mean), lb | 95% CI |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | 234.4 | — |
| Smoking Cessation Counseling & Placebo | 209.8 | — |
Body Weight at 12 Weeks Post-Target Quit Date
Time frame:Week 18
descriptive
Body Weight at 26 Weeks Post-Target Quit Date
Time frame:Week 32
descriptive
Other clinical outcomes
6 endpointsNumber of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date
Time frame:Week 18
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | 2 | — |
| Smoking Cessation Counseling & Placebo | 2 | — |
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date
Time frame:Week 32
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | 2 | — |
| Smoking Cessation Counseling & Placebo | 2 | — |
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date
Time frame:Week 18
threshold achievement, improvement
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date
Time frame:Week 32
threshold achievement, improvement
Calories Consumed Per Day
Time frame:Weeks 0, 5, 18, & 32
descriptive
Calories Consumed Per Day
Time frame:Weeks 0, 5, 18, & 32
descriptive
Posted result
| Group | Value (mean), kcal/day | 95% CI |
|---|---|---|
| Smoking Cessation Counseling & LiraglutideWeek 0 | 1994.4 | — |
| Week 5 | 1572.2 | — |
| Week 18 | 1352.1 | — |
| Week 32 | 1360.3 | — |
| Smoking Cessation Counseling & PlaceboWeek 0 | 1703.9 | — |
| Week 5 | 1781.3 | — |
| Week 18 | 1582.6 | — |
| Week 32 | 1797.6 | — |
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.