← Trials/Trial dossier/NCT03712098

DAL

CompletedPhase 2Results posted

Daily Liraglutide for Nicotine Dependence

Glucagon-like Peptide-1 Receptor Agonists as Novel Pharmacotherapies for Nicotine Dependence

Lead sponsor

Rebecca Ashare

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

NCT IDNCT03712098
Org study ID831835

Timeline

Milestones

Study first posted2018-10-19actual
Study start2018-11-29actual
Primary completion2022-05-25actual
Study completion2022-05-25actual
Last update posted2023-09-21actual
Results first posted2023-09-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance useObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Participants presenting with systolic blood pressure (SBP) greater than 159 mmHg and/or diastolic blood pressure (DBP) greater than 99 mmHg at the Intake visit will be instructed to sit quietly for 10 minutes. Then the participant will have a second blood pressure reading taken after a 10 minute period. If, after the second reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be instructed to sit comfortably for 10 minutes and then have a third blood pressure reading. If, after the third reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be ineligible to participate.

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

Other clinical outcomes
6
Weight & body composition
4

Weight & body composition

4 endpoints
Secondary/registry result

Body Weight at 12 Weeks Post-Target Quit Date

Time frame:Week 18

descriptive

Posted result

GroupValue (mean), lb95% CI
Smoking Cessation Counseling & Liraglutide209.8
Smoking Cessation Counseling & Placebo212.6
Secondary/registry result

Body Weight at 26 Weeks Post-Target Quit Date

Time frame:Week 32

descriptive

Posted result

GroupValue (mean), lb95% CI
Smoking Cessation Counseling & Liraglutide234.4
Smoking Cessation Counseling & Placebo209.8
Secondary/protocol endpoint

Body Weight at 12 Weeks Post-Target Quit Date

Time frame:Week 18

descriptive

Secondary/protocol endpoint

Body Weight at 26 Weeks Post-Target Quit Date

Time frame:Week 32

descriptive

Other clinical outcomes

6 endpoints
Primary/registry result

Number 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

GroupValue (count_of_participants), Participants95% CI
Smoking Cessation Counseling & Liraglutide2
Smoking Cessation Counseling & Placebo2
Primary/registry result

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

GroupValue (count_of_participants), Participants95% CI
Smoking Cessation Counseling & Liraglutide2
Smoking Cessation Counseling & Placebo2
Primary/protocol endpoint

Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date

Time frame:Week 18

threshold achievement, improvement

Primary/protocol endpoint

Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date

Time frame:Week 32

threshold achievement, improvement

Other/protocol endpoint

Calories Consumed Per Day

Time frame:Weeks 0, 5, 18, & 32

descriptive

Other_pre_specified/registry result

Calories Consumed Per Day

Time frame:Weeks 0, 5, 18, & 32

descriptive

Posted result

GroupValue (mean), kcal/day95% CI
Smoking Cessation Counseling & LiraglutideWeek 01994.4
Week 51572.2
Week 181352.1
Week 321360.3
Smoking Cessation Counseling & PlaceboWeek 01703.9
Week 51781.3
Week 181582.6
Week 321797.6

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.