Trial Outcomes & Findings for Daily Liraglutide for Nicotine Dependence (NCT NCT03712098)
NCT ID: NCT03712098
Last Updated: 2023-09-21
Results Overview
Biochemically verified carbon monoxide (CO) reading \<5 using a Vitalograph Breath CO Analyzer
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Week 18
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
Smoking Cessation Counseling & Liraglutide
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
| Measure |
Smoking Cessation Counseling & Liraglutide
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Daily Liraglutide for Nicotine Dependence
Baseline characteristics by cohort
| Measure |
Smoking Cessation Counseling & Liraglutide
n=19 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=21 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 6.2 • n=99 Participants
|
56.4 years
STANDARD_DEVIATION 5.6 • n=107 Participants
|
57.2 years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
21 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Body Mass Index
|
36.9 kg/m2
STANDARD_DEVIATION 1.8 • n=99 Participants
|
35.8 kg/m2
STANDARD_DEVIATION 1.4 • n=107 Participants
|
36.3 kg/m2
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Cigarettes smoked per day
|
16.6 cigarettes
STANDARD_DEVIATION 2.1 • n=99 Participants
|
16.7 cigarettes
STANDARD_DEVIATION 1.8 • n=107 Participants
|
16.7 cigarettes
STANDARD_DEVIATION 1.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 18Biochemically verified carbon monoxide (CO) reading \<5 using a Vitalograph Breath CO Analyzer
Outcome measures
| Measure |
Smoking Cessation Counseling & Liraglutide
n=19 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=21 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 32Biochemically verified carbon monoxide (CO) reading \<5 using a Vitalograph Breath CO Analyzer
Outcome measures
| Measure |
Smoking Cessation Counseling & Liraglutide
n=19 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=21 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 18Population: The number analyzed reflects rates due to attrition as only those who completed visits could provide measurement.
Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes
Outcome measures
| Measure |
Smoking Cessation Counseling & Liraglutide
n=3 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=8 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Body Weight at 12 Weeks Post-Target Quit Date
|
209.8 lb
Standard Deviation 14.4
|
212.6 lb
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: Week 32Population: The number analyzed reflects rates due to attrition as only those who completed visits could provide measurement.
Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes
Outcome measures
| Measure |
Smoking Cessation Counseling & Liraglutide
n=2 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=7 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Body Weight at 26 Weeks Post-Target Quit Date
|
234.4 lb
Standard Deviation 37.6
|
209.8 lb
Standard Deviation 19.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 0, 5, 18, & 32Population: The number analyzed differs due to attrition. Only those who completed each visit were analyzed.
The research team staff will use a multi-pass method with an interactive computerized software program, the Automated Self-Administered 24-hour Recall (ASA24®) tool to determine total kcal/day with participants over the phone.
Outcome measures
| Measure |
Smoking Cessation Counseling & Liraglutide
n=19 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=21 Participants
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Calories Consumed Per Day
Week 0
|
1994.4 kcal/day
Standard Deviation 680.7
|
1703.9 kcal/day
Standard Deviation 484.7
|
|
Calories Consumed Per Day
Week 5
|
1572.2 kcal/day
Standard Deviation 563.7
|
1781.3 kcal/day
Standard Deviation 662.9
|
|
Calories Consumed Per Day
Week 18
|
1352.1 kcal/day
Standard Deviation 485.2
|
1582.6 kcal/day
Standard Deviation 494
|
|
Calories Consumed Per Day
Week 32
|
1360.3 kcal/day
Standard Deviation 405.0
|
1797.6 kcal/day
Standard Deviation 518.5
|
Adverse Events
Smoking Cessation Counseling & Liraglutide
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Smoking Cessation Counseling & Placebo
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Smoking Cessation Counseling & Liraglutide
n=19 participants at risk
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=21 participants at risk
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
General disorders
Pain
|
0.00%
0/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
4.8%
1/21 • Number of events 1 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Cardiac disorders
TIA
|
0.00%
0/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
4.8%
1/21 • Number of events 1 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
Other adverse events
| Measure |
Smoking Cessation Counseling & Liraglutide
n=19 participants at risk
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Liraglutide: Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
Smoking Cessation Counseling & Placebo
n=21 participants at risk
Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).
Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation Counseling: All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
|
|---|---|---|
|
Gastrointestinal disorders
Indigestion
|
26.3%
5/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
9.5%
2/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Acid Reflux
|
26.3%
5/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
19.0%
4/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.1%
4/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
19.0%
4/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Psychiatric disorders
Anxiety
|
21.1%
4/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
38.1%
8/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Belching
|
21.1%
4/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
9.5%
2/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Bloating
|
5.3%
1/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
19.0%
4/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Skin and subcutaneous tissue disorders
Bruising at injection site
|
21.1%
4/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
19.0%
4/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Constipation
|
52.6%
10/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
19.0%
4/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Decreased Appetite
|
78.9%
15/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
61.9%
13/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Diarrhea
|
31.6%
6/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
14.3%
3/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
General disorders
Dizziness
|
31.6%
6/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
28.6%
6/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
General disorders
Dry Mouth
|
26.3%
5/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
47.6%
10/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
General disorders
Fatigue
|
57.9%
11/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
42.9%
9/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Flatulence
|
26.3%
5/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
23.8%
5/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
General disorders
Headache
|
47.4%
9/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
57.1%
12/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Cardiac disorders
Hypertension
|
36.8%
7/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
57.1%
12/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
General disorders
Insomnia
|
36.8%
7/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
47.6%
10/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Nausea
|
63.2%
12/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
38.1%
8/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
6/19 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
9.5%
2/21 • 8 months
The definitions do not differ. Adverse event reporting was completed using a symptom checklist, listing all expected side effects for the study drug, which was administered at all study visits and included severity rating and description of the symptom. Participants were also given the opportunity to report any events that were not listed on the checklist, provide a severity rating and description.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place