Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date
| Group | Value (Participants) |
|---|---|
| Smoking Cessation Counseling & Liraglutide | 2 |
| Smoking Cessation Counseling & Placebo | 2 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name DAL
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This clinical research trial examines the effects of the GLP-1 receptor agonist liraglutide on smoking behavior, food intake, and weight gain. In this double-blind, placebo-controlled, parallel arm pilot study, overweight and obese smokers (N=40; 20 female and 20 male) will be randomized to 32 weeks of liraglutide or placebo and undergo 8 sessions of smoking cessation behavioral counseling. Outcomes are smoking abstinence and weight change.
Experimental
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).
Active comparator
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).
Outcomes the sponsor listed as primary.
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date
Time frame · Week 18
Biochemically verified carbon monoxide (CO) reading \<5 using a Vitalograph Breath CO Analyzer
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date
Time frame · Week 32
Biochemically verified carbon monoxide (CO) reading \<5 using a Vitalograph Breath CO Analyzer
Body Weight at 12 Weeks Post-Target Quit Date
Time frame · Week 18
Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes
Body Weight at 26 Weeks Post-Target Quit Date
Time frame · Week 32
Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Smoking Cessation Counseling & Liraglutide | 2 |
| Smoking Cessation Counseling & Placebo | 2 |
| Group | Value (Participants) |
|---|---|
| Smoking Cessation Counseling & Liraglutide | 2 |
| Smoking Cessation Counseling & Placebo | 2 |
| Group | Value (lb) | Spread |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | 209.8 | 14.4 |
| Smoking Cessation Counseling & Placebo | 212.6 | 17.8 |
| Group | Value (lb) | Spread |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | 234.4 | 37.6 |
| Smoking Cessation Counseling & Placebo | 209.8 | 19.0 |
| Group | Value (kcal/day) | Spread |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | 1994.4 | 680.7 |
| Smoking Cessation Counseling & Placebo | 1703.9 | 484.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Smoking Cessation Counseling & LiraglutideParticipants 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. | 0 / 19 | 0 / 19 | 18 / 19 |
| Smoking Cessation Counseling & PlaceboParticipants 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. | 0 / 21 | 2 / 21 | 20 / 21 |
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