Trial Outcomes & Findings for Effects of Semaglutide on Nicotine Intake (NCT NCT05530577)
NCT ID: NCT05530577
Last Updated: 2025-08-22
Results Overview
Number of cigarettes smoked during a laboratory smoking procedure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline (Week 0) to post-medication (Week 8)
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Semaglutide
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Semaglutide on Nicotine Intake
Baseline characteristics by cohort
| Measure |
Semaglutide
n=12 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=12 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
43.9 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to post-medication (Week 8)Population: Analysis population includes participants who completed a post-treatment laboratory smoking session (n=10 semaglutide group, n=11 placebo group). Two participants in the semaglutide group and one participant in the placebo group discontinued participation prior to the post-treatment smoking session.
Number of cigarettes smoked during a laboratory smoking procedure
Outcome measures
| Measure |
Semaglutide
n=10 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=11 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Nicotine Self-Administration
|
-0.8 Number of cigarettes
Standard Deviation 0.63
|
-0.5 Number of cigarettes
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to post-medication (Week 8)Population: Analysis population includes participants who completed a post-treatment laboratory smoking session (n=10 semaglutide group, n=11 placebo group). Two participants in the semaglutide group and one participant in the placebo group discontinued participation prior to the post-treatment smoking session.
Duration (minutes) of resistance to smoking reinstatement during a laboratory lapse task
Outcome measures
| Measure |
Semaglutide
n=10 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=11 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Nicotine Reinstatement Duration
|
10.3 Minutes
Standard Deviation 27.6
|
-2.2 Minutes
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to study endpoint (Week 10)Number of cigarettes consumed per day during medication exposure
Outcome measures
| Measure |
Semaglutide
n=10 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=10 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Daily Cigarette Smoking
|
-3.35 Number of cigarettes per day
Standard Deviation 5.25
|
-2.27 Number of cigarettes per day
Standard Deviation 4.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (Week 0) to post-medication (Week 8)Self-reported craving during a cue exposure task
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (Week 0) to post-medication (Week 8)Self-reported responses to cigarette smoking during a laboratory smoking procedure The Cigarette Purchase Task is a 21-question self-reported measure to understand motivation for obtaining cigarettes which asks participants about the number of cigarettes they would purchase and smoke based on an increasing cigarette cost.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (Week 0) to study endpoint (Week 10)Body weight
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (Week 0) to study endpoint (Week 10)Hemoglobin A1C (HbA1c)
Outcome measures
Outcome data not reported
Adverse Events
Semaglutide
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sham/Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Semaglutide
n=12 participants at risk
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=12 participants at risk
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
4/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
2/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
2/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
5/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
0.00%
0/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
41.7%
5/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
2/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Decreased Appetite
|
83.3%
10/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
25.0%
3/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Fatigue
|
33.3%
4/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
0.00%
0/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
0.00%
0/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Increased Appetite
|
0.00%
0/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
2/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Insomnia
|
8.3%
1/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
2/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Nervousness/Anxiety
|
16.7%
2/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
2/12 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
Additional Information
Christian Hendershot, PhD
University of Southern California
Phone: 323-442-1082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place