Trial Outcomes & Findings for Semaglutide for Alcohol Use Disorder (NCT NCT05520775)
NCT ID: NCT05520775
Last Updated: 2025-04-02
Results Overview
Estimated grams of ethanol consumed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline (Week 0) to post-medication (Week 8)
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
Semaglutide
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) 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
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Semaglutide for Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Semaglutide
n=24 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=24 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
Total
n=48 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
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
39.0 Years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
39.9 Years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 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
|
2 Participants
n=107 Participants
|
2 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
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 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
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to post-medication (Week 8)Population: Participants who completed pre- and post-treatment laboratory self-administration.
Estimated grams of ethanol consumed.
Outcome measures
| Measure |
Semaglutide
n=13 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) 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
|
|---|---|---|
|
Change in Alcohol Consumed
|
-32.72 grams
Standard Deviation 27.98
|
-6.95 grams
Standard Deviation 24.49
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to post-medication (Week 8)Population: Participants who completed pre- and post-treatment laboratory self-administration.
Peak breath alcohol concentration following an alcohol self-administration procedure.
Outcome measures
| Measure |
Semaglutide
n=13 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) 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
|
|---|---|---|
|
Change in Breath Alcohol Concentration
|
-0.034 g/dl
Standard Deviation 0.045
|
-0.016 g/dl
Standard Deviation 0.047
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to post-treatment (Week 8)Population: Participants with pre- and post-treatment data from an alcohol challenge laboratory session.
Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported feelings of stimulation during an alcohol challenge procedure. Possible responses are 0-10, 0 being "not at all" and 10 being "extremely". Scale score ranges from 0 to 70. Higher scores indicate greater stimulation effects.
Outcome measures
| Measure |
Semaglutide
n=22 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=18 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)
|
.45 Score on a scale
Standard Deviation 12.82
|
-1.28 Score on a scale
Standard Deviation 13.49
|
SECONDARY outcome
Timeframe: baseline (Week 0) to post-medication (Week 8)Population: Participants with pre- and post-treatment data from an alcohol challenge laboratory session.
Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported sedative effects during an alcohol challenge procedure. Possible responses are 0 "not at all" through 10 "extremely". Scale scores range from 0 to 70. Higher scores indicate greater sedative effects.
Outcome measures
| Measure |
Semaglutide
n=22 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=18 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Subjective Sedation (Biphasic Alcohol Effects Scale)
|
0.14 Score on a scale
Standard Deviation 10.69
|
-3.22 Score on a scale
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to post-treatment (Week 8)Population: Participants with pre- and post-treatment alcohol demand data.
The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero.
Outcome measures
| Measure |
Semaglutide
n=23 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=20 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Alcohol Demand (Alcohol Purchase Task)
|
-2.91 number of drinks
Standard Deviation 3.73
|
-2.90 number of drinks
Standard Deviation 7.82
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Post-medication (Week 8)Population: Participants who reported cigarette use at baseline and provided pre- and post-treatment cigarette demand data.
Self-report cigarette demand as measured by the Cigarette Purchase Task. Intensity scores reflect the number of cigarettes that would be purchased when cost is zero.
Outcome measures
| Measure |
Semaglutide
n=5 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=4 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Cigarette Demand (Cigarette Purchase Task)
|
-2.4 number of cigarettes
Standard Deviation 2.61
|
-1.20 number of cigarettes
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: baseline (Week 0) to study endpoint (Week 10)Population: Participants who have pre- and post- treatment data.
Self-reported drinks per day averaged across study week.
Outcome measures
| Measure |
Semaglutide
n=21 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=18 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Daily Alcohol Use
|
-1.43 daily drinks
Standard Deviation 1.51
|
-0.81 daily drinks
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: baseline (Week 0) to study endpoint (Week 10)Population: Participants who reported cigarette use at baseline and have pre- and post-treatment data.
Self-reported cigarettes per day
Outcome measures
| Measure |
Semaglutide
n=5 Participants
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=4 Participants
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Change in Daily Cigarette Use
|
-2.48 daily cigarettes
Standard Deviation 4.22
|
-1.30 daily cigarettes
Standard Deviation 2.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (Week 0) to study endpoint (Week 10)Change in 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
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (Week 0) to post-medication (Week 8)Rate of alcohol elimination following an alcohol challenge procedure
Outcome measures
Outcome data not reported
Adverse Events
Semaglutide
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Sham/Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Semaglutide
n=24 participants at risk
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks.
Semaglutide: Semaglutide (subcutaneous)
|
Sham/Placebo
n=24 participants at risk
Participants will receive sham subcutaneous injections over 9 weeks.
Sham/placebo: Sham subcutaneous injection
|
|---|---|---|
|
Nervous system disorders
Decreased Appetite
|
75.0%
18/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
41.7%
10/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Nausea
|
70.8%
17/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
4/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
12/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
8.3%
2/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Headache
|
50.0%
12/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
20.8%
5/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
10/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
37.5%
9/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Fatigue
|
37.5%
9/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
25.0%
6/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
6/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
4/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
8.3%
2/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Insomnia
|
12.5%
3/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
20.8%
5/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Increased Appetite
|
8.3%
2/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
16.7%
4/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Nervous system disorders
Nervousness/Anxiety
|
8.3%
2/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
29.2%
7/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
12.5%
3/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
Psychiatric disorders
Depression
|
4.2%
1/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
8.3%
2/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
|
General disorders
Increased Libido
|
4.2%
1/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
8.3%
2/24 • From the Baseline medical visit through follow-up, a total of up to 12 weeks.
|
Additional Information
Christian Hendershot
University of North Carolina at Chapel Hill
Phone: (213) 821-0769
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place