Trial Outcomes & Findings for Manipulating Ghrelin Signaling Via GOAT Inhibition in Alcohol Use Disorder (NCT NCT03896516)
NCT ID: NCT03896516
Last Updated: 2025-01-15
Results Overview
Number of participants with adverse events related to intervention. Adverse events were collected from participants self reporting.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to one month
Results posted on
2025-01-15
Participant Flow
Participant milestones
| Measure |
GLWL-01, Then Placebo
Participants receive GLWL-01 450 mg orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then placebo orally twice daily for a minimum of four days (stage II).
|
Placebo, Then GLWL-01
Participants receive placebo orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then GLWL-01 450 mg orally twice daily for a minimum of four days (stage II).
|
|---|---|---|
|
Stage I (GLWL-01 or Placebo)
STARTED
|
11
|
10
|
|
Stage I (GLWL-01 or Placebo)
COMPLETED
|
9
|
9
|
|
Stage I (GLWL-01 or Placebo)
NOT COMPLETED
|
2
|
1
|
|
Washout Period
STARTED
|
9
|
9
|
|
Washout Period
COMPLETED
|
6
|
8
|
|
Washout Period
NOT COMPLETED
|
3
|
1
|
|
Stage II (GLWL-01 or Placebo)
STARTED
|
6
|
8
|
|
Stage II (GLWL-01 or Placebo)
COMPLETED
|
6
|
7
|
|
Stage II (GLWL-01 or Placebo)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
GLWL-01, Then Placebo
Participants receive GLWL-01 450 mg orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then placebo orally twice daily for a minimum of four days (stage II).
|
Placebo, Then GLWL-01
Participants receive placebo orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then GLWL-01 450 mg orally twice daily for a minimum of four days (stage II).
|
|---|---|---|
|
Stage I (GLWL-01 or Placebo)
Withdrawal by Subject
|
1
|
0
|
|
Stage I (GLWL-01 or Placebo)
Physician Decision
|
1
|
1
|
|
Washout Period
Physician Decision
|
3
|
1
|
|
Stage II (GLWL-01 or Placebo)
Physician Decision
|
0
|
1
|
Baseline Characteristics
Manipulating Ghrelin Signaling Via GOAT Inhibition in Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
All Study Participants
n=21 Participants
Participants were randomized to receive either GLWL-01 450 mg or placebo orally twice daily for a minimum of four days (Stage 1) followed by a minimum of two day wash-out period then cross over to receive subsequent treatment for a minimum of four days (stage II).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to one monthPopulation: The analysis includes all participants who received the study interventions in each stage of the study.
Number of participants with adverse events related to intervention. Adverse events were collected from participants self reporting.
Outcome measures
| Measure |
GLWL-01
n=19 Participants
Participants receive GLWL-01 450 mg orally twice daily for a minimum of four days.
|
Placebo
n=16 Participants
Participants receive placebo orally twice daily for a minimum of four days.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
18 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: AUQ scores were collected 5-6 days per intervention [initial dosing days (2-3 days), the virtual reality buffet day (1 day), the cue-reactivity day (1 day), and the final study day (1 day)]Population: The analysis includes all participants who received the study interventions in each stage of the study.
Alcohol cue elicited craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). Higher score indicated higher alcohol craving. AUQ was collected on each initial dosing days (2-3 days), the virtual reality buffet day (1 day), the cue-reactivity day (1 day), and the final study day (1 day), for a total of 5-6 days per intervention. The least squares average for each intervention was calculated using a linear mixed effects model including a random intercept for each participant.
Outcome measures
| Measure |
GLWL-01
n=19 Participants
Participants receive GLWL-01 450 mg orally twice daily for a minimum of four days.
|
Placebo
n=16 Participants
Participants receive placebo orally twice daily for a minimum of four days.
|
|---|---|---|
|
Alcohol Cue-elicited Craving Assessed in a "Bar-like" Laboratory
|
17.8 units on a scale
Standard Error 2.17
|
19.8 units on a scale
Standard Error 2.19
|
Adverse Events
GLWL-01
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GLWL-01
n=21 participants at risk
Participants receive GLWL-01 450 mg orally twice daily for a minimum of four days.
|
Placebo
n=21 participants at risk
Participants receive placebo orally twice daily for a minimum of four days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.8%
1/21 • Number of events 1 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Cardiac disorders
Palpitations
|
9.5%
2/21 • Number of events 2 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Eye disorders
Eye movement disorder
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Eye disorders
Eye symptom
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
7/21 • Number of events 7 • Up to one month
|
9.5%
2/21 • Number of events 2 • Up to one month
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
3/21 • Number of events 4 • Up to one month
|
9.5%
2/21 • Number of events 2 • Up to one month
|
|
Gastrointestinal disorders
Abnormal faeces
|
9.5%
2/21 • Number of events 2 • Up to one month
|
9.5%
2/21 • Number of events 2 • Up to one month
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 1 • Up to one month
|
4.8%
1/21 • Number of events 3 • Up to one month
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • Up to one month
|
4.8%
1/21 • Number of events 2 • Up to one month
|
|
Gastrointestinal disorders
Dyspepsia
|
19.0%
4/21 • Number of events 5 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • Number of events 4 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
General disorders
Fatigue
|
23.8%
5/21 • Number of events 8 • Up to one month
|
38.1%
8/21 • Number of events 10 • Up to one month
|
|
General disorders
Hot flush
|
4.8%
1/21 • Number of events 2 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Number of events 2 • Up to one month
|
23.8%
5/21 • Number of events 6 • Up to one month
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
3/21 • Number of events 3 • Up to one month
|
14.3%
3/21 • Number of events 4 • Up to one month
|
|
Investigations
Blood potassium decreased
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Investigations
Blood potassium increased
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Investigations
Electrocardiogram abnormal
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Investigations
Electrocardiogram QT interval abnormal
|
23.8%
5/21 • Number of events 6 • Up to one month
|
9.5%
2/21 • Number of events 2 • Up to one month
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
3/21 • Number of events 3 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Metabolism and nutrition disorders
Increased appetite
|
14.3%
3/21 • Number of events 3 • Up to one month
|
14.3%
3/21 • Number of events 3 • Up to one month
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
4.8%
1/21 • Number of events 1 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 1 • Up to one month
|
14.3%
3/21 • Number of events 3 • Up to one month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.5%
2/21 • Number of events 2 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 3 • Up to one month
|
9.5%
2/21 • Number of events 2 • Up to one month
|
|
Nervous system disorders
Headache
|
28.6%
6/21 • Number of events 8 • Up to one month
|
14.3%
3/21 • Number of events 5 • Up to one month
|
|
Nervous system disorders
Insomnia
|
28.6%
6/21 • Number of events 7 • Up to one month
|
23.8%
5/21 • Number of events 6 • Up to one month
|
|
Nervous system disorders
Somnolence
|
4.8%
1/21 • Number of events 2 • Up to one month
|
23.8%
5/21 • Number of events 8 • Up to one month
|
|
Nervous system disorders
Tension headache
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Nervous system disorders
Vision blurred
|
4.8%
1/21 • Number of events 1 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Psychiatric disorders
Mental status changes
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
2/21 • Number of events 2 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
|
Vascular disorders
Haematoma
|
4.8%
1/21 • Number of events 1 • Up to one month
|
19.0%
4/21 • Number of events 4 • Up to one month
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • Up to one month
|
0.00%
0/21 • Up to one month
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/21 • Up to one month
|
4.8%
1/21 • Number of events 1 • Up to one month
|
Additional Information
Dr Lorenzo Leggio, M.D., Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 1-667-312-5188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place