parallel randomized trial

NCT05520775

Human Laboratory Screening of Semaglutide for Alcohol Use Disorder

Design

Randomized: 48
Start year: 2022
Treatment: 9 weeks, follow-up 10 weeks
Countries: United States (1 sites)
Sponsor: University of North Carolina, Chapel Hill (non industry)
Eligibility: age 21 to 65; current DSM-5 AUD not seeking treatment; BMI 23 or higher; no diabetes

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo (sham injection)	lifestyle: none	24	24	19
A2	Semaglutide 0.5 mg subcutaneous once weekly Semaglutide	lifestyle: none	24	24	23

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Semaglutide 0.5 mg subcutaneous once weekly A2
age	mean (years)	39.0	40.6
age	sd (years)	10.9	10.5
asian	n	2	0
asian	percent	8
black	n	4	3
black	percent	17	13
bmi	mean (kg/m2)	31.7	32.4
bmi	sd (kg/m2)	4.5	6.7
female	n	17	17
female	percent	71	71
hba1c	mean (percent)	5.16	5.09
hba1c	sd (percent)	0.35	0.38
hispanic	n	2	2
hispanic	percent	8	8
other audit	mean (points)	14.2	12.7
other audit	sd (points)	6.5	5.6
other current smoking	n	7	6
other current smoking	percent	29	25
other drinks per calendar day	mean (drinks)	3.0	2.7
other drinks per calendar day	sd (drinks)	1.7	1.7
other heavy drinking days 28d	mean (days)	9.8	8.4
other heavy drinking days 28d	sd (days)	5.5	7.9
other race native hawaiian pacific islander	n	0	0
sbp	mean (mmHg)	127.9	125.1
sbp	sd (mmHg)	18.7	16.2
weight	mean (kg)	93.1	95.4
weight	sd (kg)	15.1	20.9
white	n	18	21
white	percent	75	88

12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 24	not stated; safety; R0005391:Supplement eTable 1
	A2	events				0 / 24	not stated; safety; R0005391:Supplement eTable 1

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 24	not stated; safety; R0005391:Supplement eTable 1
	A2	events				0 / 24	not stated; safety; R0005391:Supplement eTable 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 24	not stated; safety; R0005391:Supplement eTable 1
	A2	events				17 / 24	not stated; safety; R0005391:Supplement eTable 1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 24	not stated; safety; R0005391:Supplement eTable 1
	A2	events				2 / 24	not stated; safety; R0005391:Supplement eTable 1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 24	not stated; safety; R0005391:Supplement eTable 1
	A2	events				10 / 24	not stated; safety; R0005391:Supplement eTable 1

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 24	not stated; safety; R0005391:Supplement eTable 1
	A2	events				12 / 24	not stated; safety; R0005391:Supplement eTable 1