parallel randomized trial

NCT05530577

Effects of Semaglutide on Nicotine Intake and Smoking Lapse

Design

Randomized: 24
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; 5 or more cigarettes per day; CO 8 ppm or more; not seeking cessation; BMI 23 or higher; no diabetes

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo (sham injection)	lifestyle: not reported	12
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide escalating to 1.0 mg weekly	lifestyle: not reported	12

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

Characteristic	Statistic	Placebo A1	Semaglutide 1.0 mg subcutaneous once weekly A2
age	mean (years)	44	44
age	sd (years)	13	11
asian	n	0	0
black	n	2	2
black	percent	17	17
bmi	mean (kg/m2)	31.5	35.6
bmi	sd (kg/m2)	5.6	8.1
female	n	10	10
female	percent	83	83
hba1c	mean (percent)	5.25	5.19
hba1c	sd (percent)	0.37	0.50
hispanic	n	2	2
hispanic	percent	17	17
other cigarettes per day	mean (cigarettes)	18.8	12.0
other cigarettes per day	sd (cigarettes)	8.6	5.6
other ftnd	mean (points)	12.2	11.9
other ftnd	sd (points)	6.5	4.7
other race native hawaiian pacific islander	n	0	0
other race other or multiracial	n	0	0
sbp	mean (mmHg)	133.9	121.3
sbp	sd (mmHg)	15.5	19.1
weight	mean (kg)	88.6	98.2
weight	sd (kg)	17.4	20.6
white	n	10	10
white	percent	83	83

14 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 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1
	A2	events				0 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1
	A2	events				1 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1
	A2	events				9 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1
	A2	events				3 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1
	A2	events				5 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1
	A2	events				3 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1
	A2	events				1 / 12	not stated; randomized; R0003312:Supplement 2 eTable 1