parallel randomized trial

NCT04019197

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy

Design

Randomized: 108
Start year: 2019
Treatment: 32 weeks, follow-up 56 weeks
Countries: United States (1 sites)
Sponsor: Case Western Reserve University (non industry)
Eligibility: age 18 or older; BMI 25 or more; HIV on stable ART; lipohypertrophy; no diabetes or CVD

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide	stable antiretroviral therapy; lifestyle: standard	54	54
A2	Placebo Placebo	stable antiretroviral therapy; lifestyle: standard	54	54

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

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Placebo A2
age	median (years)	53	53
age	q1 (years)	40	41
age	q3 (years)	57	57
asian	n	0	0
black	n	33	34
black	percent	61.1	60.0
bmi	median (kg/m2)	32.80	33.09
bmi	q1 (kg/m2)	28.61	28.99
bmi	q3 (kg/m2)	35.93	39.73
female	n	16	27
female	percent	30	50.0
hba1c	median (percent)	5.4	5.6
hba1c	q1 (percent)	5.1	5.4
hba1c	q3 (percent)	5.8	5.9
hispanic	n	4	5
hispanic	percent	7.0	9.0
other race american indian alaska native	n	1	0
other race american indian alaska native	percent	1.9	0.0
other race multiple	n	0	2
other race multiple	percent	0.0	3.7
other race native hawaiian pacific islander	n	0	0
white	n	20	18
white	percent	37.0	33.3

30 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				1 / 54	while on treatment; safety; registry:adverse_events
	A2	events				0 / 54	while on treatment; safety; registry:adverse_events

Discontinuation due to adverse events (12 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 54	not stated; randomized; registry:outcomes
A1	events	1 / 54	not stated; randomized; grade 1 elevated lipase, gastrointestinal symptoms (week 10); registry:outcomes
A1	events	1 / 54	not stated; randomized; grade 1 gastrointestinal and systemic symptoms (week 12); registry:outcomes
A1	events	0 / 54	not stated; randomized; grade 1 memory impairment (week 17); registry:outcomes
A1	events	1 / 54	not stated; randomized; grade 4 elevated lipase (week 14); registry:outcomes
A1	events	1 / 54	not stated; randomized; weight loss (week 17); registry:outcomes
A2	events	1 / 54	not stated; randomized; registry:outcomes
A2	events	0 / 54	not stated; randomized; grade 1 elevated lipase, gastrointestinal symptoms (week 10); registry:outcomes
A2	events	0 / 54	not stated; randomized; grade 1 gastrointestinal and systemic symptoms (week 12); registry:outcomes
A2	events	1 / 54	not stated; randomized; grade 1 memory impairment (week 17); registry:outcomes
A2	events	0 / 54	not stated; randomized; grade 4 elevated lipase (week 14); registry:outcomes
A2	events	0 / 54	not stated; randomized; weight loss (week 17); registry:outcomes

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				21 / 54	while on treatment; safety; registry:adverse_events
	A2	events				11 / 54	while on treatment; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 54	while on treatment; safety; registry:adverse_events
	A2	events				3 / 54	while on treatment; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 54	while on treatment; safety; registry:adverse_events
	A2	events				17 / 54	while on treatment; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				17 / 54	while on treatment; safety; constipation or irregular bowel movements; registry:adverse_events
	A2	events				7 / 54	while on treatment; safety; constipation or irregular bowel movements; registry:adverse_events

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	1 / 54	not stated; randomized; grade 1 elevated lipase, gastrointestinal symptoms (week 10); registry:outcomes
A1	events	1 / 54	not stated; randomized; grade 1 gastrointestinal and systemic symptoms (week 12); registry:outcomes
A2	events	0 / 54	not stated; randomized; grade 1 elevated lipase, gastrointestinal symptoms (week 10); registry:outcomes
A2	events	0 / 54	not stated; randomized; grade 1 gastrointestinal and systemic symptoms (week 12); registry:outcomes

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 54	not stated; randomized; cholelithiasis; registry:outcomes
	A2	events				0 / 54	not stated; randomized; cholelithiasis; registry:outcomes

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 54	while on treatment; safety; registry:adverse_events
	A2	events				0 / 54	while on treatment; safety; registry:adverse_events