parallel randomized trial

S003425

Design

Randomized: 115
Start year
Treatment: 13.04 weeks, follow-up 13.04 weeks
Countries: Ukraine (1 sites)
Sponsor: (non industry)
Eligibility: age 26 to 67 years; MASLD by steatometry plus one cardiometabolic criterion

Arm	Treatment	Background	Randomized	Analyzed
A1	Standard care or no added treatment Control group lifestyle advice only	Mediterranean diet and 150 min weekly moderate activity; lifestyle: standard	36	36
A2	Dapagliflozin Group IA dapagliflozin	Mediterranean diet and 150 min weekly moderate activity; lifestyle: standard	41	41
A3	Liraglutide 1.8 mg subcutaneous once daily Group IB liraglutide	Mediterranean diet and 150 min weekly moderate activity; lifestyle: standard	38	38

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

Characteristic	Statistic	Standard care or no added treatment A1	Dapagliflozin A2	Liraglutide 1.8 mg subcutaneous once daily A3
age: 25 to 34	n	8	12	10
age: 25 to 34	percent	22.2	29.3	26.3
age: 35 to 44	n	11	13	13
age: 35 to 44	percent	30.6	31.7	34.2
age: 45 to 54	n	12	10	9
age: 45 to 54	percent	33.3	24.4	23.7
age: 55 to 67	n	5	6	6
age: 55 to 67	percent	13.9	14.6	15.8
age	mean (years)	43.3	41.7	39.6
age	sd (years)	11.0	10.7	11.2
bmi	mean (kg/m2)	30.95	31.61	32.16
bmi	sd (kg/m2)	3.40	3.10	4.40
female	n	11	17	8
female	percent	31	41	21
other diabetes	n	23	28	23
other diabetes	percent	63.9	68.3	60.5
other steatosis severity: s1	n	9	14	8
other steatosis severity: s1	percent	25	34.2	21.1
other steatosis severity: s2	n	14	12	18
other steatosis severity: s2	percent	38.9	29.3	47.4
other steatosis severity: s3	n	13	15	12
other steatosis severity: s3	percent	36.1	36.5	31.5
sbp	mean (mmHg)	132.5	133.7	132.2
sbp	sd (mmHg)	13.6	16.6	15.6

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

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 41	not stated; randomized; R0040388:Results
	A3	events				0 / 38	not stated; randomized; R0040388:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				7 / 38	not stated; randomized; nausea and diarrhea; R0040388:p3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 41	not stated; randomized; R0040388:p3
	A3	events				0 / 38	not stated; randomized; R0040388:p3