parallel randomized trial

NCT06309992

Multicentre, Randomised, Double-blind, Placebo-controlled, 48-week, Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis (NASH)

Metabolic dysfunction associated steatotic liver disease or steatohepatitis NCT06309992S001918

Design

Randomized: 218
Start year: 2024
Treatment: 48 weeks, follow-up 51 weeks
Countries: United States, Spain (32 sites)
Sponsor: Boehringer Ingelheim (industry)
Eligibility: age 18 or more; BMI 30 or more, or 27 with complication; MRI-PDFF 8 percent or more plus NIT or biopsy MASH

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: yes
Primary estimand: treatment policy
Analysis population: modified itt
Missing data: multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Survodutide 6.0 mg subcutaneous once weekly Survodutide 6.0 mg	lifestyle: standard	146	146	86
A2	Placebo Placebo	lifestyle: standard	72	70	42

Baseline characteristics

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

Characteristic	Statistic	Survodutide 6.0 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	56.0	55.4
age	sd (years)	12.4	12.9
asian	n	1	1
asian	percent	0.7	1.4
black	n	13	3
black	percent	8.9	4.3
bmi	mean (kg/m2)	39.0	40.7
bmi	sd (kg/m2)	7.9	7.7
egfr	mean (mL/min/1.73 m2)	85.8	82.8
egfr	sd (mL/min/1.73 m2)	18.1	18.0
established cvd	n	7	2
established cvd	percent	4.8	2.9
female	n	92	39
female	percent	63.0	55.7
hba1c	mean (percent)	6.2	6.2
hba1c	sd (percent)	1.1	1.1
hispanic	n	59	29
hispanic	percent	40.4	41.4
other race american indian alaska native	n	0	1
other race american indian alaska native	percent	0.0	1.4
other race multiple	n	0	1
other race multiple	percent	0.0	1.4
other race native hawaiian pacific islander	n	0	0
other race native hawaiian pacific islander	percent	0.0	0.0
sbp	mean (mmHg)	127.7	128.9
sbp	sd (mmHg)	12.4	14.3
waist	mean (cm)	119.8	123.3
waist	sd (cm)	13.7	14.3
weight	mean (kg)	106.6	111.9
weight	sd (kg)	23.3	20.5
white	n	132	64
white	percent	90.4	91.4

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
48	A1 vs A2	md	-0.8 percent	-1.1 to -0.4		while on treatment; modified itt; diabetes:t2d; R0011245:Table 2
48	A1	change	-0.6 percent		33	while on treatment; modified itt; diabetes:t2d; R0011245:Table 2
48	A2	change	0.2 percent		16	while on treatment; modified itt; diabetes:t2d; R0011245:Table 2

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
48	A1	change	-6.7 mmHg		86	while on treatment; modified itt; R0011245:Table 2
48	A1 vs A2	md	-7.4 mmHg	-11.3 to -3.4		while on treatment; modified itt; R0011245:Table 2
48	A2	change	0.7 mmHg		41	while on treatment; modified itt; R0011245:Table 2

Percent body weight change (10 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	percent change	-9.9 percent	8.2		33	while on treatment; modified itt; diabetes:t2d; R0011245:Extended Data Table 3
48	A1	percent change	-12.2 percent			84	hypothetical; modified itt; R0011245:Fig. 2e
48	A1 vs A2	md	-11.2 percent		-13.4 to -9.0		hypothetical; modified itt; R0011245:Fig. 2e
48	A1	percent change	-8.7 percent			119	treatment policy; modified itt; R0011245:Fig. 2e
48	A1 vs A2	md	-7.3 percent		-9.4 to -5.2		treatment policy; modified itt; R0011245:Fig. 2e
48	A1	percent change	-13.4 percent	7.0		53	while on treatment; modified itt; diabetes:none; R0011245:Extended Data Table 3
48	A2	percent change	-1.4 percent			53	treatment policy; modified itt; R0011245:Fig. 2e
48	A2	percent change	-1.2 percent	4.0		26	while on treatment; modified itt; diabetes:none; R0011245:Extended Data Table 3
48	A2	percent change	-1.0 percent			41	hypothetical; modified itt; R0011245:Fig. 2e
48	A2	percent change	-2.0 percent	4.3		16	while on treatment; modified itt; diabetes:t2d; R0011245:Extended Data Table 3

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	responders				68 / 86	while on treatment; modified itt; R0011245:Fig. 2f
48	A2	responders				6 / 42	while on treatment; modified itt; R0011245:Fig. 2f

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	responders				53 / 86	while on treatment; modified itt; R0011245:Fig. 2f
48	A2	responders				2 / 42	while on treatment; modified itt; R0011245:Fig. 2f

Weight loss of 15 percent or more (2 lines; O11C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	responders				29 / 86	while on treatment; modified itt; R0011245:Fig. 2f
48	A2	responders				0 / 42	while on treatment; modified itt; R0011245:Fig. 2f

Weight loss of 20 percent or more (2 lines; O11D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
48	A1	responders				10 / 86	while on treatment; modified itt; R0011245:Fig. 2f
48	A2	responders				0 / 42	while on treatment; modified itt; R0011245:Fig. 2f

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				3 / 70	while on treatment; safety; R0011245:Table 3

All cause mortality (1 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 70	while on treatment; safety; R0011245:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				8 / 70	while on treatment; safety; R0011245:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 146	not stated; modified itt; R0011245:Fig. 1
A1	events	34 / 146	while on treatment; safety; R0011245:Table 3
A2	events	1 / 70	not stated; modified itt; R0011245:Fig. 1
A2	events	7 / 70	while on treatment; safety; R0011245:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				82 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				10 / 70	while on treatment; safety; R0011245:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				62 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				5 / 70	while on treatment; safety; R0011245:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				43 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				7 / 70	while on treatment; safety; R0011245:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				41 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				7 / 70	while on treatment; safety; R0011245:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				29 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				3 / 70	while on treatment; safety; R0011245:Table 3

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 146	while on treatment; safety; cholecystitis; R0011245:Table 3
A1	events	1 / 146	while on treatment; safety; cholelithiasis; R0011245:Table 3
A2	events	0 / 70	while on treatment; safety; cholecystitis; R0011245:Table 3
A2	events	0 / 70	while on treatment; safety; cholelithiasis; R0011245:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				0 / 70	while on treatment; safety; R0011245:Table 3

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				0 / 70	while on treatment; safety; R0011245:Table 3

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	while on treatment; safety; R0011245:Results

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				2 / 70	while on treatment; safety; R0011245:Table 3

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	while on treatment; safety; R0011245:Table 3
	A2	events				1 / 70	while on treatment; safety; R0011245:Table 3