parallel randomized trial

NCT05292911

A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Design

Randomized: 64
Start year: 2022
Treatment: 24 weeks, follow-up 27.57 weeks
Countries: United States (13 sites)
Sponsor: Altimmune (industry)
Eligibility: adults 18 to 65, BMI 28 or more, liver fat 10 percent or more; completers of parent trial

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: none	19	19	18
A2	Pemvidutide 1.2 mg subcutaneous once weekly Pemvidutide 1.2 mg	lifestyle: none	16	16	14
A3	Pemvidutide 1.8 mg subcutaneous once weekly Pemvidutide 1.8 mg	lifestyle: none	15	15	13
A4	Pemvidutide 2.4 mg subcutaneous once weekly Pemvidutide 2.4 mg	lifestyle: none	14	14	11

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

Characteristic	Statistic	Placebo A1	Pemvidutide 1.2 mg subcutaneous once weekly A2	Pemvidutide 1.8 mg subcutaneous once weekly A3	Pemvidutide 2.4 mg subcutaneous once weekly A4
age	mean (years)	49.0	48.6	49.9	48.4
age	sd (years)	15	11	10	8
bmi	mean (kg/m2)	37.1	36.7	36.0	37.0
bmi	sd (kg/m2)	4.9	6.1	3.8	5.3
female	n	11	7	8	8
female	percent	57.9	43.8	53.3	57.1
hispanic	n	11	15	12	9
hispanic	percent	57.9	93.8	80.0	64.3
other t2d	n	5	3	6	3
other t2d	percent	26.3	18.8	40.0	21.4
sbp	mean (mmHg)	122.7	128.6	123.8	127.6
sbp	sd (mmHg)	10.3	16.0	17.4	9.9
weight	mean (kg)	104.4	101.4	100.9	107.4
weight	sd (kg)	21.2	16.3	13.2	17.2

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

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A2	events	0 / 16	not stated; safety; R0010027:Table 3
A3	events	0 / 15	not stated; safety; R0010027:Table 3
A4	events	0 / 14	not stated; safety; R0010027:Table 3

Discontinuation due to adverse events (8 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A2	events	2 / 16	not stated; safety; R0010027:Table 3
A2	events	0 / 16	not stated; safety; R0010027:Table 3
A3	events	1 / 15	not stated; safety; R0010027:Table 3
A3	events	0 / 15	not stated; safety; R0010027:Table 3
A4	events	0 / 14	not stated; safety; R0010027:Table 3
A4	events	0 / 14	not stated; safety; R0010027:Table 3

Nausea (8 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	2 / 19	not stated; safety; R0010027:Table 3
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A2	events	2 / 16	not stated; safety; R0010027:Table 3
A2	events	1 / 16	not stated; safety; R0010027:Table 3
A3	events	3 / 15	not stated; safety; R0010027:Table 3
A3	events	4 / 15	not stated; safety; R0010027:Table 3
A4	events	4 / 14	not stated; safety; R0010027:Table 3
A4	events	1 / 14	not stated; safety; R0010027:Table 3

Vomiting (8 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A2	events	1 / 16	not stated; safety; R0010027:Table 3
A2	events	0 / 16	not stated; safety; R0010027:Table 3
A3	events	1 / 15	not stated; safety; R0010027:Table 3
A3	events	0 / 15	not stated; safety; R0010027:Table 3
A4	events	1 / 14	not stated; safety; R0010027:Table 3
A4	events	0 / 14	not stated; safety; R0010027:Table 3

Diarrhea (8 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	4 / 19	not stated; safety; R0010027:Table 3
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A2	events	2 / 16	not stated; safety; R0010027:Table 3
A2	events	1 / 16	not stated; safety; R0010027:Table 3
A3	events	5 / 15	not stated; safety; R0010027:Table 3
A3	events	0 / 15	not stated; safety; R0010027:Table 3
A4	events	1 / 14	not stated; safety; R0010027:Table 3
A4	events	0 / 14	not stated; safety; R0010027:Table 3

Constipation (8 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 19	not stated; safety; R0010027:Table 3
A1	events	1 / 19	not stated; safety; R0010027:Table 3
A2	events	2 / 16	not stated; safety; R0010027:Table 3
A2	events	1 / 16	not stated; safety; R0010027:Table 3
A3	events	3 / 15	not stated; safety; R0010027:Table 3
A3	events	0 / 15	not stated; safety; R0010027:Table 3
A4	events	0 / 14	not stated; safety; R0010027:Table 3
A4	events	0 / 14	not stated; safety; R0010027:Table 3