parallel randomized trial

NCT05407961

A Phase 1b, 2-Part, Investigator- and Participant-Blind, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3532226 in Participants With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT05407961S000034

Design

Randomized: 72
Start year: 2022
Treatment: 12 weeks, follow-up 16 weeks
Countries: Germany (1 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: Age 18 to 70; BMI 23 to 45; HbA1c 7.0 to 10.0 on metformin or diet, 6.0 to 9.5 on DPP-4 or SGLT2 inhibitor (washed out)

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: MMRM for HbA1c; ANCOVA on observed data otherwise

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Macupatide Macupatide 20 mg plus placebo	metformin if taken at baseline; lifestyle: not reported	15	15
A2	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg plus placebo	metformin if taken at baseline; lifestyle: not reported	29	29
A3	Dulaglutide with macupatide 1.5 to 20 mg injection once weekly Macupatide 20 mg plus dulaglutide 1.5 mg	metformin if taken at baseline; lifestyle: not reported	28	28

Baseline characteristics

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

Characteristic	Statistic	Macupatide A1	Dulaglutide 1.5 mg subcutaneous once weekly A2	Dulaglutide with macupatide 1.5 to 20 mg injection once weekly A3
age	mean (years)	58	62	61
age	sd (years)	11.4	7.3	7.4
black	n	0	0	1
black	percent			4
bmi	mean (kg/m2)	29.2	30.7	29.4
bmi	sd (kg/m2)	2.7	4.3	3.7
diabetes duration	mean (years)	13.1	11.4	12.7
diabetes duration	sd (years)	7.5	9.0	7.8
hba1c	mean (percent)	7.6	7.6	7.4
hba1c	sd (percent)	0.7	0.8	0.6
metformin use	n	15	29	26
metformin use	percent	100	100	93
other male	n	14	22	19
other male	percent	93	76	68
weight	mean (kg)	91.3	92.7	87.4
weight	sd (kg)	14.1	15.6	9.4
white	n	15	29	27
white	percent	100	100	96

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.7 percent	0.1		15	not stated; modified itt; R0015193:Table 3
12	A2	change	-1.1 percent	0.1		29	not stated; modified itt; R0015193:Table 3
12	A2 vs A1	md	-0.4 percent		-0.8 to -0.1		not stated; modified itt; R0015193:Table 3
12	A3	change	-1.3 percent	0.1		28	not stated; modified itt; R0015193:Table 3
12	A3 vs A1	md	-0.7 percent		-1.0 to -0.4		not stated; modified itt; R0015193:Table 3
12	A3 vs A2	md	-0.2 percent		-0.5 to 0.1		not stated; modified itt; R0015193:Table 3

Percent body weight change (6 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	percent change	-3.8 percent	1.0		15	not stated; modified itt; R0015193:Table 3
12	A2	percent change	-3.2 percent	0.7		29	not stated; modified itt; R0015193:Table 3
12	A2 vs A1	md	0.5 percent		-1.9 to 3.0		not stated; modified itt; R0015193:Table 3
12	A3	percent change	-6.2 percent	0.8		28	not stated; modified itt; R0015193:Table 3
12	A3 vs A1	md	-2.5 percent		-4.9 to 0.0		not stated; modified itt; R0015193:Table 3
12	A3 vs A2	md	-3.0 percent		-5.1 to -0.9		not stated; modified itt; R0015193:Table 3

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; safety; R0015193:Table 2
A2	events	0 / 29	not stated; safety; R0015193:Table 2
A3	events	0 / 28	not stated; safety; R0015193:Table 2

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; safety; R0015193:Table 2
A2	events	0 / 29	not stated; safety; R0015193:Table 2
A3	events	1 / 28	not stated; safety; R0015193:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; safety; R0015193:Table 2
A2	events	0 / 29	not stated; safety; R0015193:Table 2
A3	events	2 / 28	not stated; safety; R0015193:Table 2

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 15	not stated; safety; R0015193:Table 2
A2	events	5 / 29	not stated; safety; R0015193:Table 2
A3	events	2 / 28	not stated; safety; R0015193:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 15	not stated; safety; R0015193:Table 2
A2	events	2 / 29	not stated; safety; R0015193:Table 2
A3	events	2 / 28	not stated; safety; R0015193:Table 2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	4 / 15	not stated; safety; R0015193:Table 2
A2	events	5 / 29	not stated; safety; R0015193:Table 2
A3	events	7 / 28	not stated; safety; R0015193:Table 2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; safety; R0015193:Table 2
A2	events	3 / 29	not stated; safety; R0015193:Table 2
A3	events	1 / 28	not stated; safety; R0015193:Table 2