parallel randomized trial

NCT05654831

A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, First-Time-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT05654831S002988

Design

Randomized: 52
Start year: 2022
Treatment: 4 weeks, follow-up 4.86 weeks
Countries: United States (2 sites)
Sponsor: Eccogene (industry)
Eligibility: MAD: age 18 to 70; BMI 24 to 40; HbA1c 7.0 to 10.5 percent; T2DM on metformin or lifestyle

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: safety
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	ECC5004 5 mg tablet once daily ECC5004 5 mg	metformin; lifestyle: none	9	9
A2	ECC5004 10 mg tablet once daily ECC5004 10 mg	metformin; lifestyle: none	10	9
A3	ECC5004 30 mg tablet once daily ECC5004 30 mg	metformin; lifestyle: none	10	10
A4	ECC5004 50 mg tablet once daily ECC5004 50 mg	metformin; lifestyle: none	10	10
A5	Placebo Placebo	metformin; lifestyle: none	13	13

Baseline characteristics

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

Characteristic	Statistic	ECC5004 5 mg tablet once daily A1	ECC5004 10 mg tablet once daily A2	ECC5004 30 mg tablet once daily A3	ECC5004 50 mg tablet once daily A4	Placebo A5
age	mean (years)	50.1	60.3	59.1	56.5	54.8
age	sd (years)	4.91	5.83	5.55	7.60	11.45
asian	n	1	1	0	0	0
asian	percent	11.1	11.1
black	n	1	1	2	1	3
black	percent	11.1	11.1	20.0	10.0	23.1
bmi	mean (kg/m2)	33.6	30.7	31.0	31.1	32.2
bmi	sd (kg/m2)	3.4	3.0	4.4	2.6	3.9
diabetes duration	mean (years)	4.8	10.4	12.4	7.4	8.5
diabetes duration	sd (years)	2.9	6.5	5.6	6.3	5.2
hba1c	mean (percent)	8.0	8.6	8.6	9.1	8.7
hba1c	sd (percent)	0.9	1.0	0.8	1.1	0.8
hispanic	n	8	4	5	8	8
hispanic	percent	88.9	44.4	50.0	80.0	61.5
other ethnicity chinese	n	0	1	0	0	0
other ethnicity chinese	percent		11.1
other ethnicity cuban	n	0	2	3	1	1
other ethnicity cuban	percent		22.2	30.0	10.0	7.7
other ethnicity other	n	1	0	0	0	0
other ethnicity other	percent	11.1
other ethnicity south american	n	0	1	0	0	0
other ethnicity south american	percent		11.1
other male	n	6	6	4	6	6
other male	percent	66.7	66.7	40.0	60.0	46.2
other not hispanic	n	0	1	2	1	4
other not hispanic	percent		11.1	20.0	10.0	30.8
other race other	n	0	0	1	0	0
other race other	percent			10.0
waist	mean (cm)	106.7	103.8	103.3	103.8	104.2
waist	sd (cm)	7.9	7.6	8.5	7.8	10.7
weight	mean (kg)	98.72	87.66	80.15	81.33	86.10
weight	sd (kg)	16.1	13.6	11.2	6.8	16.4
white	n	7	7	7	9	10
white	percent	77.8	77.8	70.0	90.0	76.9

Analyses this trial contributes to

Results

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

Body weight change in kilograms (diabetes) (8 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
3.86	A1	change	-2.99 kg	-3.99 to -1.99	9	not stated; other; R0007796:Supplement Table S7
3.86	A2	change	-3.28 kg	-4.58 to -1.99	9	not stated; other; R0007796:Supplement Table S7
3.86	A3	change	-4.03 kg	-4.71 to -3.35	9	not stated; other; R0007796:Supplement Table S7
3.86	A4	change	-4.80 kg	-6.22 to -3.38	9	not stated; other; R0007796:Supplement Table S7
3.86	A5	change	-6.51 kg	-8.77 to -4.26	3	not stated; other; group:cohort_10_mg; R0007796:Supplement Table S7
3.86	A5	change	-4.55 kg	-5.73 to -3.37	3	not stated; other; group:cohort_30_mg; R0007796:Supplement Table S7
3.86	A5	change	-3.04 kg	-5.00 to -1.08	3	not stated; other; group:cohort_5_mg; R0007796:Supplement Table S7
3.86	A5	change	-3.02 kg	-5.98 to -0.05	3	not stated; other; group:cohort_50_mg; R0007796:Supplement Table S7

Percent body weight change (8 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
3.86	A1	percent change	-3.28 percent	-4.37 to -2.18	9	not stated; other; R0007796:Supplement Table S7
3.86	A2	percent change	-3.61 percent	-4.96 to -2.26	9	not stated; other; R0007796:Supplement Table S7
3.86	A3	percent change	-4.90 percent	-5.709 to -4.11	9	not stated; other; R0007796:Supplement Table S7
3.86	A4	percent change	-5.76 percent	-7.43 to -4.09	9	not stated; other; R0007796:Supplement Table S7
3.86	A5	percent change	-7.02 percent	-9.37 to -4.67	3	not stated; other; group:cohort_10_mg; R0007796:Supplement Table S7
3.86	A5	percent change	-5.31 percent	-6.69 to -3.92	3	not stated; other; group:cohort_30_mg; R0007796:Supplement Table S7
3.86	A5	percent change	-3.32 percent	-5.47 to -1.17	3	not stated; other; group:cohort_5_mg; R0007796:Supplement Table S7
3.86	A5	percent change	-3.52 percent	-7.01 to -0.03	3	not stated; other; group:cohort_50_mg; R0007796:Supplement Table S7

All cause mortality (5 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0007796:Table 2
A2	events	0 / 9	not stated; safety; R0007796:Table 2
A3	events	0 / 10	not stated; safety; R0007796:Table 2
A4	events	0 / 10	not stated; safety; R0007796:Table 2
A5	events	0 / 13	not stated; safety; R0007796:Table 2

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0007796:Table 2
A2	events	0 / 9	not stated; safety; R0007796:Table 2
A3	events	0 / 10	not stated; safety; R0007796:Table 2
A4	events	0 / 10	not stated; safety; R0007796:Table 2
A5	events	0 / 13	not stated; safety; R0007796:Table 2

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0007796:Table 2
A2	events	0 / 9	not stated; safety; R0007796:Table 2
A3	events	1 / 10	not stated; safety; R0007796:Table 2
A4	events	1 / 10	not stated; safety; R0007796:Table 2
A5	events	0 / 13	not stated; safety; R0007796:Table 2

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 9	not stated; safety; R0007796:Table 2
A2	events	1 / 9	not stated; safety; R0007796:Table 2
A3	events	6 / 10	not stated; safety; R0007796:Table 2
A4	events	6 / 10	not stated; safety; R0007796:Table 2
A5	events	1 / 13	not stated; safety; R0007796:Table 2

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0007796:Table 2
A2	events	0 / 9	not stated; safety; R0007796:Table 2
A3	events	1 / 10	not stated; safety; R0007796:Table 2
A4	events	2 / 10	not stated; safety; R0007796:Table 2
A5	events	0 / 13	not stated; safety; R0007796:Table 2

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 9	not stated; safety; R0007796:Table 2
A2	events	0 / 9	not stated; safety; R0007796:Table 2
A3	events	2 / 10	not stated; safety; R0007796:Table 2
A4	events	2 / 10	not stated; safety; R0007796:Table 2
A5	events	3 / 13	not stated; safety; R0007796:Table 2

Constipation (5 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0007796:Table 2
A2	events	2 / 9	not stated; safety; R0007796:Table 2
A3	events	7 / 10	not stated; safety; R0007796:Table 2
A4	events	2 / 10	not stated; safety; R0007796:Table 2
A5	events	3 / 13	not stated; safety; R0007796:Table 2