parallel randomized trial

NCT02075281

A 20-week, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Safety and Efficacy of HM11260C on Body Weight in Obese Subjects Without Diabetes

Overweight or obesity without diabetes (adults)NCT02075281S000743

Design

Randomized: 297
Start year: 2014
Treatment: 20 weeks, follow-up 26 weeks
Countries: Germany, Hungary, Netherlands, Republic of Korea, United States
Sponsor: Hanmi Pharmaceutical (industry)
Eligibility: age 18 to 64 years; BMI 30 to 42, or 27 to 30 with comorbidity; FPG below 7 mmol/L; HbA1c 6.5 percent or less; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	lifestyle: standard	60	60	48
A2	Efpeglenatide 4 mg subcutaneous once weekly Efpeglenatide 4 mg once weekly	lifestyle: standard	59	59
A3	Efpeglenatide 6 mg subcutaneous once weekly Efpeglenatide 6 mg once weekly	lifestyle: standard	59	59
A4	Efpeglenatide 6 mg injection every 2 weeks Efpeglenatide 6 mg once every 2 weeks	lifestyle: standard	59	59
A5	Efpeglenatide 8 mg injection every 2 weeks Efpeglenatide 8 mg once every 2 weeks	lifestyle: standard	60	58

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Efpeglenatide 4 mg subcutaneous once weekly A2	Efpeglenatide 6 mg subcutaneous once weekly A3	Efpeglenatide 6 mg injection every 2 weeks A4	Efpeglenatide 8 mg injection every 2 weeks A5
age	mean (years)	43.7	42.9	43.0	43.3	43.9
age	sd (years)	11.8	12.1	13.0	12.5	9.2
asian	n	3	4	8	5	5
asian	percent	5.0	6.8	13.6	8.5	8.6
black	n	16	12	11	8	13
black	percent	26.7	20.3	18.6	13.6	22.4
bmi: 27 to less than 30	n	2	5	3	2	3
bmi: 27 to less than 30	percent	3.3	8.5	5.1	3.4	5.2
bmi: 30 or more	n	58	54	56	57	55
bmi: 30 or more	percent	96.7	91.5	94.9	96.6	94.8
bmi	mean (kg/m2)	34.9	35.2	36.3	35.6	35.2
bmi	sd (kg/m2)	3.2	4.5	4.4	4.8	3.9
female	n	44	41	46	43	51
female	percent	73.3	69.5	78.0	72.9	87.9
hba1c	mean (percent)	5.5	5.5	5.4	5.5	5.4
hba1c	sd (percent)	0.4	0.4	0.4	0.3	0.4
hispanic	n	7	4	10	7	6
hispanic	percent	11.7	6.8	16.9	11.9	10.3
other race american indian alaska native	n	1	0	0	0	0
other race american indian alaska native	percent	1.7	0	0	0	0
other race multiple	n	0	1	1	0	0
other race multiple	percent	0	1.7	1.7	0	0
other race native hawaiian pacific islander	n	0	1	0	0	1
other race native hawaiian pacific islander	percent	0	1.7	0	0	1.7
other race other	n	1	0	2	1	0
other race other	percent	1.7	0	3.4	1.7	0
sbp	mean (mmHg)	124.2	120.5	119.8	121.4	121.8
sbp	sd (mmHg)	12.8	10.4	9.3	10.8	10.8
waist	mean (cm)	109.3	109.8	111.9	109.6	108.9
waist	sd (cm)	10.7	12.2	13.3	11.8	10.9
weight	mean (kg)	97.5	100.8	101.7	99.5	95.6
weight	sd (kg)	12.1	19.3	19.4	18.4	13.3
white	n	39	41	37	45	39
white	percent	65.0	69.5	62.7	76.3	67.2

Analyses this trial contributes to

Results

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

Systolic blood pressure change (9 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	change	-0.1 mmHg	1.3		48	not stated; safety; R0011218:Supplement Table S7
20	A2	change	-3.5 mmHg	1.4		44	not stated; safety; R0011218:Supplement Table S7
20	A2 vs A1	md	-3.4 mmHg		-7.2 to 0.4		not stated; safety; R0011218:Supplement Table S7
20	A3	change	-6.1 mmHg	1.4		42	not stated; safety; R0011218:Supplement Table S7
20	A3 vs A1	md	-6.0 mmHg		-9.8 to -2.2		not stated; safety; R0011218:Supplement Table S7
20	A4	change	-0.3 mmHg	1.4		41	not stated; safety; R0011218:Supplement Table S7
20	A4 vs A1	md	-0.2 mmHg		-4.0 to 3.6		not stated; safety; R0011218:Supplement Table S7
20	A5	change	-3.0 mmHg	1.4		40	not stated; safety; R0011218:Supplement Table S7
20	A5 vs A1	md	-2.9 mmHg		-6.8 to 0.9		not stated; safety; R0011218:Supplement Table S7

Percent body weight change (9 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Detail
20	A1	percent change	0.1 percent	0.6		not stated; full analysis; R0011218:Table 2
20	A2	percent change	-6.7 percent	0.6		not stated; full analysis; R0011218:Table 2
20	A2 vs A1	md	-6.8 percent		-8.4 to -5.1	not stated; full analysis; R0011218:Table 2
20	A3	percent change	-7.3 percent	0.6		not stated; full analysis; R0011218:Table 2
20	A3 vs A1	md	-7.4 percent		-9.1 to -5.7	not stated; full analysis; R0011218:Table 2
20	A4	percent change	-6.7 percent	0.6		not stated; full analysis; R0011218:Table 2
20	A4 vs A1	md	-6.7 percent		-8.4 to -5.1	not stated; full analysis; R0011218:Table 2
20	A5	percent change	-7.4 percent	0.6		not stated; full analysis; R0011218:Table 2
20	A5 vs A1	md	-7.5 percent		-9.2 to -5.8	not stated; full analysis; R0011218:Table 2

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

Week	Arm	Statistic	Events / N	Detail
20	A1	responders	2 / 60	not stated; full analysis; R0011218:Figure 1
20	A2	responders	28 / 59	not stated; full analysis; R0011218:Figure 1
20	A3	responders	30 / 59	not stated; full analysis; R0011218:Figure 1
20	A4	responders	27 / 59	not stated; full analysis; R0011218:Figure 1
20	A5	responders	31 / 58	not stated; full analysis; R0011218:Figure 1

Weight loss of 10 percent or more (5 lines; O11B)

Week	Arm	Statistic	Events / N	Detail
20	A1	responders	1 / 60	not stated; full analysis; R0011218:Figure 1
20	A2	responders	11 / 59	not stated; full analysis; R0011218:Figure 1
20	A3	responders	16 / 59	not stated; full analysis; R0011218:Figure 1
20	A4	responders	12 / 59	not stated; full analysis; R0011218:Figure 1
20	A5	responders	11 / 58	not stated; full analysis; R0011218:Figure 1

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				1 / 59	not stated; safety; acute renal failure; R0011218:Results

All cause mortality (5 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; randomized; R0011218:Figure S2
A2	events	0 / 59	not stated; randomized; R0011218:Figure S2
A3	events	0 / 59	not stated; randomized; R0011218:Figure S2
A4	events	0 / 59	not stated; randomized; R0011218:Figure S2
A5	events	0 / 60	not stated; randomized; R0011218:Figure S2

Three point MACE (5 lines; O21)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Results
A2	events	0 / 59	not stated; safety; R0011218:Results
A3	events	0 / 59	not stated; safety; R0011218:Results
A4	events	0 / 59	not stated; safety; R0011218:Results
A5	events	0 / 58	not stated; safety; R0011218:Results

Four point MACE including unstable angina (5 lines; O21B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Results
A2	events	0 / 59	not stated; safety; R0011218:Results
A3	events	0 / 59	not stated; safety; R0011218:Results
A4	events	0 / 59	not stated; safety; R0011218:Results
A5	events	0 / 58	not stated; safety; R0011218:Results

Hospitalization for heart failure (5 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Results
A2	events	0 / 59	not stated; safety; R0011218:Results
A3	events	0 / 59	not stated; safety; R0011218:Results
A4	events	0 / 59	not stated; safety; R0011218:Results
A5	events	0 / 58	not stated; safety; R0011218:Results

Heart failure events (5 lines; O23B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Results
A2	events	0 / 59	not stated; safety; R0011218:Results
A3	events	0 / 59	not stated; safety; R0011218:Results
A4	events	0 / 59	not stated; safety; R0011218:Results
A5	events	0 / 58	not stated; safety; R0011218:Results

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Table 3
A2	events	1 / 59	not stated; safety; R0011218:Table 3
A3	events	3 / 59	not stated; safety; R0011218:Table 3
A4	events	0 / 59	not stated; safety; R0011218:Table 3
A5	events	2 / 58	not stated; safety; R0011218:Table 3

Discontinuation due to adverse events (10 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 60	not stated; randomized; R0011218:Figure S2
A1	events	4 / 60	not stated; safety; R0011218:Table 3
A2	events	3 / 59	not stated; randomized; R0011218:Figure S2
A2	events	3 / 59	not stated; safety; R0011218:Table 3
A3	events	11 / 59	not stated; randomized; R0011218:Figure S2
A3	events	11 / 59	not stated; safety; R0011218:Table 3
A4	events	7 / 59	not stated; safety; R0011218:Table 3
A4	events	7 / 59	not stated; randomized; R0011218:Figure S2
A5	events	10 / 58	not stated; safety; R0011218:Table 3
A5	events	11 / 60	not stated; randomized; R0011218:Figure S2

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	11 / 60	not stated; safety; R0011218:Table 3
A2	events	32 / 59	not stated; safety; R0011218:Table 3
A3	events	35 / 59	not stated; safety; R0011218:Table 3
A4	events	28 / 59	not stated; safety; R0011218:Table 3
A5	events	36 / 58	not stated; safety; R0011218:Table 3

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	4 / 60	not stated; safety; R0011218:Table 3
A2	events	13 / 59	not stated; safety; R0011218:Table 3
A3	events	13 / 59	not stated; safety; R0011218:Table 3
A4	events	10 / 59	not stated; safety; R0011218:Table 3
A5	events	19 / 58	not stated; safety; R0011218:Table 3

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	12 / 60	not stated; safety; R0011218:Table 3
A2	events	14 / 59	not stated; safety; R0011218:Table 3
A3	events	12 / 59	not stated; safety; R0011218:Table 3
A4	events	15 / 59	not stated; safety; R0011218:Table 3
A5	events	16 / 58	not stated; safety; R0011218:Table 3

Constipation (5 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	5 / 60	not stated; safety; R0011218:Table 3
A2	events	10 / 59	not stated; safety; R0011218:Table 3
A3	events	12 / 59	not stated; safety; R0011218:Table 3
A4	events	9 / 59	not stated; safety; R0011218:Table 3
A5	events	12 / 58	not stated; safety; R0011218:Table 3

Discontinuation due to gastrointestinal adverse events (5 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	1 / 60	not stated; safety; R0011218:Supplement Table S6
A2	events	2 / 59	not stated; safety; R0011218:Supplement Table S6
A3	events	9 / 59	not stated; safety; R0011218:Supplement Table S6
A4	events	4 / 59	not stated; safety; R0011218:Supplement Table S6
A5	events	8 / 58	not stated; safety; R0011218:Supplement Table S6

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A5	events				1 / 58	not stated; safety; cholecystitis; R0011218:Results
	A5	events				1 / 58	not stated; safety; cholelithiasis; R0011218:Results

Acute pancreatitis (5 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Results
A2	events	0 / 59	not stated; safety; R0011218:Results
A3	events	0 / 59	not stated; safety; R0011218:Results
A4	events	0 / 59	not stated; safety; R0011218:Results
A5	events	0 / 58	not stated; safety; R0011218:Results

Medullary thyroid carcinoma (5 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Results
A2	events	0 / 59	not stated; safety; R0011218:Results
A3	events	0 / 59	not stated; safety; R0011218:Results
A4	events	0 / 59	not stated; safety; R0011218:Results
A5	events	0 / 58	not stated; safety; R0011218:Results

Thyroid cancer (any) (5 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; safety; R0011218:Results
A2	events	0 / 59	not stated; safety; R0011218:Results
A3	events	0 / 59	not stated; safety; R0011218:Results
A4	events	0 / 59	not stated; safety; R0011218:Results
A5	events	0 / 58	not stated; safety; R0011218:Results

Death by suicide (5 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 60	not stated; randomized; R0011218:Figure S2
A2	events	0 / 59	not stated; randomized; R0011218:Figure S2
A3	events	0 / 59	not stated; randomized; R0011218:Figure S2
A4	events	0 / 59	not stated; randomized; R0011218:Figure S2
A5	events	0 / 60	not stated; randomized; R0011218:Figure S2