parallel randomized trial

NCT03288740

A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Other conditions NCT03288740S000680

Design

Randomized: 36
Start year: 2017
Treatment: 13 weeks, follow-up 18 weeks
Countries: China (1 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: healthy Chinese adults 18 to 55 years; BMI 20.0 to 24.9; weight 54 kg or more

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized
A1	Semaglutide 0.5 mg subcutaneous once weekly Semaglutide 0.5 mg	lifestyle: none	12
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg	lifestyle: none	12
A3	Placebo Placebo (pooled 0.5 and 1.0 mg volumes)	lifestyle: none	12

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 0.5 mg subcutaneous once weekly A1	Semaglutide 1.0 mg subcutaneous once weekly A2	Placebo A3
age	max (years)	44	44	52
age	mean (years)	33.6	33.3	33.3
age	min (years)	23	22	27
bmi	max (kg/m2)	24.2	24.2	24.3
bmi	mean (kg/m2)	22.6	22.8	22.5
bmi	min (kg/m2)	21.0	20.3	20.5
female	n	5	5	5
female	percent	41.7	41.7	41.7
weight	max (kg)	75.0	79.9	68.0
weight	mean (kg)	64.8	63.0	63.4
weight	min (kg)	58.7	55.1	57.4

Results

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

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; R0016699:Table 3
A2	events	0 / 12	not stated; safety; R0016699:Table 3
A3	events	1 / 12	not stated; safety; R0016699:Table 3

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; R0016699:Table 3
A2	events	0 / 12	not stated; safety; R0016699:Table 3
A3	events	1 / 12	not stated; safety; R0016699:Table 3

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; R0016699:Discussion
A2	events	0 / 12	not stated; safety; R0016699:Discussion
A3	events	0 / 12	not stated; safety; R0016699:Discussion