Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial.

Shi A, Xie P, Nielsen LL, Skjøth TV, He X, Haugaard SP

Advances in therapy7 Nov 2020Cited by 22 (Europe PMC)

PMID33159658PMCIDPMC7854449DOI10.1007/s12325-020-01548-yPepBankPUB-33159658

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, once-weekly semaglutide 0.5 mg gave a steady-state AUC of 4000 nmol h/l and a Cmax of 28.8 nmol/l.
In plain wordsIn healthy Chinese subjects, weekly semaglutide 0.5 mg reached a stable blood level shown by these exposure values.
Peptide
Semaglutide
Outcome
Not applicableSteady-state exposure, semaglutide 0.5 mg
Study
n: not reported in source
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.5 mg once weekly · subcutaneousAs given in this study (human).
Measurements
AUC0-168h,ss
4000 nmol h/l
semaglutide 0.5 mg
Cmax,ss
28.8 nmol/l
semaglutide 0.5 mg
Source sentences
Summary
The steady-state exposure of semaglutide was higher for subjects treated with 1.0 mg semaglutide (AUC_0-168 h,ss: 7961 nmol h/l and C_max,ss: 55.9 nmol/l) compared to 0.5 mg semaglutide (AUC_0-168 h,ss: 4000 nmol h/l and C_max,ss: 28.8 nmol/l).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC_0-168 h,SS).
Summary · context
In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12).
Report a problemFND-3315965801
02HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, once-weekly semaglutide 1.0 mg gave a steady-state AUC of 7961 nmol h/l and a Cmax of 55.9 nmol/l.
In plain wordsIn healthy Chinese subjects, weekly semaglutide 1.0 mg reached a stable blood level higher than with 0.5 mg.
Peptide
Semaglutide
Outcome
Not applicableSteady-state exposure, semaglutide 1.0 mg
Study
n: not reported in source
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
AUC0-168h,ss
7961 nmol h/l
semaglutide 1.0 mg
Cmax,ss
55.9 nmol/l
semaglutide 1.0 mg
Source sentences
Summary
The steady-state exposure of semaglutide was higher for subjects treated with 1.0 mg semaglutide (AUC_0-168 h,ss: 7961 nmol h/l and C_max,ss: 55.9 nmol/l) compared to 0.5 mg semaglutide (AUC_0-168 h,ss: 4000 nmol h/l and C_max,ss: 28.8 nmol/l).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC_0-168 h,SS).
Summary · context
In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12).
Report a problemFND-3315965802
03HumanRandomized controlled trialSafety outcome
In healthy Chinese subjects, once-weekly subcutaneous semaglutide was well tolerated.
In plain wordsIn healthy Chinese subjects, weekly semaglutide was well tolerated.
Peptide
Semaglutide
Outcome
No significant changeTolerability
Study
n = 36
Comparator
Placebo
Outcome group
Adverse events · Pharmacology
Studied dose
0.5 mg or 1.0 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Treatment with OW s.c. semaglutide was well tolerated in healthy Chinese subjects.
1 context sentence(design, population, supporting numbers)
Summary · context
In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12).
Report a problemFND-3315965804
04HumanRandomized controlled trialSafety outcome
In healthy Chinese subjects, the most common adverse events with semaglutide were gastrointestinal, and no new safety signals were identified.
In plain wordsIn healthy Chinese subjects, the most common side effects of semaglutide were in the gut, and no new safety signals appeared.
Peptide
Semaglutide
Outcome
Direction not reportedGastrointestinal adverse events
Study
n = 36
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg or 1.0 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
As expected for the GLP-1 receptor agonist class, the most common adverse events were gastrointestinal, and no new safety signals were identified.
1 context sentence(design, population, supporting numbers)
Summary · context
In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12).
Report a problemFND-3315965805
05HumanRandomized controlled trialPharmacokinetics
In healthy Chinese subjects, semaglutide total exposure rose dose-proportionally, with a 1.0 mg/0.5 mg AUC treatment ratio of 1.99.
In plain wordsIn healthy Chinese subjects, doubling the semaglutide dose about doubled the blood exposure.
Peptide
Semaglutide
Outcome
Not applicableDose proportionality of AUC (1.0 mg / 0.5 mg)
Study
n: not reported in source
Comparator
Semaglutide 0.5 mg
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.5 mg and 1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
AUC treatment ratio (1.0 mg/0.5 mg)
1.99 ratio
healthy Chinese subjects
Source sentences
Summary
The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg) [95% confidence interval] for AUC_0-168 h,SS was 1.99 [1.78; 2.23].
1 context sentence(design, population, supporting numbers)
Summary · context
In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12).
Report a problemFND-3315965803

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT03288740

A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Novo Nordisk A/Sn = 3621 Sept 2017 to 7 Aug 2018

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 15 Feb 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

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