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Trial · Interventional

CompletedPhase 1Registry data

Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

NCTNCT02210871 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3651Other idU1111-1149-3924Other id2009-011673-33Other id2009

Overview

Status
Completed
Phase
Phase 1
Enrollment
44 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

Poland, Slovakia

Start
7 Aug 2014
Primary completion
3 Jun 2015
Completion
3 Jun 2015
First posted
7 Aug 2014 (estimated)
Last update posted
21 Dec 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Hepatic Impaired

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

    NCT02210871

    7 Aug 2014 to 3 Jun 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild, moderate or severe hepatic impairment compared to subjects with normal hepatic function.

Interventions

  • semaglutideDrug

Arms4

  • Experimental

    Normal hepatic function

  • Experimental

    Mild hepatic impairment

  • Experimental

    Moderate hepatic impairment

  • Experimental

    Severe hepatic impairment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the semaglutide plasma concentration-time curve

    Time frame · Day 1 - day 36

Secondary outcomes(2)
  1. Maximum observed semaglutide plasma concentration

    Time frame · Day 1 - day 36

  2. Number of treatment emergent adverse events (TEAEs)

    Time frame · Day 1 - day 36

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2018

3 results

Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment.

Jensen et al. 2018Diabetes, obesity & metabolismcited by 58

PMID 29205786PMC5873441DOI 10.1111/dom.13186PUB-29205786

Free to read · publisher termsCC BY-NC-ND3 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, age at least 18 years at the time of signing informed consent * Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive) * Only for subjects with hepatic impairment (mild, moderate and severe): A diagnosis of cirrhosis due to parenchymal liver disease, classified as Child-Pugh grade A,B or C as assessed by investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound,computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy * Only for subjects with normal hepatic function: Subjects who are judged to be in good general health based on physical examination, medical history, ECG, vital signs, and the results of biochemistry, coagulation, haematology tests and urinalysis performed during the screening visit, as judged by the investigator Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including the follow-up period (adequate contraceptive measures as required by local regulation or practice) * Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement at the screening visit is allowed * Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures * Donation of any blood or plasma in the past month or in excess of 400 mL within the 3 months preceding screening, or surgery or trauma with more than 400 mL blood loss within the 3 months preceding screening

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