NCT02210871

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Aug 2014

Typical duration for phase_1 diabetes

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2015

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

August 6, 2014

Last Update Submit

December 20, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2Hepatic Impaired

Outcome Measures

Primary Outcomes (1)

  • Area under the semaglutide plasma concentration-time curve

    Day 1 - day 36

Secondary Outcomes (2)

  • Maximum observed semaglutide plasma concentration

    Day 1 - day 36

  • Number of treatment emergent adverse events (TEAEs)

    Day 1 - day 36

Study Arms (4)

Normal hepatic function

EXPERIMENTAL
Drug: semaglutide

Mild hepatic impairment

EXPERIMENTAL
Drug: semaglutide

Moderate hepatic impairment

EXPERIMENTAL
Drug: semaglutide

Severe hepatic impairment

EXPERIMENTAL
Drug: semaglutide

Interventions

semaglutideDRUG

All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.

Mild hepatic impairmentModerate hepatic impairmentNormal hepatic functionSevere hepatic impairment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novo Nordisk Investigational Site

Warsaw, 02-507, Poland

Location

Novo Nordisk Investigational Site

Wołomin, 05-200, Poland

Location

Novo Nordisk Investigational Site

Bratislava, 83101, Slovakia

Location

Novo Nordisk Investigational Site

Bratislava, 833 05, Slovakia

Location

Related Publications (1)

  • Jensen L, Kupcova V, Arold G, Pettersson J, Hjerpsted JB. Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment. Diabetes Obes Metab. 2018 Apr;20(4):998-1005. doi: 10.1111/dom.13186. Epub 2018 Jan 17.

    PMID: 29205786RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry GCR, 1452

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 7, 2014

Study Start

August 7, 2014

Primary Completion

June 3, 2015

Study Completion

June 3, 2015

Last Updated

December 21, 2017

Record last verified: 2017-12

Locations

SL(2)PL(2)