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

NCT ID: NCT02210871

Last Updated: 2017-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-07
• Study Completion Date: 2015-06-03

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Hepatic Impaired

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal hepatic function

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

Mild hepatic impairment

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

Moderate hepatic impairment

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

Severe hepatic impairment

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

Interventions

semaglutide

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry GCR, 1452

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Warsaw, , Poland

Novo Nordisk Investigational Site

Wołomin, , Poland

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Countries

Poland; Slovakia

References

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.

Reference Type: RESULT

PMID: 29205786 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1149-3924

Identifier Type: OTHER

Identifier Source: secondary_id

2009-011673-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9535-3651

Identifier Type: -

Identifier Source: org_study_id