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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Hepatic Impaired; Diabetes Mellitus, Type 2

Treatments: Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02210871

NN9535-3651

U1111-1149-3924 (Other Identifier)

2009-011673-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

Normal hepatic function

Experimental group

Treatment:

Drug: semaglutide

Mild hepatic impairment

Experimental group

Treatment:

Drug: semaglutide

Moderate hepatic impairment

Experimental group

Treatment:

Drug: semaglutide

Severe hepatic impairment

Experimental group

Treatment:

Drug: semaglutide