Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02016911

U1111-1139-1272 (Other Identifier)

2013-000550-21 (EudraCT Number)

NN9924-4082

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.

Enrollment: 56 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
• Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)

Exclusion criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
• History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
• Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
• Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
• History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Subjects with hepatic impairment

Experimental group

Treatment:

Drug: semaglutide

Subjects with normal hepatic function

Active Comparator group

Treatment:

Drug: semaglutide