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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2017-12-21
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
Interventions
- DRUG
-
All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry GCR, 1452 · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-07
- Primary Completion
- 2015-06-03
- Completion
- 2015-06-03
Countries
- Poland
- Slovakia
Study Locations
More Related Trials
-
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects
NCT02161588 ·Status: COMPLETED ·Phase: PHASE1
-
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets
NCT04109508 ·Status: COMPLETED ·Phase: PHASE1
-
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
NCT04822181 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.
NCT02920385 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
NCT03288740 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
NCT00696657 ·Status: COMPLETED ·Phase: PHASE2
-
Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
NCT02249871 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
NCT02453711 ·Status: COMPLETED ·Phase: PHASE2
-
A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
NCT04187300 ·Status: COMPLETED ·Phase: PHASE1
-
Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People
NCT04524832 ·Status: COMPLETED ·Phase: PHASE1
-
Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo
NCT02079870 ·Status: COMPLETED ·Phase: PHASE1
-
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
NCT05649137 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens
NCT04152915 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
NCT05232708 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects
NCT01572753 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
NCT01766245 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
NCT02692716 ·Status: COMPLETED ·Phase: PHASE3
-
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
NCT01923181 ·Status: COMPLETED ·Phase: PHASE2
-
A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage
NCT03987451 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes
NCT01507311 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity
NCT04007107 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
NCT07302802 ·Status: RECRUITING
-
Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc
NCT04189848 ·Status: COMPLETED ·Phase: PHASE4
-
A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
NCT03598621 ·Status: COMPLETED ·Phase: PHASE1
-
Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
NCT05040971 ·Status: COMPLETED ·Phase: PHASE3