Trial reportBritish journal of clinical pharmacology2010
Influence of hepatic impairment on pharmacokinetics of the human GLP-1 analogue, liraglutide.
Trial report in British journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- Pooled it
- Pooled it
- Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment.Journal of clinical pharmacology · 2018 · on this mapTrial
- Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment.Diabetes, obesity & metabolism · 2018 · on this mapTrial
- Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus.Clinical pharmacokinetics · 2016 · on this mapTrial
- Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide.British journal of clinical pharmacology · 2009 · on this mapTrial
- Pharmacokinetics, safety, and tolerability of fedratinib in adults with moderate and severe hepatic impairment: results from the phase 1 FEDR-CP-001 trial.Cancer chemotherapy and pharmacology · 2025Article
- Targeted Therapy Evolution from Defining a Sub-population to Crossing Multi-indications.Advanced pharmaceutical bulletin · 2024Article
- Potential Role of Phytochemicals as Glucagon-like Peptide 1 Receptor (GLP-1R) Agonists in the Treatment of Diabetes Mellitus.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Impact of Sex and Gender on Clinical Management of Patients with Advanced Chronic Liver Disease and Type 2 Diabetes.Journal of personalized medicine · 2023Review
- Management and Risks Before, During, and After Liver Transplant in Individuals With Obesity.Gastroenterology & hepatology · 2023Article
- Review
- Population Pharmacokinetics of Cotadutide in Subjects with Type 2 Diabetes.Clinical pharmacokinetics · 2022Article
- Impact of Intrinsic and Extrinsic Factors on the Pharmacokinetics of Peptides: When Is the Assessment of Certain Factors Warranted?Antibodies (Basel, Switzerland) · 2021Review
- Clinical Impact of Liraglutide as a Treatment of Obesity.Clinical pharmacology : advances and applications · 2021Review
- Inventing Liraglutide, a Glucagon-Like Peptide-1 Analogue, for the Treatment of Diabetes and Obesity.ACS pharmacology & translational science · 2019Article
- Consensus Recommendations on GLP-1 RA Use in the Management of Type 2 Diabetes Mellitus: South Asian Task Force.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Review
- A review of lipidation in the development of advanced protein and peptide therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2019Review
- Clinical potential of liraglutide in cardiovascular risk reduction in patients with type 2 diabetes: evidence to date.Diabetes, metabolic syndrome and obesity : targets and therapy · 2019Review
- The Discovery and Development of Liraglutide and Semaglutide.Frontiers in endocrinology · 2019 · on this mapReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo compare the pharmacokinetics (PK) of a single-dose of liraglutide in subjects with hepatic impairment.
methodsThis parallel group, open label trial involved four groups of six subjects with healthy, mild, moderate and severe hepatic impairment, respectively. Each subject received 0.75 mg of liraglutide (s.c., thigh), and blood samples were taken over 72 h for PK assessment. Standard laboratory and safety data were collected. The primary endpoint was area under the plasma liraglutide concentration-time curve from time zero to infinity (AUC(0,∞)).
resultsExposure to liraglutide was not increased by hepatic impairment. On the contrary, mean AUC(0,∞) was highest for healthy subjects and lowest for subjects with severe hepatic impairment (severe/healthy: 0.56, with 90% CI 0.39, 0.81) and equivalence in this parameter across groups was not demonstrated. C(max) also tended to decrease with hepatic impairment (severe/healthy: 0.71, with 90% CI 0.52, 0.97), but t(max) was similar across groups (11.3-13.2 h). There were no serious adverse events, hypoglycaemic episodes or clinically significant changes in laboratory parameters and liraglutide was considered well tolerated.
conclusionsThis study indicated no safety concerns regarding use of liraglutide in patients with hepatic impairment. Exposure to liraglutide was not increased by impaired liver function; rather, the results suggest a decreased exposure with increasing degree of hepatic impairment. However, data are not conclusive to suggest a dose increase of liraglutide. Thus, the results indicate that patients with type 2 diabetes mellitus and hepatic impairment can use standard treatment regimens of liraglutide. There is, however, currently limited clinical experience with liraglutide in patients with hepatic impairment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.