Study S000203

A Non-randomised, Open-label, 2-part, Parallel-cohort Trial to Evaluate 1) Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of BI 456906 in Patients With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Healthy Subjects With and Without Overweight/Obesity and 2) Safety and Tolerability of Multiple Subcutaneous Doses of BI 456906 in Patients With Overweight/Obesity With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Patients With Overweight/Obesity Without Cirrhosis/Hepatic Impairment

ClinicalTrials.gov record

Registration

Registration: NCT05296733
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 82
Start: 2022-04-27
Primary completion: 2023-12-29
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy; Liver Diseases; Obesity
Interventions: DRUG:BI 456906
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: EUDRACT_NUMBER:2021-006247-10

Registered primary outcomes

Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [Up to 360 hours]
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax) [Up to 360 hours]
Part B: Percentage of patients treated who experience treatment-emergent adverse event [Up to Day 218]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0016538	Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis. Lawitz EJ, Journal of hepatology	2024	Randomized trial	PMID 38857788 DOI	cites ClinicalTrials.gov:NCT05296733; registry reference DERIVED:38857788