NCT05661344

A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems

Completed Phase 1 Results posted Last updated 28 November 2025

What this trial tests

Phase 1 trial testing BI 1015550 in Hepatic Insufficiency in 28 participants. Completed in 13 September 2023.

Timeline

7 February 2023

Primary endpoint
13 September 2023

13 September 2023

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	7 February 2023
Primary completion	13 September 2023
Estimated completion	13 September 2023
Sites	1 location across Germany

Drugs / interventions tested

• BI 1015550 — full drug profile →

Conditions studied

• Hepatic Insufficiency — all drugs for Hepatic Insufficiency →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 79, any sex, with Hepatic Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Primary · Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration.

Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as

Group	Value	95% CI
BI 1015550 mild hepatic impairment	2913.55	± NA
BI 1015550 moderate hepatic impairment	2837.74	± NA
BI 1015550 normal hepatic function matched to mild hepatic impairment	2786.43	± NA
BI 1015550 normal hepatic function matched to moderate hepatic impairment	2168.11	± NA

Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax) Primary · Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration.

Maximum measured concentration of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then

Group	Value	95% CI
BI 1015550 mild hepatic impairment	409.35	± NA
BI 1015550 moderate hepatic impairment	277.67	± NA
BI 1015550 normal hepatic function matched to mild hepatic impairment	491.48	± NA
BI 1015550 normal hepatic function matched to moderate hepatic impairment	404.46	± NA

Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Secondary · Within the 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 and 144 hours after drug administration.

Area under the concentration-time curve of R-BI 1015550 (the pharmacologically active enantiomer, determined using the chiral bioanalytical assay) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effe

Group	Value	95% CI
BI 1015550 mild hepatic impairment	2964.46	± NA
BI 1015550 moderate hepatic impairment	2866.58	± NA
BI 1015550 normal hepatic function matched to mild hepatic impairment	2811.48	± NA
BI 1015550 normal hepatic function matched to moderate hepatic impairment	2186.53	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From the administration of BI 1015550, until the end of the on-treatment period, up to 7 days. All-cause mortality was recorded from the administration of BI 1015550 until the end of trial, up to 2 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 1015550 normal hepatic function matched to mild hepatic impairment

Serious: 0/8 (0%)

Deaths: 0/8

BI 1015550 mild hepatic impairment

Serious: 0/8 (0%)

Deaths: 0/8

BI 1015550 normal hepatic function matched to moderate hepatic impairment

Serious: 0/8 (0%)

Deaths: 0/8

BI 1015550 moderate hepatic impairment

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (5 terms — click to expand)

Reaction	System	BI 1015550 normal hepatic …	BI 1015550 mild hepatic im…	BI 1015550 normal hepatic …	BI 1015550 moderate hepati…
Headache	Nervous system disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Catheter site inflammation	General disorders	—	—	—	—
Subcutaneous haematoma	Injury, poisoning and procedural complications	—	—	—	—
Lipase increased	Investigations	—	—	—	—

Data from ClinicalTrials.gov NCT05661344 adverse events section.

Sponsor's own description

This study is open to adults aged 18 years and older. People without liver problems and people who have mild or moderate liver problems can join the study.

The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the blood of people with and without liver problems. Liver problems may change how a medicine is processed in the body.

Participants are in the study for about 2 weeks. During this time, they visit the study site 6 times. On the second visit, participants stay overnight at the study site for 4 nights. At the visits, doctors take blood samples to measure the levels of BI 1015550 in participants' blood. Then they compare the results between the groups of participants with and without liver problems. The doctors also check participants' health and take note of any unwanted effects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.