Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug
CompletedPhase 2Results postedLast updated 3 July 2023
What this trial tests
Phase 2 trial testing Fesomersen sodium (BAY2976217) in End Stage Renal Disease Requiring Hemodialysis in 307 participants. Completed in 12 May 2022.
18 and older, any sex, with End Stage Renal Disease Requiring Hemodialysis. 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.
Incidence of Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) During the Main Treatment Period and Within the On-treatment Time Window, as Assessed by Blinded Central Independent Adjudication Committee (CIAC)Primary· Up to 24 weeks
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following cri
Group
Value
95% CI
Fesomersen 40 mg
9.0
2.5 – 18.9
Fesomersen 80 mg
9.1
2.5 – 19.1
Fesomersen 120 mg
6.1
1.1 – 14.5
Placebo
9.7
2.7 – 20.4
Incidence of Composite of MB and CRNMB During the Main and Extended Treatment Periods and Within the On-treatment Time Window, as Assessed by Blinded CIACSecondary· Up to 48 weeks
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following cri
Group
Value
95% CI
Fesomersen 40 mg
10.7
4.2 – 19.7
Fesomersen 80 mg
8.6
2.9 – 16.7
Fesomersen 120 mg
6.4
1.7 – 13.3
Placebo
7.0
1.9 – 14.8
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Main Treatment Period and Within the On-treatment Time Window and Their SeveritySecondary· Up to 24 weeks
TEAEs were analyzed during the on-treatment time window within the main treatment period in the safety analysis set (SAF). Data observed from the randomization date until the end of the main treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
Any TEAE
Group
Value
95% CI
Fesomersen 40 mg
54
Fesomersen 80 mg
56
Fesomersen 120 mg
55
Placebo
55
Maximum intensity for any TEAE: Mild
Group
Value
95% CI
Fesomersen 40 mg
28
Fesomersen 80 mg
28
Fesomersen 120 mg
22
Placebo
27
Maximum intensity for any TEAE: Moderate
Group
Value
95% CI
Fesomersen 40 mg
17
Fesomersen 80 mg
24
Fesomersen 120 mg
28
Placebo
19
Maximum intensity for any TEAE: Severe
Group
Value
95% CI
Fesomersen 40 mg
9
Fesomersen 80 mg
4
Fesomersen 120 mg
5
Placebo
9
Number of Participants With TEAEs During the Main and Extended Treatment Periods and Within the On-treatment Time Window and Their SeveritySecondary· Up to 48 weeks
TEAEs were analyzed during during main and extended treatment periods in the safety analysis set (SAF). Data observed from the randomization date until the end of the extension treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
Any TEAE
Group
Value
95% CI
Fesomersen 40 mg
61
Fesomersen 80 mg
62
Fesomersen 120 mg
58
Placebo
56
Maximum intensity for any TEAE: Mild
Group
Value
95% CI
Fesomersen 40 mg
26
Fesomersen 80 mg
25
Fesomersen 120 mg
20
Placebo
26
Maximum intensity for any TEAE: Moderate
Group
Value
95% CI
Fesomersen 40 mg
24
Fesomersen 80 mg
31
Fesomersen 120 mg
30
Placebo
18
Maximum intensity for any TEAE: Severe
Group
Value
95% CI
Fesomersen 40 mg
11
Fesomersen 80 mg
6
Fesomersen 120 mg
8
Placebo
12
Number of Participants With TEAEs During the Main and Extended Treatment Periods and Until 20 Weeks After the Last Study Intervention Dose and Their SeveritySecondary· Up to 48 weeks
TEAEs occurring from first study intervention intake until 20 weeks after last study intervention intake.
Any TEAE
Group
Value
95% CI
Fesomersen 40 mg
64
Fesomersen 80 mg
63
Fesomersen 120 mg
62
Placebo
59
Maximum intensity for any TEAE: Mild
Group
Value
95% CI
Fesomersen 40 mg
21
Fesomersen 80 mg
21
Fesomersen 120 mg
18
Placebo
21
Maximum intensity for any TEAE: Moderate
Group
Value
95% CI
Fesomersen 40 mg
28
Fesomersen 80 mg
33
Fesomersen 120 mg
33
Placebo
22
Maximum intensity for any TEAE: Severe
Group
Value
95% CI
Fesomersen 40 mg
15
Fesomersen 80 mg
9
Fesomersen 120 mg
11
Placebo
16
Trough Concentrations (Ctrough) of Three Dose Levels of FesomersenSecondary· At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141)
Trough (pre-dose) fesomersen-equivalent plasma concentrations (Ctrough) for 3 dose levels of fesomersen were summarized descriptively by dose level and visit: Visit 12, Visit 14, Visit 16, Visit 18 (main treatment period). Ctrough was not measured for the placebo group.
Visit 12
Group
Value
95% CI
Fesomersen 40 mg
0.000454
± 118.753791
Fesomersen 80 mg
0.000704
± 80.938271
Fesomersen 120 mg
0.001186
± 76.691406
Visit 14
Group
Value
95% CI
Fesomersen 40 mg
0.000490
± 92.511801
Fesomersen 80 mg
0.000792
± 82.170296
Fesomersen 120 mg
0.001246
± 97.530820
Visit 16
Group
Value
95% CI
Fesomersen 40 mg
0.000572
± 85.974878
Fesomersen 80 mg
0.000789
± 68.188121
Fesomersen 120 mg
0.001346
± 81.805680
Visit 18
Group
Value
95% CI
Fesomersen 40 mg
0.000521
± 106.848825
Fesomersen 80 mg
0.000828
± 91.024162
Fesomersen 120 mg
0.001424
± 92.709743
Maximum Change in FXI Activity Levels During the Main Treatment PeriodSecondary· Baseline, Days 1 (Pre-Dose and 5 hours post-dose), 2, 8, 15, 22, 29 (Pre-dose and 5 hours post-dose), 43, 57 (Pre-dose), 71, 85 (Pre-dose), 113 (Pre-dose), 141 (Pre-dose),148, 155, 162, and 169 (Pre-dose)
The FXIa activity was measured by a fluorogenic activated FXIa activity (AXIA) assay. Absolute change from baseline at each visit until Visit 22 (Day 169) are reported.
Baseline
Group
Value
95% CI
Fesomersen 40 mg
0.00
± 0.00
Fesomersen 80 mg
0.00
± 0.00
Fesomersen 120 mg
0.00
± 0.00
Placebo
0.00
± 0.00
Visit 5 (Day 1): Pre-dose
Group
Value
95% CI
Fesomersen 40 mg
0.06
± 0.06
Fesomersen 80 mg
0.05
± 0.06
Fesomersen 120 mg
0.05
± 0.05
Placebo
0.04
± 0.05
Visit 5 (Day 1): 5 Hours
Group
Value
95% CI
Fesomersen 40 mg
0.09
± 0.09
Fesomersen 80 mg
0.11
± 0.12
Fesomersen 120 mg
0.13
± 0.13
Placebo
0.10
± 0.08
Visit 6 (Day 2): 22 Hours
Group
Value
95% CI
Fesomersen 40 mg
0.13
± 0.11
Fesomersen 80 mg
0.12
± 0.12
Fesomersen 120 mg
0.15
± 0.13
Placebo
0.14
± 0.13
Visit 7 (Day 8)
Group
Value
95% CI
Fesomersen 40 mg
0.21
± 0.15
Fesomersen 80 mg
0.32
± 0.15
Fesomersen 120 mg
0.43
± 0.18
Placebo
0.08
± 0.07
Visit 8 (Day 15)
Group
Value
95% CI
Fesomersen 40 mg
0.34
± 0.23
Fesomersen 80 mg
0.48
± 0.21
Fesomersen 120 mg
0.61
± 0.24
Placebo
0.12
± 0.09
Visit 9 (Day 22)
Group
Value
95% CI
Fesomersen 40 mg
0.37
± 0.26
Fesomersen 80 mg
0.50
± 0.23
Fesomersen 120 mg
0.63
± 0.25
Placebo
0.11
± 0.09
Visit 10 (Day 29): Pre-dose
Group
Value
95% CI
Fesomersen 40 mg
0.34
± 0.26
Fesomersen 80 mg
0.44
± 0.21
Fesomersen 120 mg
0.60
± 0.25
Placebo
0.09
± 0.07
Adverse events — posted to ClinicalTrials.gov
Time frame: From first study intervention up to 64 Weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow that causes heart attacks, strokes, and other life-threatening conditions. BAY2976217 is under clinical development for prevention of thrombosis. The goal of the study is to learn more about the safety of BAY2976217, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as multiple doses in participants with renal impairment who require hemodialysis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 3 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04534114.