Trial Outcomes & Findings for An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants (NCT NCT05013008)

Last Updated: 2023-09-15

Results Overview

The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2\^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

951 participants

Primary outcome timeframe

At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment

Results posted on

2023-09-15

Participant Flow

The study was conducted at multiple centers in 21 countries/regions between 18 August 2021 (first subject first visit) and 31 December 2021 (last subject last visit).

Overall, 952 participants from previous FIGARO-DKD study (NCT02545049) were screened for this FIGAGRO-BM study. Of the 952 screened (i.e. signed informed consent available either for this FIGARO-BM study or for the protocol addendum for FIGARO-DKD), 1 participant was a screening failure and 30 participants missed treatment and/or biomarker data at Visit 3 or 11 in FIGARO-DKD. The remaining 921 participants were included in the modified biomarker full analysis set of FIGAGRO-BM study.

Participant milestones

Participant milestones
Measure	Finerenone Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.	Placebo Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.
Overall Study STARTED	483	468
Overall Study mBFAS	478	443
Overall Study COMPLETED	478	443
Overall Study NOT COMPLETED	5	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Finerenone Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.	Placebo Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.
Overall Study Exclusion from mBFAS	5	25

Baseline Characteristics

Participants in mBFAS with available data for each biomarker measurement

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment

Population: Participants in mBFAS with available data for each biomarker measurement

Outcome measures

Outcome measures
Measure	Finerenone n=478 Participants Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.	Placebo n=443 Participants Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers CCN family member 4 (O95388)	1.109 Ratio Standard Deviation 1.266	1.164 Ratio Standard Deviation 1.329
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Transforming growth factor beta-1 proprotein (P01137)	1.122 Ratio Standard Deviation 1.312	1.184 Ratio Standard Deviation 1.369
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Transforming growth factor beta receptor type 3 (Q03167)	1.133 Ratio Standard Deviation 1.687	1.224 Ratio Standard Deviation 1.649
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Proto-oncogene tyrosine-protein kinase Src (P12931)	0.926 Ratio Standard Deviation 2.902	1.000 Ratio Standard Deviation 2.492
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Protein AMBP (P02760)	1.034 Ratio Standard Deviation 1.168	1.045 Ratio Standard Deviation 1.166
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Aminopeptidase N (P15144)	1.005 Ratio Standard Deviation 1.263	1.020 Ratio Standard Deviation 1.316
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Tumor necrosis factor receptor superfamily member 1A (P19438)	1.151 Ratio Standard Deviation 1.506	1.184 Ratio Standard Deviation 1.516
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Urokinase plasminogen activator surface receptor (Q03405)	1.109 Ratio Standard Deviation 1.661	1.127 Ratio Standard Deviation 1.379
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers C-C motif chemokine 14 (Q16627)	1.072 Ratio Standard Deviation 1.617	1.092 Ratio Standard Deviation 1.401
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers C-C motif chemokine 16 (O15467)	1.044 Ratio Standard Deviation 1.607	1.055 Ratio Standard Deviation 1.416
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Matrix metalloproteinase-9 (P14780)	1.074 Ratio Standard Deviation 2.303	1.080 Ratio Standard Deviation 2.108
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers C-X-C motif chemokine 16 (Q9H2A7)	1.058 Ratio Standard Deviation 1.562	1.063 Ratio Standard Deviation 1.330
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Matrilysin (P09237)	1.014 Ratio Standard Deviation 1.125	1.062 Ratio Standard Deviation 1.201
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers von Willebrand factor (P04275)	0.979 Ratio Standard Deviation 1.773	1.131 Ratio Standard Deviation 1.765
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Interleukin-15 receptor subunit alpha (Q13261)	1.121 Ratio Standard Deviation 1.402	1.179 Ratio Standard Deviation 1.442
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Metalloproteinase inhibitor 1 (P01033)	1.056 Ratio Standard Deviation 1.456	1.105 Ratio Standard Deviation 1.381
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Pappalysin-1 (Q13219)	1.088 Ratio Standard Deviation 3.371	1.273 Ratio Standard Deviation 3.034
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Uromodulin (P07911)	0.980 Ratio Standard Deviation 1.513	0.956 Ratio Standard Deviation 1.388
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Plasminogen activator inhibitor 1 (P05121)	0.945 Ratio Standard Deviation 2.089	0.972 Ratio Standard Deviation 1.909
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers CCN family member 2 (P29279)	1.083 Ratio Standard Deviation 1.548	1.103 Ratio Standard Deviation 1.395
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Collagen alpha-1(I) chain (P02452)	1.101 Ratio Standard Deviation 1.680	1.112 Ratio Standard Deviation 1.534
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Decorin (P07585)	1.086 Ratio Standard Deviation 1.202	1.088 Ratio Standard Deviation 1.250
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers C-C motif chemokine 2 (P13500)	1.001 Ratio Standard Deviation 1.329	1.003 Ratio Standard Deviation 1.409
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers E-selectin (P16581)	1.009 Ratio Standard Deviation 1.681	1.010 Ratio Standard Deviation 1.432
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Thrombospondin-2 (P35442)	1.054 Ratio Standard Deviation 1.533	1.056 Ratio Standard Deviation 1.533
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Retinoic acid receptor responder protein 2 (Q99969)	1.035 Ratio Standard Deviation 1.569	1.022 Ratio Standard Deviation 1.517
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers Dickkopf-related protein 3 (Q9UBP4)	1.050 Ratio Standard Deviation 1.452	1.055 Ratio Standard Deviation 1.427

Adverse Events

Finerenone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head

Bayer

Phone: 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Finerenone n=478 Participants Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.	Placebo n=443 Participants Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.	Total n=921 Participants Total of all reporting groups
Age, Continuous	63.55 years STANDARD_DEVIATION 9.50 • n=478 Participants	64.15 years STANDARD_DEVIATION 9.65 • n=443 Participants	63.84 years STANDARD_DEVIATION 9.57 • n=921 Participants
Sex: Female, Male Female	120 Participants n=478 Participants	112 Participants n=443 Participants	232 Participants n=921 Participants
Sex: Female, Male Male	358 Participants n=478 Participants	331 Participants n=443 Participants	689 Participants n=921 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=478 Participants	0 Participants n=443 Participants	1 Participants n=921 Participants
Race (NIH/OMB) Asian	173 Participants n=478 Participants	151 Participants n=443 Participants	324 Participants n=921 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=478 Participants	1 Participants n=443 Participants	1 Participants n=921 Participants
Race (NIH/OMB) Black or African American	8 Participants n=478 Participants	7 Participants n=443 Participants	15 Participants n=921 Participants
Race (NIH/OMB) White	293 Participants n=478 Participants	283 Participants n=443 Participants	576 Participants n=921 Participants
Race (NIH/OMB) More than one race	2 Participants n=478 Participants	0 Participants n=443 Participants	2 Participants n=921 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=478 Participants	1 Participants n=443 Participants	2 Participants n=921 Participants
Plasma biomarker levels after 4 months of treatment Matrilysin (P09237)	19.618 Linear NPX (2^NPX) STANDARD_DEVIATION 1.148 • n=427 Participants • Participants in mBFAS with available data for each biomarker measurement	18.956 Linear NPX (2^NPX) STANDARD_DEVIATION 1.203 • n=403 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=830 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment von Willebrand factor (P04275)	3.200 Linear NPX (2^NPX) STANDARD_DEVIATION 1.793 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	2.338 Linear NPX (2^NPX) STANDARD_DEVIATION 1.629 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment CCN family member 4 (O95388)	1.600 Linear NPX (2^NPX) STANDARD_DEVIATION 1.337 • n=470 Participants • Participants in mBFAS with available data for each biomarker measurement	1.578 Linear NPX (2^NPX) STANDARD_DEVIATION 1.374 • n=436 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Transforming growth factor beta-1 proprotein (P01137)	1.480 Linear NPX (2^NPX) STANDARD_DEVIATION 1.327 • n=471 Participants • Participants in mBFAS with available data for each biomarker measurement	1.425 Linear NPX (2^NPX) STANDARD_DEVIATION 1.349 • n=436 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=907 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Transforming growth factor beta receptor type 3 (Q03167)	1.583 Linear NPX (2^NPX) STANDARD_DEVIATION 1.631 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	1.776 Linear NPX (2^NPX) STANDARD_DEVIATION 1.624 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Interleukin-15 receptor subunit alpha (Q13261)	1.678 Linear NPX (2^NPX) STANDARD_DEVIATION 1.432 • n=435 Participants • Participants in mBFAS with available data for each biomarker measurement	1.614 Linear NPX (2^NPX) STANDARD_DEVIATION 1.450 • n=408 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=843 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Metalloproteinase inhibitor 1 (P01033)	1.818 Linear NPX (2^NPX) STANDARD_DEVIATION 1.450 • n=432 Participants • Participants in mBFAS with available data for each biomarker measurement	1.824 Linear NPX (2^NPX) STANDARD_DEVIATION 1.349 • n=408 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=840 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Pappalysin-1 (Q13219)	0.171 Linear NPX (2^NPX) STANDARD_DEVIATION 3.066 • n=435 Participants • Participants in mBFAS with available data for each biomarker measurement	0.164 Linear NPX (2^NPX) STANDARD_DEVIATION 2.762 • n=408 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=843 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Proto-oncogene tyrosine-protein kinase Src (P12931)	1.770 Linear NPX (2^NPX) STANDARD_DEVIATION 2.614 • n=471 Participants • Participants in mBFAS with available data for each biomarker measurement	1.535 Linear NPX (2^NPX) STANDARD_DEVIATION 2.229 • n=438 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=909 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Protein AMBP (P02760)	1.595 Linear NPX (2^NPX) STANDARD_DEVIATION 1.226 • n=470 Participants • Participants in mBFAS with available data for each biomarker measurement	1.611 Linear NPX (2^NPX) STANDARD_DEVIATION 1.225 • n=436 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Uromodulin (P07911)	0.582 Linear NPX (2^NPX) STANDARD_DEVIATION 1.752 • n=443 Participants • Participants in mBFAS with available data for each biomarker measurement	0.699 Linear NPX (2^NPX) STANDARD_DEVIATION 1.531 • n=405 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=848 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Aminopeptidase N (P15144)	1.224 Linear NPX (2^NPX) STANDARD_DEVIATION 1.273 • n=461 Participants • Participants in mBFAS with available data for each biomarker measurement	1.248 Linear NPX (2^NPX) STANDARD_DEVIATION 1.300 • n=433 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=894 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Tumor necrosis factor receptor superfamily member 1A (P19438)	2.105 Linear NPX (2^NPX) STANDARD_DEVIATION 1.606 • n=476 Participants • Participants in mBFAS with available data for each biomarker measurement	2.107 Linear NPX (2^NPX) STANDARD_DEVIATION 1.575 • n=441 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=917 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Plasminogen activator inhibitor 1 (P05121)	1.349 Linear NPX (2^NPX) STANDARD_DEVIATION 2.148 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	1.261 Linear NPX (2^NPX) STANDARD_DEVIATION 1.868 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment CCN family member 2 (P29279)	1.245 Linear NPX (2^NPX) STANDARD_DEVIATION 1.585 • n=473 Participants • Participants in mBFAS with available data for each biomarker measurement	1.258 Linear NPX (2^NPX) STANDARD_DEVIATION 1.360 • n=439 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=912 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Urokinase plasminogen activator surface receptor (Q03405)	1.744 Linear NPX (2^NPX) STANDARD_DEVIATION 1.699 • n=473 Participants • Participants in mBFAS with available data for each biomarker measurement	1.725 Linear NPX (2^NPX) STANDARD_DEVIATION 1.398 • n=439 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=912 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment C-C motif chemokine 14 (Q16627)	3.013 Linear NPX (2^NPX) STANDARD_DEVIATION 1.667 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	3.056 Linear NPX (2^NPX) STANDARD_DEVIATION 1.426 • n=441 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=913 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment C-C motif chemokine 16 (O15467)	1.625 Linear NPX (2^NPX) STANDARD_DEVIATION 1.776 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	1.633 Linear NPX (2^NPX) STANDARD_DEVIATION 1.637 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Collagen alpha-1(I) chain (P02452)	0.646 Linear NPX (2^NPX) STANDARD_DEVIATION 1.675 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	0.693 Linear NPX (2^NPX) STANDARD_DEVIATION 1.497 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Decorin (P07585)	1.523 Linear NPX (2^NPX) STANDARD_DEVIATION 1.233 • n=427 Participants • Participants in mBFAS with available data for each biomarker measurement	1.526 Linear NPX (2^NPX) STANDARD_DEVIATION 1.233 • n=403 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=830 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment C-C motif chemokine 2 (P13500)	3.065 Linear NPX (2^NPX) STANDARD_DEVIATION 1.285 • n=444 Participants • Participants in mBFAS with available data for each biomarker measurement	3.209 Linear NPX (2^NPX) STANDARD_DEVIATION 1.367 • n=407 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=851 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Matrix metalloproteinase-9 (P14780)	1.329 Linear NPX (2^NPX) STANDARD_DEVIATION 2.202 • n=476 Participants • Participants in mBFAS with available data for each biomarker measurement	1.176 Linear NPX (2^NPX) STANDARD_DEVIATION 1.985 • n=441 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=917 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment E-selectin (P16581)	1.235 Linear NPX (2^NPX) STANDARD_DEVIATION 1.828 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	1.200 Linear NPX (2^NPX) STANDARD_DEVIATION 1.577 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Thrombospondin-2 (P35442)	1.421 Linear NPX (2^NPX) STANDARD_DEVIATION 1.655 • n=476 Participants • Participants in mBFAS with available data for each biomarker measurement	1.452 Linear NPX (2^NPX) STANDARD_DEVIATION 1.649 • n=441 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=917 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Retinoic acid receptor responder protein 2 (Q99969)	2.201 Linear NPX (2^NPX) STANDARD_DEVIATION 1.580 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	2.252 Linear NPX (2^NPX) STANDARD_DEVIATION 1.418 • n=441 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=913 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment C-X-C motif chemokine 16 (Q9H2A7)	1.341 Linear NPX (2^NPX) STANDARD_DEVIATION 1.586 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	1.353 Linear NPX (2^NPX) STANDARD_DEVIATION 1.338 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement
Plasma biomarker levels after 4 months of treatment Dickkopf-related protein 3 (Q9UBP4)	1.827 Linear NPX (2^NPX) STANDARD_DEVIATION 1.541 • n=472 Participants • Participants in mBFAS with available data for each biomarker measurement	1.925 Linear NPX (2^NPX) STANDARD_DEVIATION 1.460 • n=434 Participants • Participants in mBFAS with available data for each biomarker measurement	NA Linear NPX (2^NPX) STANDARD_DEVIATION NA • n=906 Participants • Participants in mBFAS with available data for each biomarker measurement