Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease (NCT NCT04026165)

Last Updated: 2022-12-21

Results Overview

The values of eGFRcr were calculated using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation (2009). eGFRcr = 141\*min(Standardized Serum Creatinine (Scr)/kappa, 1) \^alpha\*max(Scr/ kappa, 1)\^(-1.209)\*0.993\^Age\*1.018\[if female\]\*1.159\[if Black\], where kappa=0.7(females) or 0.9(males), alpha=-0.329(females) or -0.411(males). min indicates the minimum of Scr/kappa or 1, max indicates the maximum of Scr/kappa or 1, and age is in years. Treatment-specific Baselines = the average of Visits A and B values for Placebo, and the average of Visit C and Day 1 values for SEL. Visit A= enrollment, Visit B= 7-14 days after Visit A, Visit C= 21-28 days after Visit B, and Visit 1= 7-14 days after Visit C.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

384 participants

Primary outcome timeframe

Treatment-specific Baselines (From enrollment (Visit A) up to 14 days after Visit A for placebo and from Visit C up to 14 days after Visit C for SEL)

Results posted on

2022-12-21

Participant Flow

Participants were enrolled at study sites in the United States, Japan, Canada, New Zealand, and Australia.

961 participants were screened.

Participant milestones

Participant milestones
Measure	Run-in Placebo Participants received placebo to match selonsertib (SEL) tablet orally once daily for at least one week.	Run-in SEL 18 mg Participants received SEL 18 mg tablet orally once daily for at least 4 weeks.	Randomized SEL 18 mg Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
Run-in Placebo Period STARTED	384	0	0	0
Run-in Placebo Period COMPLETED	362	0	0	0
Run-in Placebo Period NOT COMPLETED	22	0	0	0
Run-in SEL Period STARTED	0	357	0	0
Run-in SEL Period COMPLETED	0	311	0	0
Run-in SEL Period NOT COMPLETED	0	46	0	0
Randomized Period STARTED	0	0	154	156
Randomized Period COMPLETED	0	0	140	137
Randomized Period NOT COMPLETED	0	0	14	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-in Placebo Participants received placebo to match selonsertib (SEL) tablet orally once daily for at least one week.	Run-in SEL 18 mg Participants received SEL 18 mg tablet orally once daily for at least 4 weeks.	Randomized SEL 18 mg Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
Run-in Placebo Period Enrollment Error	13	0	0	0
Run-in Placebo Period Run-in Failure	4	0	0	0
Run-in Placebo Period Protocol Violation	2	0	0	0
Run-in Placebo Period Withdrew Consent	2	0	0	0
Run-in Placebo Period Significant Non-Compliance with Study Drug	1	0	0	0
Run-in SEL Period Run-in Failure	0	26	0	0
Run-in SEL Period Withdrew Consent	0	10	0	0
Run-in SEL Period Enrollment Error	0	4	0	0
Run-in SEL Period Protocol Violation	0	3	0	0
Run-in SEL Period Investigator's Discretion	0	2	0	0
Run-in SEL Period Death	0	1	0	0
Randomized Period Withdrew Consent	0	0	5	8
Randomized Period Death	0	0	5	7
Randomized Period Investigator's Discretion	0	0	2	2
Randomized Period Lost to Follow-up	0	0	2	2

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Run-in SEL 18 mg, Not Randomized n=47 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period and were not randomized.	Randomized SEL 18 mg n=154 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo n=156 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.	Total n=357 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 9.7 • n=5 Participants	65 years STANDARD_DEVIATION 9.3 • n=7 Participants	66 years STANDARD_DEVIATION 8.8 • n=5 Participants	65 years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	48 Participants n=7 Participants	51 Participants n=5 Participants	111 Participants n=4 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	106 Participants n=7 Participants	105 Participants n=5 Participants	246 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=5 Participants	132 Participants n=7 Participants	136 Participants n=5 Participants	307 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants	41 Participants n=7 Participants	44 Participants n=5 Participants	89 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=5 Participants	26 Participants n=7 Participants	22 Participants n=5 Participants	52 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	36 Participants n=5 Participants	78 Participants n=7 Participants	84 Participants n=5 Participants	198 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment New Zealand	0 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	15 participants n=4 Participants
Region of Enrollment Canada	8 participants n=5 Participants	11 participants n=7 Participants	9 participants n=5 Participants	28 participants n=4 Participants
Region of Enrollment United States	38 participants n=5 Participants	96 participants n=7 Participants	99 participants n=5 Participants	233 participants n=4 Participants
Region of Enrollment Japan	1 participants n=5 Participants	38 participants n=7 Participants	37 participants n=5 Participants	76 participants n=4 Participants
Region of Enrollment Australia	0 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants

PRIMARY outcome

Timeframe: Treatment-specific Baselines (From enrollment (Visit A) up to 14 days after Visit A for placebo and from Visit C up to 14 days after Visit C for SEL)

Population: The Full Analysis Set included all participants who were randomized in the study, and received at least one dose of study drug in the Randomization Phase.

Outcome measures

Outcome measures
Measure	Randomized SEL 18 mg n=154 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo n=156 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr)	32.7 mL/min/1.73m^2 Standard Deviation 10.59	34.9 mL/min/1.73m^2 Standard Deviation 10.81

PRIMARY outcome

Timeframe: Treatment-specific Baselines through Week 84

Population: Participants in the Full Analysis Set (included all participants who were randomized in the study and received at least 1 dose of study drug in the randomization phase) with available data were analyzed.

The values of eGFRcr were calculated using the CKD-EPI Creatinine Equation (2009). eGFRcr = 141\*min(Scr/kappa, 1) \^alpha\*max(Scr/kappa, 1)\^(-1.209)\*0.993\^Age\*1.018\[if female\]\*1.159\[if Black\], where kappa=0.7(females) or 0.9(males), alpha=-0.329(females) or -0.411(males). min indicates the minimum of Scr/kappa or 1, max indicates the maximum of Scr/kappa or 1, and age is in years. Treatment specific baselines for eGFRcr: average of Visit A (enrollment) and Visit B (7-14 days after Visit A) values for Placebo, and average of Visit C (21-28 days after Visit B, and Visit 1 (7-14 days after Visit C) values for SEL.

Outcome measures

Outcome measures
Measure	Randomized SEL 18 mg n=153 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo n=156 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
eGFRcr Slope	-2.29 mL/min/1.73m^2/year Standard Error 0.58	-3.49 mL/min/1.73m^2/year Standard Error 0.58

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Randomized SEL 18 mg n=154 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo n=156 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
Percentage of Participants With Kidney Clinical Events at Week 48	9.1 percentage of participants	9.0 percentage of participants

SECONDARY outcome

Timeframe: From randomization up to Week 101

Population: Participants in the Full Analysis Set were analyzed.

Kidney clinical events were defined as any of the following events: confirmed ≥ 40% decline in eGFRcr from baseline, or kidney failure (dialysis performed for at least 4 weeks, kidney transplantation, or confirmed decrease in eGFRcr to \< 15 mL/min/1.73 m\^2 for participants without dialysis or kidney transplantation), or death due to kidney disease. This outcome measure was analyzed using event rate per 100 participant-years for first occurrence of kidney clinical event. Participant year was calculated as total follow-up duration across all participants in a given group. Follow-up duration was defined as time from Randomization to the earliest of study completion, premature study discontinuation, death, or event of interest in each row.

Outcome measures

Outcome measures
Measure	Randomized SEL 18 mg n=154 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo n=156 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
Time From Randomization to First Occurrence of a Kidney Clinical Event: Event Rate Per 100 Participant-years for First Occurrence of Kidney Clinical Event	13.4 events per 100 participant-years	9.8 events per 100 participant-years

SECONDARY outcome

Timeframe: Pre-run-in Baseline (Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values)

Population: Participants in the Full Analysis Set were analyzed.

eGFRcys = Estimated Glomerular Filtration Rate calculated by CKD-EPI Cystatin C Equation (2012). eGFR = 133\*min(Standardized Serum Cystatin (Scys)/0.8, 1) \^(-0.499)\*max(Scys/0.8, 1)\^(-1.328)\*0.996\^Age\*0.932\[if female\]. min indicates the minimum of Scys/0.8 or 1, max indicates the maximum of Scr/0.8 or 1, and age is in years.

Outcome measures

Outcome measures
Measure	Randomized SEL 18 mg n=154 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo n=156 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
Pre-run-in Baseline Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys)	33.6 mL/min/1.73m^2 Standard Deviation 11.81	32.4 mL/min/1.73m^2 Standard Deviation 10.94

SECONDARY outcome

Timeframe: Pre-run-in Baseline through Week 84

Population: Participants in the Full Analysis Set with available data were analyzed.

eGFRcys = Estimated Glomerular Filtration Rate calculated by CKD-EPI Cystatin C Equation (2012). eGFR = 133\*min(Scys/0.8, 1) \^(-0.499)\*max(Scys/0.8, 1)\^(-1.328)\*0.996\^Age\*0.932\[if female\]. min indicates the minimum of Scys/0.8 or 1, max indicates the maximum of Scr/0.8 or 1, and age is in years. Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values.

Outcome measures

Outcome measures
Measure	Randomized SEL 18 mg n=153 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received SEL 18 mg tablet orally once daily for at least 48 weeks.	Randomized Placebo n=156 Participants Participants received SEL 18 mg tablet orally once daily for at least 4 weeks in the Run-in period, were then randomized, and received placebo-to-match SEL tablet orally once daily for at least 48 weeks.
eGFRcys Slope	-3.79 mL/min/1.73m^2/year Standard Error 0.51	-4.23 mL/min/1.73m^2/year Standard Error 0.51

Adverse Events

Run-in Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Run-in SEL 18 mg

Serious events: 16 serious events

Other events: 37 other events

Deaths: 1 deaths

Randomized SEL 18 mg

Serious events: 45 serious events

Other events: 55 other events

Deaths: 5 deaths

Randomized Placebo

Serious events: 45 serious events

Other events: 49 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Run-in Placebo Participants received placebo-to-match SEL tablet orally once daily for at least one week.	Run-in SEL 18 mg n=357 participants at risk Participants received SEL 18 mg tablet orally once daily for at least 4 weeks.	Randomized SEL 18 mg n=154 participants at risk Participants received SEL 18 mg tablet orally once daily for at least 48 weeks after Randomization.	Randomized Placebo n=156 participants at risk Participants received placebo-to-match SEL tablet orally once daily for at least 48 weeks after Randomization.
Blood and lymphatic system disorders Anaemia	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	0.28% 1/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	3.2% 5/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	5.1% 8/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.
Gastrointestinal disorders Constipation	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	2.0% 7/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	7.1% 11/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	1.9% 3/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.
General disorders Oedema peripheral	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	1.4% 5/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	7.1% 11/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	5.1% 8/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.
Infections and infestations Urinary tract infection	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	1.7% 6/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	3.2% 5/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	5.8% 9/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.
Metabolism and nutrition disorders Hyperkalaemia	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	2.2% 8/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	7.8% 12/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	7.1% 11/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.
Metabolism and nutrition disorders Hypoglycaemia	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	1.1% 4/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	3.9% 6/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	5.8% 9/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.
Renal and urinary disorders Acute kidney injury	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	0.28% 1/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	6.5% 10/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	2.6% 4/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.
Vascular disorders Hypertension	— 0/0 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	2.8% 10/357 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	7.1% 11/154 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.	4.5% 7/156 • All-Cause Mortality: Enrollment up to maximum duration of 107.1 weeks; Adverse Events: First dose in Run-in SEL phase up to last dose (maximum: 101 weeks) plus 30 days All-Cause Mortality: The All Enrolled Analysis Set included all participants who were enrolled in the study. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of Run-in SEL.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER