Trial Outcomes & Findings for A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain (NCT NCT05895552)

Last Updated: 2025-12-15

Results Overview

The NPRS of pain intensity is an 11-point numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participants were asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. The weekly average score of NPRS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. Negative change from baseline indicates decreased pain intensity.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

209 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2025-12-15

Participant Flow

Participants took part at multiple investigative sites from 28 July 2023 to 15 November 2024.

This study was to be conducted in 2 parts: Part 1 to investigate the efficacy and safety of 10 milligrams (mg) and 80 mg doses of RTA 901 and Part 2 to investigate doses of RTA 901 between 1 mg and 80 mg once daily (QD) based on the exposure-response (E-R) analysis for efficacy in Part 1. The study was terminated after Part 1 was completed and did not proceed to Part 2. No participants were enrolled in Part 2.

Participant milestones

Participant milestones
Measure	Part 1: RTA 901 Matching Placebo + Standard-of-care (SOC) Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Overall Study STARTED	69	70	70
Overall Study Treated	68	69	69
Overall Study COMPLETED	65	63	62
Overall Study NOT COMPLETED	4	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: RTA 901 Matching Placebo + Standard-of-care (SOC) Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Overall Study Adverse Event	2	2	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Non-Compliance With Study Drug	0	1	0
Overall Study Protocol Deviation	0	0	2
Overall Study Failure to Meet Randomization Criteria	0	1	1
Overall Study Withdrawal by Subject	2	2	4

Baseline Characteristics

A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: RTA 901 Matching Placebo + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.	Total n=206 Participants Total of all reporting groups
Age, Continuous	65.1 years STANDARD_DEVIATION 7.13 • n=6009 Participants	63.1 years STANDARD_DEVIATION 9.97 • n=42 Participants	64.6 years STANDARD_DEVIATION 7.57 • n=77 Participants	64.3 years STANDARD_DEVIATION 8.33 • n=387 Participants
Sex: Female, Male Female	37 Participants n=6009 Participants	33 Participants n=42 Participants	36 Participants n=77 Participants	106 Participants n=387 Participants
Sex: Female, Male Male	31 Participants n=6009 Participants	36 Participants n=42 Participants	33 Participants n=77 Participants	100 Participants n=387 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	31 Participants n=6009 Participants	34 Participants n=42 Participants	33 Participants n=77 Participants	98 Participants n=387 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	37 Participants n=6009 Participants	35 Participants n=42 Participants	36 Participants n=77 Participants	108 Participants n=387 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	4 Participants n=387 Participants
Race/Ethnicity, Customized Race · Black or African America	14 Participants n=6009 Participants	16 Participants n=42 Participants	15 Participants n=77 Participants	45 Participants n=387 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants
Race/Ethnicity, Customized Race · White	50 Participants n=6009 Participants	49 Participants n=42 Participants	53 Participants n=77 Participants	152 Participants n=387 Participants
Race/Ethnicity, Customized Race · Multiple	0 Participants n=6009 Participants	2 Participants n=42 Participants	0 Participants n=77 Participants	2 Participants n=387 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=6009 Participants	0 Participants n=42 Participants	1 Participants n=77 Participants	2 Participants n=387 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=65 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=63 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=63 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12	-1.71 score on a scale Standard Error 0.249	-1.49 score on a scale Standard Error 0.248	-1.79 score on a scale Standard Error 0.248

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Population: The safety analysis set includes all randomized participants who receive at least 1 dose of randomized study drug.

An adverse event (AE) was any unfavorable and unintended sign (including any CS abnormal laboratory test result), symptom, or disease temporally associated with use of the study drug, whether or not it is considered to be study drug related. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AEs that presented, or worsened in intensity or frequency, following the initiation of study treatment were categorized as TEAEs.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period TEAEs	39 Participants	43 Participants	35 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period SAEs	4 Participants	5 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug.

Clinically significant abnormalities in physical examinations were based on investigator discretion.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Clinically Significant Abnormalities in Physical Examinations	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Vital sign parameters included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \< 36.0 and \> 38.0 degrees Celsius (c), pulse rate \< 60 and \> 100 beats per minute (bpm), systolic blood pressure \< 90, \> 140 and \> 160 millimeters of mercury (mmHg), diastolic blood pressure \< 50, \> 90 and \> 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate \< 12 and \> 20 breaths per minute. The categories with at least one participant with clinically significant vital sign abnormalities are reported.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=67 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Temperature <36 degrees C	15 Participants	17 Participants	16 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Temperature >38 degrees C	0 Participants	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Pulse Rate <60 bpm	18 Participants	6 Participants	11 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Pulse Rate >100 bpm	3 Participants	1 Participants	1 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Systolic Blood Pressure <90 mmHg	0 Participants	0 Participants	3 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Systolic Blood Pressure >140 mmHg	24 Participants	28 Participants	22 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Systolic Blood Pressure >160 mmHg	7 Participants	7 Participants	3 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Diastolic Blood Pressure <50 mmHg	0 Participants	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Diastolic Blood Pressure >90 mmHg	6 Participants	9 Participants	6 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Diastolic Blood Pressure >100 mmHg	1 Participants	2 Participants	0 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Weight 7% or more increase from baseline	1 Participants	1 Participants	2 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Weight 7% or more decrease from baseline	1 Participants	1 Participants	1 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Respiratory Rate <12 breaths/min	1 Participants	0 Participants	0 Participants
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters Respiratory Rate >20 breaths/min	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Clinical significance of abnormalities in ECG was determined based on the investigator's discretion.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=27 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=34 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=30 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG)	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.

Hematology parameters included hematocrit, hemoglobin, erythrocytes, leukocytes, neutrophils, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin concentration. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=67 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Monocytes Shift to High	7 Participants	8 Participants	10 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Monocytes/Leukocytes Shift to Low	0 Participants	2 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Monocytes/Leukocytes Shift to High	3 Participants	5 Participants	9 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Neutrophils Shift to Low	1 Participants	1 Participants	3 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Neutrophils Shift to High	10 Participants	9 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Neutrophils/Leukocytes Shift to Low	2 Participants	4 Participants	3 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Platelets Shift to High	2 Participants	1 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Neutrophils/Leukocytes Shift to High	15 Participants	21 Participants	15 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Platelets Shift to Low	2 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Basophils/Leukocytes Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Basophils/Leukocytes Shift to High	0 Participants	2 Participants	3 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Eosinophils Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Eosinophils Shift to High	6 Participants	5 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Eosinophils/Leukocytes Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Eosinophils/Leukocytes Shift to High	9 Participants	11 Participants	13 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to Low	19 Participants	19 Participants	23 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to High	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Mean Corpuscular Hemoglobin Shift to Low	3 Participants	0 Participants	4 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Mean Corpuscular Hemoglobin Shift to High	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Mean Corpuscular Volume Shift to Low	2 Participants	2 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Mean Corpuscular Volume Shift to High	1 Participants	3 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Shift to Low	7 Participants	6 Participants	10 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Erythrocytes Shift to High	7 Participants	8 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Hematocrit Shift to Low	14 Participants	7 Participants	12 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Hematocrit Shift to High	6 Participants	6 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Hemoglobin Shift to Low	11 Participants	8 Participants	13 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Hemoglobin Shift to High	5 Participants	3 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Hemoglobin A1C/Hemoglobin Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Hemoglobin A1C/Hemoglobin Shift to High	1 Participants	3 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Leukocytes Shift to Low	4 Participants	7 Participants	11 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Leukocytes Shift to High	7 Participants	7 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Lymphocytes Shift to Low	3 Participants	2 Participants	4 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Lymphocytes Shift to High	1 Participants	2 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Lymphocytes/Leukocytes Shift to Low	15 Participants	23 Participants	17 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Monocytes Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) Lymphocytes/Leukocytes Shift to High	7 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, choriogonadotropin beta, follicle stimulating hormone (FSH), estimated glomerular filtration rate (eGFR), ferritin, creatine kinase, blood urea nitrogen, creatinine, bilirubin(total and direct), alkaline phosphatase, amylase, lipase, sodium, potassium, calcium, phosphorus, uric acid, total protein, glucose, albumin, lactate dehydrogenase, magnesium, chloride, bicarbonate, and gamma-glutamyl transferase. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=67 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Amylase Shift to High	12 Participants	11 Participants	9 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Chloride Shift to Low	4 Participants	8 Participants	6 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Cholesterol Shift to High	9 Participants	6 Participants	11 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Direct Bilirubin Shift to High	7 Participants	6 Participants	6 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Ferritin Shift to Low	9 Participants	6 Participants	10 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) LDL Cholesterol Shift to High	11 Participants	10 Participants	11 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Protein Shift to High	1 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Sodium Shift to High	8 Participants	8 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) ALT Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) ALT Shift to High	13 Participants	17 Participants	13 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Albumin Shift to Low	1 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Albumin Shift to High	0 Participants	1 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Alkaline Phosphatase Shift to Low	2 Participants	3 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Alkaline Phosphatase Shift to High	12 Participants	6 Participants	4 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Amylase Shift to Low	1 Participants	2 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) AST Shift to Low	9 Participants	7 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) AST Shift to High	3 Participants	14 Participants	6 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Bicarbonate Shift to Low	2 Participants	1 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Bicarbonate Shift to High	5 Participants	9 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Bilirubin Shift to Low	9 Participants	5 Participants	10 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Bilirubin Shift to High	1 Participants	3 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Calcium Shift to Low	5 Participants	0 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Calcium Shift to High	6 Participants	2 Participants	8 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Chloride Shift to High	6 Participants	7 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Cholesterol Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Creatine Kinase Shift to Low	6 Participants	6 Participants	8 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Creatine Kinase Shift to High	17 Participants	23 Participants	18 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Creatinine Shift to Low	3 Participants	0 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Creatinine Shift to High	16 Participants	11 Participants	15 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Direct Bilirubin Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Ferritin Shift to High	2 Participants	2 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Gamma Glutamyl Transferase Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Gamma Glutamyl Transferase Shift to High	8 Participants	8 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) eGFR Shift to Low	14 Participants	10 Participants	12 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) eGFR Shift to High	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Glucose Shift to Low	1 Participants	2 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Glucose Shift to High	14 Participants	14 Participants	16 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) HDL Cholesterol Shift to Low	8 Participants	11 Participants	12 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) HDL Cholesterol Shift to High	3 Participants	6 Participants	3 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) LDL Cholesterol Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Lactate Dehydrogenase Shift to Low	2 Participants	2 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Lactate Dehydrogenase Shift to High	5 Participants	10 Participants	11 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Lipase Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Lipase Shift to High	17 Participants	22 Participants	23 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Magnesium Shift to Low	4 Participants	5 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Magnesium Shift to High	1 Participants	1 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Phosphate Shift to Low	5 Participants	2 Participants	4 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Phosphate Shift to High	14 Participants	21 Participants	16 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Potassium Shift to Low	0 Participants	2 Participants	2 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Potassium Shift to High	19 Participants	22 Participants	20 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Protein Shift to Low	9 Participants	7 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Sodium Shift to Low	3 Participants	8 Participants	3 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Triglycerides Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Triglycerides Shift to High	17 Participants	16 Participants	21 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Urate Shift to Low	7 Participants	7 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Urate Shift to High	11 Participants	9 Participants	11 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Urea Nitrogen Shift to Low	3 Participants	2 Participants	4 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) Urea Nitrogen Shift to High	14 Participants	23 Participants	15 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Urinalysis included assessments of bacteria, Bilirubin, Calcium Oxalate Crystals, Choriogonadotropin Beta, Color, Erythrocytes, Glucose, Granular Casts, Hyaline Casts, Ketones, Leukocyte Esterase, Leukocytes, Nitrite, Occult Blood, Protein, red blood cells (RBC) Casts, Renal Epithelial Cells, Specific Gravity, Specimen Appearance, Squamous Epithelial Cells, Transitional Epithelial Cells, Triple Phosphate Crystals, Uric Acid Crystals, white blood cells (WBC) Casts and pH. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=67 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Calcium Oxalate Crystals Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Calcium Oxalate Crystals Shift to High	12 Participants	12 Participants	11 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Erythrocytes Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Glucose Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Glucose Shift to High	19 Participants	15 Participants	18 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Granular Casts Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Granular Casts Shift to High	8 Participants	7 Participants	9 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Ketones Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Ketones Shift to High	11 Participants	9 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Leukocyte Esterase Shift to High	18 Participants	19 Participants	23 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Leukocytes Shift to High	18 Participants	14 Participants	13 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Nitrite Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Nitrite Shift to High	5 Participants	7 Participants	7 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Occult Blood Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Occult Blood Shift to High	15 Participants	10 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Protein Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Protein Shift to High	23 Participants	20 Participants	18 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) RBC Casts Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Specific Gravity Shift to Low	8 Participants	11 Participants	12 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) WBC Casts Shift to High	2 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Waxy Casts Shift to High	0 Participants	1 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Yeast Cells Shift to High	4 Participants	1 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) RBC Casts Shift to High	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Specific Gravity Shift to High	24 Participants	24 Participants	20 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Transitional Epithelial Cells Shift to Low	3 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Transitional Epithelial Cells Shift to High	3 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Uric Acid Crystals Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Uric Acid Crystals Shift to High	5 Participants	3 Participants	4 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) WBC Casts Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Waxy Casts Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Yeast Cells Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) pH Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) pH Shift to High	5 Participants	7 Participants	4 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Bilirubin Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Bilirubin Shift to High	0 Participants	0 Participants	1 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Erythrocytes Shift to High	8 Participants	7 Participants	5 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Hyaline Casts Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Hyaline Casts Shift to High	6 Participants	10 Participants	9 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Leukocyte Esterase Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) Leukocytes Shift to Low	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Coagulation included assessments of prothrombin. The parameter was flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=67 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) Prothrombin Time Shift to High	14 Participants	21 Participants	19 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) Prothrombin International Normalized Ratio Shift to Low	0 Participants	0 Participants	0 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) Prothrombin International Normalized Ratio Shift to High	13 Participants	20 Participants	16 Participants
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) Prothrombin Time Shift to Low	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to end of follow-up period (up to 16 weeks)

Weight decrease was characterized by a decrease of ≥7% from baseline and weight increase was characterized by an increase of ≥7% from baseline.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=67 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants With Clinically Significant Abnormality in Body Weight Weight 7% or more increase from baseline	1 Participants	1 Participants	2 Participants
Number of Participants With Clinically Significant Abnormality in Body Weight Weight 7% or more decrease from baseline	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

Responders is defined as participants with at least \>=30% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12 and were analysed using a logistic regression. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. Lower scores indicate less pain.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants Who Achieved at Least a >=30% Decrease From Baseline in the Average NPRS Score at Week 12	26 Participants	22 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

Responder is defined as participants with at least \>=50% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants Who Achieved at Least a >=50% Decrease From Baseline in the Average NPRS Score at Week 12	17 Participants	12 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

Rescue medication for diabetic peripheral neuropathic pain (DPNP) is in addition to standard of care medication (gabapentin, pregabalin or duloxetine) for DPNP. Rescue medication is intended to treat temporary elevations in a participant's DPNP and is intended to be used occasionally and not meant to be used for prolonged periods of time.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Number of Participants Using Rescue Medications During the Treatment Period Week 4	18 Participants	13 Participants	18 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 5	15 Participants	11 Participants	18 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 6	14 Participants	10 Participants	16 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 7	10 Participants	14 Participants	16 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 8	14 Participants	14 Participants	19 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 9	11 Participants	10 Participants	13 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 10	7 Participants	10 Participants	15 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 11	9 Participants	10 Participants	12 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 12	10 Participants	13 Participants	14 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 2	19 Participants	16 Participants	19 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 3	20 Participants	15 Participants	22 Participants
Number of Participants Using Rescue Medications During the Treatment Period Week 1	20 Participants	15 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.

The amount of rescue medication used per day during the 12-week treatment period was calculated as the total dosage recorded divided by total days of study drug exposure during the treatment period.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=68 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Amount of Rescue Medications Used During the Treatment Period NSAIDs	18.40 milligrams (mg) per day Standard Deviation 64.400	14.72 milligrams (mg) per day Standard Deviation 51.060	48.15 milligrams (mg) per day Standard Deviation 166.396
Amount of Rescue Medications Used During the Treatment Period Acetaminophen	55.50 milligrams (mg) per day Standard Deviation 146.374	91.31 milligrams (mg) per day Standard Deviation 308.725	101.09 milligrams (mg) per day Standard Deviation 268.488

SECONDARY outcome

Timeframe: Up to Week 12

Time to first occurrence of rescue medication use was defined as the time from first randomized dose to the first date of rescue medication use recorded in e-diary during the 12-week treatment period. If a participant withdraws from the study prior to week 12 and the participant did not take any rescue medication, then the participant will be censored on the last day in the study.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=28 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=28 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=34 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Time to First Occurrence of Rescue Medication Use	NA days Interval 16.0 to Median and upper values of 95% confidence interval were not estimable due to an insufficient number of participants with events.	NA days Interval 52.0 to Median and upper values of 95% confidence interval were not estimable due to an insufficient number of participants with events.	NA days Interval 15.0 to Median and upper values of 95% confidence interval were not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline, Week 12

DSIS is a participant reported outcome that was developed to quantify sleep interference due to pain. The DSIS was completed daily by participants upon waking, preferably in the morning, to accurately capture variability in sleep interference due to pain, thus minimizing recall bias. Using the e-diary, participants assessed how neuropathic pain has interfered with their sleep during the past 24 hours. This score ranges from 0 to 10; 0 representing no interference with sleep to 10 representing complete inability to sleep, lower score indicating less pain interference during sleep. The weekly average score of DSIS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. A negative change from baseline indicates decreased interference in sleep due to pain.

Outcome measures

Outcome measures
Measure	Part 1: RTA 901 Matching Placebo + SOC n=66 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=63 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=63 Participants Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Change From Baseline in the Weekly Average of Daily Sleep Interference Scale (DSIS) Score at Week 12	-1.52 score on a scale Standard Deviation 2.035	-1.41 score on a scale Standard Deviation 1.749	-2.00 score on a scale Standard Deviation 2.249

Adverse Events

Part 1: RTA 901 Matching Placebo

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Part 1: RTA 901 10 mg + SOC

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Part 1: RTA 901 80 mg + SOC

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: RTA 901 Matching Placebo n=68 participants at risk Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 participants at risk Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 participants at risk Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Cardiac disorders Acute myocardial infarction	0.00% 0/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Cardiac disorders Supraventricular tachycardia	1.5% 1/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Gastrointestinal disorders Abdominal pain lower	1.5% 1/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Gastrointestinal disorders Constipation	0.00% 0/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Metabolism and nutrition disorders Diabetic ketoacidosis	1.5% 1/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.5% 1/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Nervous system disorders Dizziness	0.00% 0/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Renal and urinary disorders Haematuria	0.00% 0/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Renal and urinary disorders Renal artery stenosis	0.00% 0/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	0.00% 0/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.

Other adverse events

Other adverse events
Measure	Part 1: RTA 901 Matching Placebo n=68 participants at risk Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 10 mg + SOC n=69 participants at risk Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period.	Part 1: RTA 901 80 mg + SOC n=69 participants at risk Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period.
Infections and infestations Upper respiratory tract infection	7.4% 5/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	4.3% 3/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Infections and infestations Urinary tract infection	7.4% 5/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	11.6% 8/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	5.8% 4/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Investigations Blood creatine phosphokinase increased	2.9% 2/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	2.9% 2/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	5.8% 4/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Investigations Lipase increased	5.9% 4/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	5.8% 4/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	1.4% 1/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.
Metabolism and nutrition disorders Hyperkalaemia	1.5% 1/68 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	7.2% 5/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.	2.9% 2/69 • From the first dose of study drug up to end of follow-up period (Week 16) Adverse Events: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. All Cause Mortality: All randomized participants were included.

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER