Trial Outcomes & Findings for A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH) (NCT NCT03551522)

Last Updated: 2022-09-15

Results Overview

Evaluate the effect of seladelpar on hepatic fat fraction, as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12 in the double-blind (DB) phase. MRI-PDFF Relative (Percent) Change From Baseline to Week 12 - ANCOVA - mITT Population MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

181 participants

Primary outcome timeframe

Week 12

Results posted on

2022-09-15

Participant Flow

DB Phase: A total of 181 subjects were randomly assigned to receive placebo, seladelpar 10 mg/day, seladelpar 20 mg/day, or seladelpar 50 mg/day (1:2:2:2 ratio). Subjects were stratified by diabetic status (yes/no) and fibrosis stage (F1 versus F2-3). Study drug (placebo or seladelpar) was taken in a blinded manner orally once a day for a period of 52 weeks. OLE Phase: All subjects will receive seladelpar 50 mg regardless of dose received during the DB phase.

Participant milestones

Participant milestones
Measure	Period 1: Seladelpar 10 mg DB Phase. Subjects were randomized to receive seladelpar 10 mg daily for 52 weeks.	Period 1: Seladelpar 20 mg DB Phase. Subjects were randomized to receive seladelpar 20 mg daily for 52 weeks.	Period 1: Seladelpar 50 mg DB Phase. Subjects were randomized to receive seladelpar 50 mg daily for 52 weeks.	Period 1: Placebo DB Phase. Subjects were randomized to receive placebo daily for 52 weeks.	Period 2: Seladelpar 50 mg OLE phase: All subjects received seladelpar 50 mg
DB Phase STARTED	53	51	50	27	0
DB Phase COMPLETED	27	34	32	17	0
DB Phase NOT COMPLETED	26	17	18	10	0
OLE Phase STARTED	0	0	0	0	12
OLE Phase COMPLETED	0	0	0	0	0
OLE Phase NOT COMPLETED	0	0	0	0	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seladelpar 10 mg n=53 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=51 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=50 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=27 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule	Total n=181 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 12.48 • n=93 Participants	56.6 years STANDARD_DEVIATION 11.74 • n=4 Participants	53.7 years STANDARD_DEVIATION 11.18 • n=27 Participants	53.9 years STANDARD_DEVIATION 10.27 • n=483 Participants	54.4 years STANDARD_DEVIATION 11.60 • n=36 Participants
Sex: Female, Male Female	36 Participants n=93 Participants	35 Participants n=4 Participants	33 Participants n=27 Participants	18 Participants n=483 Participants	122 Participants n=36 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	16 Participants n=4 Participants	17 Participants n=27 Participants	9 Participants n=483 Participants	59 Participants n=36 Participants
Race/Ethnicity, Customized White	50 Participants n=93 Participants	47 Participants n=4 Participants	49 Participants n=27 Participants	27 Participants n=483 Participants	173 Participants n=36 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized American Indian or Alaska native	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Region of Enrollment United States	53 participants n=93 Participants	51 participants n=4 Participants	50 participants n=27 Participants	27 participants n=483 Participants	181 participants n=36 Participants

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population: defined as any subject who was randomized, received at least one dose of study drug, and had Baseline and Week 12 MRI-PDFF.

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=50 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=47 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=48 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=26 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF)	-9.76 percentage of change from Baseline Standard Error 4.153	-14.24 percentage of change from Baseline Standard Error 4.329	-13.00 percentage of change from Baseline Standard Error 4.305	-20.78 percentage of change from Baseline Standard Error 5.555

SECONDARY outcome

Timeframe: Week 52

Population: mITTb population: The mITTb population is defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 52/ET liver biopsies.

Histopathology nonalcoholic fatty liver disease activity score (NAS) change from baseline ≤-2 (Improvements of 2 points or more in NAS) - mITT Population Total NAS score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8. Diagnosis of NASH (or, alternatively, fatty liver not diagnostic of NASH) should be made first, then NAS is used to grade activity. NAS scores of 0-2 occurred in cases largely considered not diagnostic of NASH, scores of 3-4 were evenly divided among those considered not diagnostic, borderline, or positive for NASH. Scores of 5-8 occurred in cases that were largely considered diagnostic of NASH

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=39 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=42 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=46 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=25 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Percentage of Participants With Improvement of 2 Points or More in the Nonalcoholic Fatty Liver Disease Activity Score (NAS)	23.1 Percentage of Participants	45.2 Percentage of Participants	37.0 Percentage of Participants	32.0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 12, Week 52

Population: mITTb population: The mITTb population is defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 52/ET liver biopsies.

Alanine Aminotransferase (ALT) Relative (percent) change of from Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of alanine aminotransferase (ALT) is a marker of liver function improvement.

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=39 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=42 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=46 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=25 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Percent Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 and Week 52 Week 52	-28.60 percentage of change from Baseline Standard Error 5.044	-43.93 percentage of change from Baseline Standard Error 4.844	-40.60 percentage of change from Baseline Standard Error 4.682	-2.26 percentage of change from Baseline Standard Error 6.252
Percent Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 and Week 52 Week 12	-24.05 percentage of change from Baseline Standard Error 4.154	-32.92 percentage of change from Baseline Standard Error 4.075	-38.29 percentage of change from Baseline Standard Error 3.907	-9.57 percentage of change from Baseline Standard Error 5.034

SECONDARY outcome

Timeframe: Weeks 12, Week 52

Population: mITTb population: The mITTb population is defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 52/ET liver biopsies.

Relative (Percent) Change of Aspartate Aminotransferase (AST) From Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of Aspartate Aminotransferase (AST) is a marker of liver function improvement.

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=39 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=42 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=46 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=25 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Percent Change From Baseline in Aspartate Aminotransferase (AST) at Week 12 and Week 52 Week 12	-14.02 percentage of change from baseline Standard Error 4.793	-16.03 percentage of change from baseline Standard Error 4.686	-17.88 percentage of change from baseline Standard Error 4.491	-14.75 percentage of change from baseline Standard Error 5.834
Percent Change From Baseline in Aspartate Aminotransferase (AST) at Week 12 and Week 52 Week 52	-20.62 percentage of change from baseline Standard Error 5.988	-26.43 percentage of change from baseline Standard Error 5.698	-18.43 percentage of change from baseline Standard Error 5.536	-4.54 percentage of change from baseline Standard Error 7.490

SECONDARY outcome

Timeframe: Weeks 12, Week 52

Population: mITTb population: The mITTb population is defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 52/ET liver biopsies.

Relative (Percent) Change of Gamma Glutamyl Transferase (GGT) From Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of Gamma Glutamyl Transferase (GGT) is a marker of liver function improvement.

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=39 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=42 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=46 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=25 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Percent Change From Baseline in Gamma Glutamyl Transferase (GGT) at Week 12 and Week 52 Week 12	-28.67 Percentage of change from Baseline Standard Error 3.848	-37.78 Percentage of change from Baseline Standard Error 3.760	-42.50 Percentage of change from Baseline Standard Error 3.626	-6.40 Percentage of change from Baseline Standard Error 4.630
Percent Change From Baseline in Gamma Glutamyl Transferase (GGT) at Week 12 and Week 52 Week 52	-27.93 Percentage of change from Baseline Standard Error 5.674	-45.84 Percentage of change from Baseline Standard Error 5.401	-35.11 Percentage of change from Baseline Standard Error 5.255	0.71 Percentage of change from Baseline Standard Error 7.093

SECONDARY outcome

Timeframe: Week 12, Week 52

Population: mITT Population: defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 12 MRI-PDFF

Number of Participants with a relative decrease in MRI-PDFF ≥30% (ie, percent change ≥ 30%) at Weeks 12, and 52/ET (Early Termination) in the DB phase - mITT Population. MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration. MRI-PDFF response defined as ≥30% relative decline in MRI-PDFF is associated with ≥1 stage improvement in fibrosis and may be used as a surrogate marker of fibrosis regression in early phase clinical trials for NASH

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=50 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=47 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=48 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=26 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Number of Participants With Decrease in MRI-PDFF ≥ 30% From Baseline at Week 12 and Week 52 Week 12	12 Participants	12 Participants	9 Participants	8 Participants
Number of Participants With Decrease in MRI-PDFF ≥ 30% From Baseline at Week 12 and Week 52 Week 52/ET	8 Participants	19 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 52

Population: mITT Population: defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 12 MRI-PDFF

Percentage Change from Baseline in MRI-PDFF to Weeks 52//ET - mITT Population MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration.

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=50 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=47 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=48 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=26 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 52	-9.76 percentage of change from Baseline Standard Deviation 27.323	-23.98 percentage of change from Baseline Standard Deviation 30.666	-7.99 percentage of change from Baseline Standard Deviation 30.650	-18.30 percentage of change from Baseline Standard Deviation 27.872

SECONDARY outcome

Timeframe: Week 52

Population: mITTb population: The mITTb population is defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 52/ET liver biopsies.

Liver Biopsy Responders with reversal of NASH (ballooning score of 0 and lobular inflammation score of 0 or 1 and no worsening of hepatic fibrosis) at Week 52/ET. The reversal of NASH was defined as the absence of hepatocellular ballooning (score of 0) and no or minimal inflammation (lobular inflammation score of 0 or 1).

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=39 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=42 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=46 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=25 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Number of Liver Biopsy Responders With Reversal of NASH Reversal of NASH (Ballooning Score of 0 and Lobular Inflammation Score of 0 or 1) and no Worsening of Hepatic Fibrosis at Week 52	4 Participants	8 Participants	12 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 52

Population: mITTb population: The mITTb population is defined as any subject who is randomized, receives at least one dose of study drug, and has Baseline and Week 52/ET liver biopsies.

Proportion of subjects with improvement by at least 1 stage in fibrosis without worsening of NASH (ie, improvement by at least 1 fibrosis stage without worsening of NAS) at Week 52/ET - Cochran-Mantel-Haenszel - mITTb Population There five liver fibrosis stages (F0: no scarring (no fibrosis); F1: minimal scarring; F2: scarring has occurred and extends outside the liver area (significant fibrosis); F3: fibrosis spreading and forming bridges with other fibrotic liver areas (severe fibrosis); F4: cirrhosis or advanced scarring)

Outcome measures

Outcome measures
Measure	Seladelpar 10 mg n=39 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 20 mg n=42 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Seladelpar 50 mg n=46 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Seladelpar: 10 mg, 20 mg, or 50 mg	Placebo n=25 Participants Subjects were randomized to receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks. Placebos: Matching placebo Capsule
Percentage of Participants With Improvement by at Least 1 Stage in Fibrosis From Baseline at Week 12 and Week 52	9 Participants	10 Participants	17 Participants	5 Participants

Adverse Events

Seladelpar 10 mg

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

Seladelpar 20 mg

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Seladelpar 50 mg

Serious events: 5 serious events

Other events: 48 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Seladelpar 10 mg n=53 participants at risk Subjects were randomized to receive seladelpar 10 mg daily for 52 weeks. AEs are only summarized in DB phase, not OLE phase.	Seladelpar 20 mg n=51 participants at risk Subjects were randomized to receive seladelpar 20 mg daily for 52 weeks. AEs are only summarized in DB phase, not OLE phase.	Seladelpar 50 mg n=50 participants at risk Subjects were randomized to receive seladelpar 50 mg daily for 52 weeks. AEs are only summarized in DB phase, not OLE phase.	Placebo n=27 participants at risk Subjects were randomized to receive placebo daily for 52 weeks. AEs are only summarized in DB phase, not OLE phase.
Gastrointestinal disorders Faeces discoloured	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/51 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/50 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/51 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/50 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
General disorders Non-cardiac chest pain	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/51 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/50 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Infections and infestations Diverticulitis	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/51 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	4.0% 2/50 • Number of events 2 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/51 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/50 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Infections and infestations Pneumonia	1.9% 1/53 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/51 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/50 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/51 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/50 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Injury, poisoning and procedural complications Post procedural complication	1.9% 1/53 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/51 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/50 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/51 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/50 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.
Nervous system disorders Dizziness	0.00% 0/53 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	2.0% 1/51 • Number of events 1 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/50 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.	0.00% 0/27 • Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.

Other adverse events

Additional Information

Barry Crittenden, Vice President of Clinical Development

CymaBay Therapeutics, Inc.

Phone: 510-293-8800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place