Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis (NCT NCT03421431)

Results Overview

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ALT level. Baseline refers to the average of the screening and the Day 1 values; if either the screening or Day 1 values were missing, the non-missing value was used. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

134 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2021-09-16

Participant Flow

The Safety or Efficacy Population consisted of all participants who received at least one dose of the study treatment. Out of 134 randomized participants, 2 participants (1 participant each in the EDP-305 2.5 mg and placebo groups) were randomized but not dosed because the participants withdrew and were not included in the Safety and Efficacy Populations.

Participant milestones

Participant milestones
Measure	Placebo A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Overall Study STARTED	24	55	53
Overall Study COMPLETED	18	49	39
Overall Study NOT COMPLETED	6	6	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Overall Study Adverse Event	2	1	12
Overall Study Lost to Follow-up	1	1	1
Overall Study Withdrawal by Subject	3	2	1
Overall Study Protocol Violation	0	1	0
Overall Study Participant met Stopping Rules	0	1	0

Baseline Characteristics

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=24 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=55 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=53 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	Total n=132 Participants Total of all reporting groups
Age, Customized <65 years	22 Participants n=93 Participants	52 Participants n=4 Participants	46 Participants n=27 Participants	120 Participants n=483 Participants
Age, Customized ≥65 years	2 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	12 Participants n=483 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	29 Participants n=4 Participants	29 Participants n=27 Participants	69 Participants n=483 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	26 Participants n=4 Participants	24 Participants n=27 Participants	63 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	7 Participants n=4 Participants	3 Participants n=27 Participants	11 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized White	17 Participants n=93 Participants	42 Participants n=4 Participants	47 Participants n=27 Participants	106 Participants n=483 Participants
Race/Ethnicity, Customized Not reported	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Mexican	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Race/Ethnicity, Customized Not specified	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ALT level. Baseline refers to the average of the screening and the Day 1 values; if either the screening or Day 1 values were missing, the non-missing value was used. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=48 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline (Average) in Alanine Aminotransferase (ALT) at Week 12	-13.85 units per liter (U/L) Standard Deviation 18.151	-23.76 units per liter (U/L) Standard Deviation 28.135	-26.14 units per liter (U/L) Standard Deviation 33.328

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=51 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=49 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12	-2.842 percentage of fat Standard Deviation 4.4687	-3.759 percentage of fat Standard Deviation 5.1600	-6.428 percentage of fat Standard Deviation 7.2586

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the aspartate aminotransferase (AST) level and platelet count. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. APRI is calculated from the level of AST measured in a blood test (international units per liter \[IU/L\]) and platelet count (10\^9/L) according to the following formula: APRI = (\[AST value in IU/L / upper limit of the normal range of AST\] / \[platelet count in 10\^9/L\]) × 100. In general, APRI scores range from 0 to \>2.0, where scores \<0.5 indicate no significant fibrosis, scores \>1.5 indicate significant fibrosis, and scores \>2.0 have been shown to be best correlated with the presence of cirrhosis. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=44 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=35 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Aspartate Aminotransferase to Platelet Ratio Index (APRI) at Week 12	-0.180 ratio Standard Deviation 0.3462	-0.107 ratio Standard Deviation 0.3396	-0.194 ratio Standard Deviation 0.3533

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the TG level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=48 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Triglycerides (TG) at Week 12	-0.151 millimoles per liter (mmol/L) Standard Deviation 0.8529	-0.366 millimoles per liter (mmol/L) Standard Deviation 1.5858	0.129 millimoles per liter (mmol/L) Standard Deviation 1.1088

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the total cholesterol level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=49 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Total Cholesterol at Week 12	-0.175 mmol/L Standard Deviation 0.6879	0.046 mmol/L Standard Deviation 0.6697	-0.003 mmol/L Standard Deviation 1.0046

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the HDL-C level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=49 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12	0.008 mmol/L Standard Deviation 0.1279	-0.058 mmol/L Standard Deviation 0.1670	-0.210 mmol/L Standard Deviation 0.2708

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the LDL-C level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=44 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=37 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	-0.112 mmol/L Standard Deviation 0.6431	0.129 mmol/L Standard Deviation 0.5099	0.151 mmol/L Standard Deviation 0.8157

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the adiponectin level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=48 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Adiponectin at Week 12	319.16 nanogram per milliliter (ng/mL) Standard Deviation 689.387	17.94 nanogram per milliliter (ng/mL) Standard Deviation 828.494	522.00 nanogram per milliliter (ng/mL) Standard Deviation 2649.701

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoA-1 level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=49 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Apolipoproteins A1 (ApoA-1) at Week 12	-0.074 proteins*10^9/L Standard Deviation 0.1514	-0.107 proteins*10^9/L Standard Deviation 0.1671	-0.226 proteins*10^9/L Standard Deviation 0.2197

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoB level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=49 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Apolipoproteins B (ApoB) at Week 12	-0.028 proteins*10^9/L Standard Deviation 0.1687	0.040 proteins*10^9/L Standard Deviation 0.1781	0.099 proteins*10^9/L Standard Deviation 0.2898

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoC3 level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=49 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Apolipoproteins C3 (ApoC3) at Week 12	-0.0094 proteins*10^9/L Standard Deviation 0.04388	-0.0167 proteins*10^9/L Standard Deviation 0.03918	-0.0122 proteins*10^9/L Standard Deviation 0.05721

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the fasting glucose level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=48 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Fasting Blood Glucose at Week 12	-0.11 mmol/L Standard Deviation 2.130	0.48 mmol/L Standard Deviation 1.847	1.68 mmol/L Standard Deviation 3.396

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the fasting insulin (in micro International units per milliliter \[μIU/mL\]). Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=47 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Fasting Insulin at Week 12	-0.688 μIU/mL Standard Deviation 9.2808	2.528 μIU/mL Standard Deviation 14.6947	-5.635 μIU/mL Standard Deviation 52.7637

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation; from the results of fasting glucose and insulin, an insulin resistance (IR) was estimated for the nondiabetic participants using the HOMA-IR computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Participants who were not considered as having type 2 diabetes mellitus (T2DM) were identified as nondiabetic. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=11 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=13 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Homeostasis Model Assessment (HOMA) Index for Nondiabetic Participants at Week 12	0.587 units on a scale Standard Deviation 2.0088	0.192 units on a scale Standard Deviation 2.7180	-6.474 units on a scale Standard Deviation 24.9369

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation; from the results of fasting glucose and insulin, an insulin resistance (IR) was estimated for the nondiabetic participants using the HOMA-IR computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Participants who were considered as having T2DM were identified as diabetic. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=35 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=25 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in HOMA Index for Diabetic Participants at Week 12	-0.493 units on a scale Standard Deviation 6.2624	2.088 units on a scale Standard Deviation 6.6114	5.059 units on a scale Standard Deviation 15.0113

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected at specific timepoints for the laboratory evaluation to assess the HbA1c. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=38 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=25 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) in Participants With T2DM at Week 12	0.31 percentage of glycated hemoglobin Standard Deviation 0.685	0.21 percentage of glycated hemoglobin Standard Deviation 0.776	0.76 percentage of glycated hemoglobin Standard Deviation 0.963

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Cmax is the maximum observed plasma concentration, which was measured for EDP-305 on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the Pharmacokinetic (PK) Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Maximum Plasma Concentration (Cmax) of EDP-305 on Day 1 and Week 12 Day 1	11.1 ng/mL Geometric Coefficient of Variation 105	25.1 ng/mL Geometric Coefficient of Variation 101	—
Maximum Plasma Concentration (Cmax) of EDP-305 on Day 1 and Week 12 Week 12	15.9 ng/mL Geometric Coefficient of Variation 105	41.1 ng/mL Geometric Coefficient of Variation 101	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Tmax was measured for EDP-305 on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) of EDP-305 on Day 1 and at Week 12 Day 1	6.00 hours (h) Interval 2.0 to 8.07	6.00 hours (h) Interval 2.0 to 8.25	—
Time to Reach Maximum Plasma Concentration (Tmax) of EDP-305 on Day 1 and at Week 12 Week 12	6.00 hours (h) Interval 0.0 to 8.02	6.00 hours (h) Interval 0.0 to 8.18	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EDP-305 on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[Last]) of EDP-305 on Day 1 and at Week 12 Day 1	53.6 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 101	129 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 100	—
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[Last]) of EDP-305 on Day 1 and at Week 12 Week 12	87.2 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 101	264 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 100	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Cmax is the maximum observed plasma concentration, which was measured for EP-022571 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Cmax of EP-022571 on Day 1 and at Week 12 Day 1	0.324 ng/mL Geometric Coefficient of Variation 983	0.833 ng/mL Geometric Coefficient of Variation 177	—
Cmax of EP-022571 on Day 1 and at Week 12 Week 12	0.296 ng/mL Geometric Coefficient of Variation 1549	0.787 ng/mL Geometric Coefficient of Variation 233	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Tmax was measured for EP-022571 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Tmax of EP-022571 on Day 1 and at Week 12 Day 1	6.00 h Interval 2.0 to 8.0	6.00 h Interval 1.93 to 8.25	—
Tmax of EP-022571 on Day 1 and at Week 12 Week 12	6.00 h Interval 0.0 to 8.0	6.00 h Interval 0.0 to 6.15	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022571 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
AUC(Last) of EP-022571 on Day 1 and at Week 12 Day 1	1.48 h*ng/mL Geometric Coefficient of Variation 174	3.77 h*ng/mL Geometric Coefficient of Variation 112	—
AUC(Last) of EP-022571 on Day 1 and at Week 12 Week 12	1.41 h*ng/mL Geometric Coefficient of Variation 187.01	3.81 h*ng/mL Geometric Coefficient of Variation 121.18	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Cmax is the maximum observed plasma concentration, which was measured for EP-022572 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Cmax of EP-022572 on Day 1 and at Week 12 Day 1	0.234 ng/mL Geometric Coefficient of Variation 1942	0.571 ng/mL Geometric Coefficient of Variation 212	—
Cmax of EP-022572 on Day 1 and at Week 12 Week 12	0.214 ng/mL Geometric Coefficient of Variation 2863	0.556 ng/mL Geometric Coefficient of Variation 212	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Tmax was measured for EP-022572 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Tmax of EP-022572 on Day 1 and at Week 12 Day 1	6.00 h Interval 2.0 to 8.07	6.00 h Interval 2.0 to 8.0	—
Tmax of EP-022572 on Day 1 and at Week 12 Week 12	6.00 h Interval 0.0 to 8.0	2.05 h Interval 0.0 to 8.18	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022572 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
AUC(Last) of EP-022572 on Day 1 and at Week 12 Day 1	1.06 h*ng/mL Geometric Coefficient of Variation 220	2.92 h*ng/mL Geometric Coefficient of Variation 114	—
AUC(Last) of EP-022572 on Day 1 and at Week 12 Week 12	1.13 h*ng/mL Geometric Coefficient of Variation 212	3.19 h*ng/mL Geometric Coefficient of Variation 116	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Cmax is the maximum observed plasma concentration, which was measured for EP-022679 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Cmax of EP-022679 on Day 1 and at Week 12 Day 1	0.574 ng/mL Geometric Coefficient of Variation 321	1.28 ng/mL Geometric Coefficient of Variation 167	—
Cmax of EP-022679 on Day 1 and at Week 12 Week 12	1.41 ng/mL Geometric Coefficient of Variation 117	3.85 ng/mL Geometric Coefficient of Variation 122	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

The Tmax was measured for EP-022679 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Tmax of EP-022679 on Day 1 and at Week 12 Day 1	8.00 h Interval 5.88 to 8.0	8.00 h Interval 6.0 to 8.25	—
Tmax of EP-022679 on Day 1 and at Week 12 Week 12	6.03 h Interval 0.0 to 8.0	6.00 h Interval 0.0 to 8.18	—

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)

Population: PK Population: included all participants who received active study drug (EDP-305) and had any measurable plasma concentration of study drug at any timepoint. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable for specified category.

AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022679 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=52 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
AUC(Last) of EP-022679 on Day 1 and at Week 12 Day 1	2.32 h*ng/mL Geometric Coefficient of Variation 137.54	5.09 h*ng/mL Geometric Coefficient of Variation 117	—
AUC(Last) of EP-022679 on Day 1 and at Week 12 Week 12	7.14 h*ng/mL Geometric Coefficient of Variation 113	22.5 h*ng/mL Geometric Coefficient of Variation 104	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Body weight was measured at specific timepoints for the participants. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=49 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Body Weight at Week 12	-0.877 kilograms (kg) Standard Deviation 2.8100	-1.440 kilograms (kg) Standard Deviation 2.7984	-2.114 kilograms (kg) Standard Deviation 3.2829

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

The WTH ratio is calculated as the ratio of waist to hip circumference, which was measured at specific timepoints. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=49 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=38 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Waist to Hip (WTH) Ratio at Week 12	0.013 ratio Standard Deviation 0.0729	-0.007 ratio Standard Deviation 0.0477	0.014 ratio Standard Deviation 0.0509

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and Day 84 (Week 12)

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: FGF19. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=18 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=14 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Fibroblast Growth Factor 19 (FGF19) by Nominal Timepoint (Intensive Pharmacodynamic [PD] Samples) at Week 12	159.98 nanogram per liter (ng/L) Standard Deviation 165.245	410.00 nanogram per liter (ng/L) Standard Deviation 260.223	607.12 nanogram per liter (ng/L) Standard Deviation 891.553

SECONDARY outcome

Timeframe: Predose and two samples postdose (first sample between 1 to 3 hours postdose and second sample 1 hour later than fist sample) on Day 1 and Day 84 (Week 12)

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: FGF19. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=23 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=17 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in FGF19 by Bin Timepoint (Sparse PD Samples) at Week 12	33.51 ng/L Standard Deviation 155.744	46.04 ng/L Standard Deviation 88.662	813.29 ng/L Standard Deviation 3200.567

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and Day 84 (Week 12)

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: C4. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=17 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=14 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in 7a-Hydroxy-4-Cholestene-3-One (C4) by Nominal Timepoint (Intensive PD Samples) at Week 12	-9.484 ng/mL Standard Deviation 20.6295	-36.783 ng/mL Standard Deviation 24.6560	-40.567 ng/mL Standard Deviation 20.9260

SECONDARY outcome

Timeframe: Predose and two samples postdose (first sample between 1 to 3 hours postdose and second sample 1 hour later than fist sample) on Day 1 and Day 84 (Week 12)

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: C4. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=25 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=18 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in C4 by Bin Timepoint (Sparse PD Samples) at Week 12	-5.242 ng/mL Standard Deviation 30.5321	-13.500 ng/mL Standard Deviation 26.2458	-23.773 ng/mL Standard Deviation 20.7045

SECONDARY outcome

Timeframe: Predose and 2, 6, and 8 hours postdose on Day 1 and Day 84 (Week 12)

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: BA. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=18 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=14 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in Bile Acid (BA) by Nominal Timepoint (Intensive PD Samples) at Week 12	4.47 micromoles per liter (μmol/L) Standard Deviation 3.668	2.16 micromoles per liter (μmol/L) Standard Deviation 5.507	0.14 micromoles per liter (μmol/L) Standard Deviation 3.125

SECONDARY outcome

Timeframe: Predose and two samples postdose (first sample between 1 to 3 hours postdose and second sample 1 hour later than fist sample) on Day 1 and Day 84 (Week 12)

Population: Efficacy Population: included all participants who received at least one dose of the study treatment. Here "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Only those participants with valid measurements for the outcome measure at the specified time point were reported.

Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: BA. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=25 Participants EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=17 Participants EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Mean Change From Baseline in BA by Bin Timepoint (Sparse PD Samples) at Week 12	0.77 μmol/L Standard Deviation 5.789	-0.11 μmol/L Standard Deviation 2.783	0.74 μmol/L Standard Deviation 4.091

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

EDP-305 1 mg

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

EDP-305 2.5 mg

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=24 participants at risk A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=55 participants at risk EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=53 participants at risk EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Nervous system disorders Cerebrovascular accident	4.2% 1/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	0.00% 0/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	0.00% 0/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.8% 1/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	0.00% 0/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.

Other adverse events

Other adverse events
Measure	Placebo n=24 participants at risk A matching placebo tablet (EDP-305 1 mg or 2.5 mg) was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks. The matching placebo contained all the excipients present in the EDP-305 drug product tablets with the exception of the active drug.	EDP-305 1 mg n=55 participants at risk EDP-305 1 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.	EDP-305 2.5 mg n=53 participants at risk EDP-305 2.5 mg tablet was administered orally once daily in the morning after fasting overnight for a minimum of 8 hours for 12 weeks.
Skin and subcutaneous tissue disorders Pruritus generalised	4.2% 1/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	9.1% 5/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	47.2% 25/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.8% 1/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	7.5% 4/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Skin and subcutaneous tissue disorders Pruritus	4.2% 1/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	0.00% 0/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	5.7% 3/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Gastrointestinal disorders Nausea	4.2% 1/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	5.5% 3/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	3.8% 2/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	3.6% 2/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	5.7% 3/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Gastrointestinal disorders Vomiting	8.3% 2/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.8% 1/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.9% 1/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Infections and infestations Urinary tract infection	0.00% 0/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	5.5% 3/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.9% 1/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Nervous system disorders Headache	8.3% 2/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	3.6% 2/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	3.8% 2/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Nervous system disorders Dizziness	4.2% 1/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	5.5% 3/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.9% 1/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	5.5% 3/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.9% 1/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
General disorders Fatigue	8.3% 2/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	3.6% 2/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	3.8% 2/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/24 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	1.8% 1/55 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.	5.7% 3/53 • Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's end of the study visit (Week 16). Ongoing AEs were followed beyond the end of the study visit at the discretion of the investigator. Treatment-emergent adverse events were summarized for the Safety Population, which included all the randomized participants who received at least one dose of the study treatment.

Additional Information

Kristin Sanderson

Enanta Pharmaceuticals

Phone: 617-607-0775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place