NASH - Nonalcoholic Steatohepatitis
Conditions
Brief summary
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
Interventions
BIOLOGICALNGM282
NGM282
OTHERPlacebo
Placebo for NGM282
Sponsors
NGM Biopharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed NASH diagnosis as defined by the NASH CRN 2. Total liver fat content of ≥ 8% as measured by MRI-PDFF
Exclusion criteria
1. Clinically significant acute or chronic liver disease of an etiology other than NASH 2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis 3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters 4. Prior or pending liver transplantation Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline up to Week 24 | Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared with baseline. |
| Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline up to Week 24 | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that commenced on or after the date and time of first study drug administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline, Week 12, Week 24, and Week 30 | Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). |
| Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline to Week 12, Week 24, and Week 30 | Change from baseline in liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Negative values indicate an improvement in liver fat content. |
| Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline to Week 12, Week 24 and Week 30 | Liver fat normalization (LFC; defined as \<5%) and response (LFC decrease \>=5% from baseline and LFC relative decrease \>=30% from baseline) were assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). The responders were defined as participants with either normalization (\<5%) or response (decrease from baseline \>=5% or relative decrease from baseline \>=30%). |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
A total of 171 participants who met all inclusion criteria and no exclusion criteria were randomized to receive treatment at 37 clinic sites in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Aldafermin 0.3 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg. | 43 |
| Aldafermin 1.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. | 42 |
| Aldafermin 3.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. | 43 |
| Placebo Participants who were randomized to receive a single subcutaneous injection of placebo. | 43 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 2 | 1 | 2 |
| Overall Study | Other | 0 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 9 Participants | 6 Participants | 7 Participants | 8 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 35 Participants | 36 Participants | 35 Participants | 140 Participants |
| Age, Continuous | 54.3 years STANDARD_DEVIATION 11.2 | 49.8 years STANDARD_DEVIATION 13.2 | 52.7 years STANDARD_DEVIATION 11.1 | 53.0 years STANDARD_DEVIATION 10.8 | 52.5 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 38 Participants | 39 Participants | 41 Participants | 158 Participants |
| Sex: Female, Male Female | 28 Participants | 29 Participants | 29 Participants | 26 Participants | 112 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 14 Participants | 17 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 1 / 41 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 30 / 43 | 34 / 41 | 38 / 43 | 36 / 43 |
| serious Total, serious adverse events | 1 / 43 | 4 / 41 | 1 / 43 | 3 / 43 |
Outcome results
Primary
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared with baseline.
Time frame: Baseline up to Week 24
Population: Liver fibrosis response was assessed in the Intent-to-Treat Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aldafermin 0.3 mg | Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | 0.24 score on a scale | Standard Error 0.04 |
| Aldafermin 1.0 mg | Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | 0.25 score on a scale | Standard Error 0.04 |
| Aldafermin 3.0 mg | Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | 0.27 score on a scale | Standard Error 0.07 |
| Placebo | Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | 0.23 score on a scale | Standard Error 0.06 |
p-value: 0.5534Multiple comparison procedure step
Primary
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that commenced on or after the date and time of first study drug administration.
Time frame: Baseline up to Week 24
Population: TEAEs were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE | 30 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 1 | 11 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 2 | 16 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 3 | 1 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 4 | 2 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 5 | 0 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE | 13 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to aldafermin | 17 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to aldafermin | 10 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to aldafermin | 2 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to aldafermin | 1 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE | 13 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to rosuvastatin | 17 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to rosuvastatin | 10 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to rosuvastatin | 1 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to rosuvastatin | 2 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE leading to study drug withdrawal | 3 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE leading to study drug withdrawal | 1 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE leading to study drug withdrawal | 2 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any serious TEAE | 1 Participants |
| Aldafermin 0.3 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAEs leading to death | 0 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE leading to study drug withdrawal | 1 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE | 34 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to aldafermin | 14 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE | 4 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE | 20 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to rosuvastatin | 2 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to rosuvastatin | 1 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to rosuvastatin | 30 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 2 | 18 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any serious TEAE | 4 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE leading to study drug withdrawal | 4 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to rosuvastatin | 1 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to aldafermin | 8 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 4 | 1 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 5 | 1 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAEs leading to death | 1 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to aldafermin | 5 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 3 | 2 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 1 | 12 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE leading to study drug withdrawal | 0 Participants |
| Aldafermin 1.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to aldafermin | 7 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 1 | 17 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 5 | 0 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE | 21 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE leading to study drug withdrawal | 1 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to aldafermin | 17 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to aldafermin | 7 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to aldafermin | 5 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to aldafermin | 9 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE leading to study drug withdrawal | 0 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE | 9 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to rosuvastatin | 29 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAEs leading to death | 0 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to rosuvastatin | 6 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to rosuvastatin | 3 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any serious TEAE | 1 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to rosuvastatin | 0 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE | 38 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 2 | 19 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE leading to study drug withdrawal | 3 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 3 | 2 Participants |
| Aldafermin 3.0 mg | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 4 | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to rosuvastatin | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, definite related to aldafermin | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE leading to study drug withdrawal | 3 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE | 36 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any serious TEAE | 3 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to aldafermin | 2 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to aldafermin | 11 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 1 | 10 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE leading to study drug withdrawal | 2 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to aldafermin | 22 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 5 | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 2 | 24 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAEs leading to death | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, possible related to rosuvastatin | 6 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, not related to rosuvastatin | 28 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE leading to study drug withdrawal | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any aldafermin-related TEAE | 14 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, probable related to rosuvastatin | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 4 | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any rosuvastatin-related TEAE | 8 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Any TEAE, Grade 3 | 1 Participants |
Secondary
Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Change from baseline in liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Negative values indicate an improvement in liver fat content.
Time frame: Baseline to Week 12, Week 24, and Week 30
Population: Mean change from baseline in liver fat content was assessed in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aldafermin 0.3 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 12 | -4.28 percentage of liver fat content | Standard Error 0.83 |
| Aldafermin 0.3 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Mean change from baseline to Week 30 | -2.10 percentage of liver fat content | Standard Error 1.08 |
| Aldafermin 0.3 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 24 | -3.73 percentage of liver fat content | Standard Error 0.97 |
| Aldafermin 1.0 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 12 | -7.50 percentage of liver fat content | Standard Error 0.85 |
| Aldafermin 1.0 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Mean change from baseline to Week 30 | -2.95 percentage of liver fat content | Standard Error 1.13 |
| Aldafermin 1.0 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 24 | -7.35 percentage of liver fat content | Standard Error 1.04 |
| Aldafermin 3.0 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 24 | -11.37 percentage of liver fat content | Standard Error 0.98 |
| Aldafermin 3.0 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 12 | -11.37 percentage of liver fat content | Standard Error 0.84 |
| Aldafermin 3.0 mg | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Mean change from baseline to Week 30 | -5.19 percentage of liver fat content | Standard Error 1.05 |
| Placebo | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 12 | -1.49 percentage of liver fat content | Standard Error 0.82 |
| Placebo | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Mean change from baseline to Week 30 | -2.92 percentage of liver fat content | Standard Error 1.05 |
| Placebo | Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Change from baseline to Week 24 | -3.44 percentage of liver fat content | Standard Error 0.98 |
Secondary
Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).
Time frame: Baseline, Week 12, Week 24, and Week 30
Population: Mean change in liver fat content was assessed in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aldafermin 0.3 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline | 19.13 percentage of liver fat content | Standard Deviation 7.6 |
| Aldafermin 0.3 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12 | 14.43 percentage of liver fat content | Standard Deviation 8.8 |
| Aldafermin 0.3 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30 | 16.30 percentage of liver fat content | Standard Deviation 9.2 |
| Aldafermin 0.3 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24 | 14.85 percentage of liver fat content | Standard Deviation 9.3 |
| Aldafermin 1.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline | 17.40 percentage of liver fat content | Standard Deviation 6.4 |
| Aldafermin 1.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30 | 15.36 percentage of liver fat content | Standard Deviation 6.5 |
| Aldafermin 1.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12 | 10.62 percentage of liver fat content | Standard Deviation 5.6 |
| Aldafermin 1.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24 | 10.64 percentage of liver fat content | Standard Deviation 6.2 |
| Aldafermin 3.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline | 18.69 percentage of liver fat content | Standard Deviation 7.5 |
| Aldafermin 3.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30 | 13.10 percentage of liver fat content | Standard Deviation 7.4 |
| Aldafermin 3.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24 | 6.72 percentage of liver fat content | Standard Deviation 5.6 |
| Aldafermin 3.0 mg | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12 | 7.03 percentage of liver fat content | Standard Deviation 5.7 |
| Placebo | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30 | 14.27 percentage of liver fat content | Standard Deviation 7.5 |
| Placebo | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Baseline | 17.00 percentage of liver fat content | Standard Deviation 6.6 |
| Placebo | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24 | 14.01 percentage of liver fat content | Standard Deviation 6.2 |
| Placebo | Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12 | 16.00 percentage of liver fat content | Standard Deviation 7.1 |
Secondary
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Liver fat normalization (LFC; defined as \<5%) and response (LFC decrease \>=5% from baseline and LFC relative decrease \>=30% from baseline) were assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). The responders were defined as participants with either normalization (\<5%) or response (decrease from baseline \>=5% or relative decrease from baseline \>=30%).
Time frame: Baseline to Week 12, Week 24 and Week 30
Population: Liver fat content normalization and response were assessed in participants with available data in the Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, response | 3 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, No response | 16 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, Response | 21 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, No response | 19 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, No response | 24 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, No response | 33 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, No response | 26 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, Response | 8 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, Response | 19 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, Response | 10 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, No response | 30 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, response | 4 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, No response | 19 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, No response | 35 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, No response | 19 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, Response | 18 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, Response | 19 Participants |
| Aldafermin 0.3 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, response | 4 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, Response | 25 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, response | 4 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, No response | 33 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, Response | 24 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, No response | 13 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, No response | 12 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, response | 4 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, No response | 29 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, Response | 21 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, No response | 12 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, Response | 20 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, No response | 13 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, response | 1 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, No response | 30 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, Response | 12 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, No response | 19 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, Response | 11 Participants |
| Aldafermin 1.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, No response | 20 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, Response | 33 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, No response | 7 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, Response | 32 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, No response | 4 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, No response | 20 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, No response | 5 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, Response | 16 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, response | 4 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, Response | 33 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, No response | 32 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, response | 17 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, Response | 15 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, No response | 20 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, response | 20 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, No response | 4 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, No response | 17 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, No response | 21 Participants |
| Aldafermin 3.0 mg | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, Response | 30 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, response | 2 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, No response | 27 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, No response | 32 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, No response | 27 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, No response | 32 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, response | 0 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Normalization, No response | 39 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, Response | 11 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, Response | 7 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, No response | 26 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Decrease >=5%, Response | 9 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Relative decrease >=30%, No response | 26 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Decrease >=5%, Response | 7 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 12: Relative decrease >=30%, No response | 32 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Decrease >=5%, Response | 10 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Normalization, response | 4 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 24: Normalization, No response | 35 Participants |
| Placebo | Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | Week 30: Relative decrease >=30%, Response | 10 Participants |