Nonalcoholic Steatohepatitis (NASH)
Conditions
Brief summary
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
Interventions
BIOLOGICALNGM282
OTHERPlacebo
Sponsors
NGM Biopharmaceuticals Australia Pty Ltd
NGM Biopharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males or females, between 18 and 75 years of age, inclusive * Histologically confirmed NASH diagnosis
Exclusion criteria
* Clinically significant acute or chronic liver disease * Prior liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Absolute Liver Fat Content (Part 1) | Up to Week 12 | Absolute liver fat content was assessed using magnetic resonance imaging (MRI). |
| Change in Absolute Liver Fat Content (Part 2) | Up to Week 12 | Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Change in Absolute Liver Fat Content (Part 3) | Up to Week 24 | Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Absolute Liver Fat Content (Part 3) | Up to Week 30 | Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Percentage Change in Liver Fat Content (Part 1) | Up to Week 12 | Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI). |
| Percentage Change in Liver Fat Content (Part 3) | Up to Week 30 | Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Change in Absolute Liver Fat Content (Part 2) | Up to Week 18 | Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Percentage Change in Liver Fat Content (Part 2) | Up to Week 18 | Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
Countries
Australia, Puerto Rico, United States
Participant flow
Recruitment details
A total of 254 participants who met all inclusion criteria and no exclusion criteria were enrolled in this study. This was a 3-part study where Parts 1 and 3 were randomized, placebo controlled studies and Part 2 was an open-label study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Aldafermin 3.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home. | 27 |
| Part 1: Aldafermin 6.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home. | 28 |
| Part 1: Placebo Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home. | 27 |
| Part 2: Aldafermin 0.3 mg Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home. | 23 |
| Part 2: Aldafermin 1.0 mg Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home. | 21 |
| Part 2: Aldafermin 3.0 mg Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home. | 22 |
| Part 2: Aldafermin 1.0 mg (Cohort 4) Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home. | 28 |
| Part 3: Aldafermin 1.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 6, 8, 12, 18, and 24 were self-administered in the clinic, with all other doses throughout the treatment period self-administered at home. | 53 |
| Part 3: Placebo Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 6, 8, 12, 18, and 24 were self-administered in the clinic, with all other doses throughout the treatment period self-administered at home. | 25 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 | Adverse Event | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 | Lost to Follow-up | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 | Participant enrolled in another clinical trial | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 | Participant moved out of state | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 | Withdrew informed consent | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2 | Adverse Event | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 0 |
| Part 2 | Early end of treatment secondary to cardiac arrest and subsequently lost to follow up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Part 2 | Inability to comply with protocol | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part 2 | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part 2 | Withdrew informed consent | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Part 3 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part 3 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Part 3 | Withdrew informed consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | Part 1: Aldafermin 6.0 mg | Part 1: Placebo | Part 2: Aldafermin 0.3 mg | Part 2: Aldafermin 1.0 mg | Part 2: Aldafermin 3.0 mg | Part 1: Aldafermin 3.0 mg | Part 2: Aldafermin 1.0 mg (Cohort 4) | Part 3: Aldafermin 1.0 mg | Part 3: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 1 Participants | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 8 Participants | 2 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 23 Participants | 22 Participants | 17 Participants | 18 Participants | 26 Participants | 26 Participants | 45 Participants | 23 Participants | 226 Participants |
| Age, Continuous | 56.4 years STANDARD_DEVIATION 7.8 | 52.8 years STANDARD_DEVIATION 11.3 | 43.0 years STANDARD_DEVIATION 11.7 | 51.5 years STANDARD_DEVIATION 11.3 | 51.5 years STANDARD_DEVIATION 11.7 | 52.0 years STANDARD_DEVIATION 7.1 | 49.8 years STANDARD_DEVIATION 10 | 53.2 years STANDARD_DEVIATION 12.1 | 54.1 years STANDARD_DEVIATION 9.7 | 51.9 years STANDARD_DEVIATION 10.8 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 25 Participants | 23 Participants | 21 Participants | 22 Participants | 25 Participants | 26 Participants | 46 Participants | 22 Participants | 234 Participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 13 Participants | 18 Participants | 18 Participants | 16 Participants | 20 Participants | 26 Participants | 16 Participants | 163 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 10 Participants | 3 Participants | 4 Participants | 11 Participants | 8 Participants | 27 Participants | 9 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 | 0 / 27 | 0 / 23 | 0 / 21 | 0 / 22 | 0 / 28 | 0 / 53 | 0 / 25 |
| other Total, other adverse events | 26 / 27 | 27 / 28 | 23 / 27 | 20 / 23 | 19 / 21 | 21 / 22 | 27 / 28 | 46 / 53 | 22 / 25 |
| serious Total, serious adverse events | 1 / 27 | 0 / 28 | 0 / 27 | 0 / 23 | 1 / 21 | 4 / 22 | 1 / 28 | 2 / 53 | 3 / 25 |
Outcome results
Primary
Change in Absolute Liver Fat Content (Part 1)
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Time frame: Up to Week 12
Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 1) | -9.68 percent of liver fat | Standard Error 0.98 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 1) | -11.91 percent of liver fat | Standard Error 1 |
| Part 1: Placebo | Change in Absolute Liver Fat Content (Part 1) | -0.85 percent of liver fat | Standard Error 0.99 |
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: <0.00196% CI: [-12.09, -5.59]t-test, 2 sided
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: <0.00196% CI: [-14.39, -7.74]t-test, 2 sided
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: 0.11296% CI: [-5.11, 0.67]t-test, 2 sided
Primary
Change in Absolute Liver Fat Content (Part 2)
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 12
Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 2) | -4.95 percent of liver fat | Standard Error 1.07 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 2) | -10.69 percent of liver fat | Standard Error 1.09 |
| Part 1: Placebo | Change in Absolute Liver Fat Content (Part 2) | -11.55 percent of liver fat | Standard Error 1.08 |
| Part 2: Aldafermin 1.0 mg (Cohort 4) | Change in Absolute Liver Fat Content (Part 2) | -10.85 percent of liver fat | Standard Error 1.01 |
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: 0.613495% CI: [-2.05, 3.45]t-test, 2 sided
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: <0.000195% CI: [-8.48, -2.99]t-test, 2 sided
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: <0.000195% CI: [-9.41, -3.79]t-test, 2 sided
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: 0.546795% CI: [-3.71, 1.98]t-test, 2 sided
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: <0.000195% CI: [-8.55, -3.25]t-test, 2 sided
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: 0.903795% CI: [-2.89, 2.55]t-test, 2 sided
Primary
Change in Absolute Liver Fat Content (Part 3)
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 24
Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 3) | -7.70 percent of liver fat | Standard Error 0.82 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 3) | -2.73 percent of liver fat | Standard Error 1.29 |
Comparison: The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.p-value: 0.001895% CI: [-8.03, -1.91]t-test, 2 sided
Secondary
Change in Absolute Liver Fat Content (Part 2)
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 18
Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 2) | Week 18 | -4.51 percent of liver fat | Standard Error 1.17 |
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 2) | Week 6 | -4.15 percent of liver fat | Standard Error 0.93 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 2) | Week 6 | -8.21 percent of liver fat | Standard Error 0.97 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 2) | Week 18 | -3.87 percent of liver fat | Standard Error 1.14 |
| Part 1: Placebo | Change in Absolute Liver Fat Content (Part 2) | Week 18 | -7.67 percent of liver fat | Standard Error 1.15 |
| Part 1: Placebo | Change in Absolute Liver Fat Content (Part 2) | Week 6 | -10.38 percent of liver fat | Standard Error 0.94 |
| Part 2: Aldafermin 1.0 mg (Cohort 4) | Change in Absolute Liver Fat Content (Part 2) | Week 18 | -5.72 percent of liver fat | Standard Error 1.07 |
| Part 2: Aldafermin 1.0 mg (Cohort 4) | Change in Absolute Liver Fat Content (Part 2) | Week 6 | -8.36 percent of liver fat | Standard Error 0.87 |
Secondary
Change in Absolute Liver Fat Content (Part 3)
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 30
Population: Absolute liver fat content was assessed in the Efficacy Population in participants with available data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 3) | Week 6 | -6.54 percent of liver fat | Standard Error 0.59 |
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 3) | Week 12 | -8.43 percent of liver fat | Standard Error 0.74 |
| Part 1: Aldafermin 3.0 mg | Change in Absolute Liver Fat Content (Part 3) | Week 30 | -3.04 percent of liver fat | Standard Error 0.77 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 3) | Week 6 | -0.93 percent of liver fat | Standard Error 0.89 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 3) | Week 12 | -1.89 percent of liver fat | Standard Error 1.14 |
| Part 1: Aldafermin 6.0 mg | Change in Absolute Liver Fat Content (Part 3) | Week 30 | -2.05 percent of liver fat | Standard Error 1.19 |
Secondary
Percentage Change in Liver Fat Content (Part 1)
Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).
Time frame: Up to Week 12
Population: Percentage change in liver fat content was assessed in the Efficacy Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 1) | -47.98 percentage change of liver fat content | Standard Error 5.79 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 1) | -60.09 percentage change of liver fat content | Standard Error 5.92 |
| Part 1: Placebo | Percentage Change in Liver Fat Content (Part 1) | -2.57 percentage change of liver fat content | Standard Error 5.85 |
Secondary
Percentage Change in Liver Fat Content (Part 2)
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 18
Population: Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 2) | Week 6 | -24.95 percentage change of liver fat content | Standard Error 4.94 |
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 2) | Week 18 | -22.58 percentage change of liver fat content | Standard Error 6.66 |
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 2) | Week 12 | -29.09 percentage change of liver fat content | Standard Error 5.32 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 2) | Week 6 | -42.90 percentage change of liver fat content | Standard Error 5.19 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 2) | Week 18 | -17.70 percentage change of liver fat content | Standard Error 6.44 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 2) | Week 12 | -55.10 percentage change of liver fat content | Standard Error 5.42 |
| Part 1: Placebo | Percentage Change in Liver Fat Content (Part 2) | Week 12 | -63.84 percentage change of liver fat content | Standard Error 5.41 |
| Part 1: Placebo | Percentage Change in Liver Fat Content (Part 2) | Week 6 | -58.72 percentage change of liver fat content | Standard Error 5.01 |
| Part 1: Placebo | Percentage Change in Liver Fat Content (Part 2) | Week 18 | -40.79 percentage change of liver fat content | Standard Error 6.55 |
| Part 2: Aldafermin 1.0 mg (Cohort 4) | Percentage Change in Liver Fat Content (Part 2) | Week 6 | -45.92 percentage change of liver fat content | Standard Error 4.63 |
| Part 2: Aldafermin 1.0 mg (Cohort 4) | Percentage Change in Liver Fat Content (Part 2) | Week 18 | -29.03 percentage change of liver fat content | Standard Error 6.07 |
| Part 2: Aldafermin 1.0 mg (Cohort 4) | Percentage Change in Liver Fat Content (Part 2) | Week 12 | -57.85 percentage change of liver fat content | Standard Error 5.04 |
Secondary
Percentage Change in Liver Fat Content (Part 3)
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 30
Population: Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 6 | -36.59 percentage change of liver fat content | Standard Error 3.22 |
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 12 | -45.27 percentage change of liver fat content | Standard Error 4.26 |
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 24 | -38.76 percentage change of liver fat content | Standard Error 5.03 |
| Part 1: Aldafermin 3.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 30 | -11.22 percentage change of liver fat content | Standard Error 4.91 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 30 | -9.99 percentage change of liver fat content | Standard Error 7.59 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 6 | -2.17 percentage change of liver fat content | Standard Error 4.81 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 24 | -13.10 percentage change of liver fat content | Standard Error 7.89 |
| Part 1: Aldafermin 6.0 mg | Percentage Change in Liver Fat Content (Part 3) | Week 12 | -6.88 percentage change of liver fat content | Standard Error 6.6 |