Trial Outcomes & Findings for Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH) (NCT NCT03823703)
NCT ID: NCT03823703
Last Updated: 2022-08-31
Results Overview
The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: (\[Post-Baseline LFC-Baseline LFC\]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline and up to ~Day 95
Results posted on
2022-08-31
Participant Flow
Twelve adult patients with presumed NASH were enrolled in this study.
Participant milestones
| Measure |
Miricorilant- 900 mg
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
4
|
|
Overall Study
Treated
|
3
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
4
|
Reasons for withdrawal
| Measure |
Miricorilant- 900 mg
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Overall Study
Sponsor request
|
0
|
3
|
4
|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Miricorilant- 900 mg
n=3 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=5 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=4 Participants
Participants received 6 placebo tablets orally once daily.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 14.74 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 19.87 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 15.15 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 16.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Liver Fat Content (LFC) Assessed by MRI-PDFF
|
24.57 Percentage of liver fat content
STANDARD_DEVIATION 6.038 • n=5 Participants
|
15.70 Percentage of liver fat content
STANDARD_DEVIATION 6.536 • n=7 Participants
|
19.93 Percentage of liver fat content
STANDARD_DEVIATION 8.750 • n=5 Participants
|
19.33 Percentage of liver fat content
STANDARD_DEVIATION 7.526 • n=4 Participants
|
|
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) & Gamma Glutamyl Transferase (GGT)
AST
|
35.7 Units/Liter (U/L)
STANDARD_DEVIATION 8.14 • n=5 Participants
|
25.6 Units/Liter (U/L)
STANDARD_DEVIATION 12.76 • n=7 Participants
|
31 Units/Liter (U/L)
STANDARD_DEVIATION 4.08 • n=5 Participants
|
29.9 Units/Liter (U/L)
STANDARD_DEVIATION 9.68 • n=4 Participants
|
|
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) & Gamma Glutamyl Transferase (GGT)
ALT
|
52.3 Units/Liter (U/L)
STANDARD_DEVIATION 15.63 • n=5 Participants
|
33.2 Units/Liter (U/L)
STANDARD_DEVIATION 15.94 • n=7 Participants
|
54.0 Units/Liter (U/L)
STANDARD_DEVIATION 12.11 • n=5 Participants
|
44.9 Units/Liter (U/L)
STANDARD_DEVIATION 16.86 • n=4 Participants
|
|
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) & Gamma Glutamyl Transferase (GGT)
GGT
|
52.7 Units/Liter (U/L)
STANDARD_DEVIATION 19.63 • n=5 Participants
|
26.2 Units/Liter (U/L)
STANDARD_DEVIATION 9.20 • n=7 Participants
|
59.0 Units/Liter (U/L)
STANDARD_DEVIATION 50.29 • n=5 Participants
|
43.8 Units/Liter (U/L)
STANDARD_DEVIATION 32.20 • n=4 Participants
|
|
Propeptide of Type III Collagen (Pro-C3)
|
16.13 micrograms/liter (μg/L)
STANDARD_DEVIATION 5.350 • n=5 Participants
|
11.20 micrograms/liter (μg/L)
STANDARD_DEVIATION 2.189 • n=7 Participants
|
13.73 micrograms/liter (μg/L)
STANDARD_DEVIATION 4.727 • n=5 Participants
|
13.28 micrograms/liter (μg/L)
STANDARD_DEVIATION 4.159 • n=4 Participants
|
|
Enhanced Liver Fibrosis Score
|
9.713 ELF score
STANDARD_DEVIATION 1.011 • n=5 Participants
|
9.358 ELF score
STANDARD_DEVIATION 0.486 • n=7 Participants
|
9.330 ELF score
STANDARD_DEVIATION 0.805 • n=5 Participants
|
9.438 ELF score
STANDARD_DEVIATION 0.690 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to ~Day 95Population: The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.
The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: (\[Post-Baseline LFC-Baseline LFC\]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Outcome measures
| Measure |
Miricorilant- 900 mg
n=3 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=2 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
|
-50.28 Percent change
Standard Deviation 13.723
|
-22.94 Percent change
Standard Deviation 71.943
|
4.63 Percent change
Standard Deviation 5.232
|
SECONDARY outcome
Timeframe: Baseline and up to ~Day 95Population: The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.
The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of \<30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Outcome measures
| Measure |
Miricorilant- 900 mg
n=3 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=2 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF
Responders with a reduction in LFC from baseline of ≥30%
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF
Non-responders with a reduction in LFC from baseline of <30%
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The analysis population included all participants who were randomized to the study and had a post-baseline AST assessment.
The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Outcome measures
| Measure |
Miricorilant- 900 mg
n=1 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=1 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Change From Baseline in Aspartate Aminotransferase
|
346.0 units per liter (U/L)
Standard Deviation NA
No standard deviation because n=1.
|
321.0 units per liter (U/L)
Standard Deviation NA
No standard deviation because n=1.
|
-9.5 units per liter (U/L)
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The analysis population included all participants who were randomized to the study and had a post-baseline ALT assessment.
The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Outcome measures
| Measure |
Miricorilant- 900 mg
n=1 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=1 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Change From Baseline in Alanine Aminotransferase
|
810.0 U/L
Standard Deviation NA
No standard deviation because n=1.
|
826.0 U/L
Standard Deviation NA
No standard deviation because n=1.
|
-16 U/L
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The analysis population included all participants who were randomized to the study and had a post-baseline GGT assessment.
The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Outcome measures
| Measure |
Miricorilant- 900 mg
n=1 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=1 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Change From Baseline in Gamma-glutamyl Transferase
|
29.0 U/L
Standard Deviation NA
No standard deviation because n=1.
|
82.0 U/L
Standard Deviation NA
No standard deviation because n=1.
|
-26.0 U/L
Standard Deviation 31.11
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The analysis population included all participants who were randomized to the study and had a post-baseline pro-C3 assessment.
The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Outcome measures
| Measure |
Miricorilant- 900 mg
n=1 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Change From Baseline in Propeptide of Type III Collagen
|
4.0 μg/L
Standard Deviation NA
No standard deviation because n=1.
|
—
|
-1.65 μg/L
Standard Deviation 2.475
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The analysis population included all participants who were randomized to the study and had a post-baseline liver fibrosis assessment.
The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 \[TIMP-1\] and type III procollagen \[PIIINP\]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated \[ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)\], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.
Outcome measures
| Measure |
Miricorilant- 900 mg
n=1 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Change From Baseline in Enhanced Liver Fibrosis Score
|
1.050 ELF score
Standard Deviation NA
No standard deviation because n=1.
|
—
|
0.225 ELF score
Standard Deviation 0.459
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and up to ~Day 95Outcome measures
| Measure |
Miricorilant- 900 mg
n=3 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=2 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo
Responders
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo
Non-Responders
|
2 Participants
|
1 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and up to ~Day 95Outcome measures
| Measure |
Miricorilant- 900 mg
n=3 Participants
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=2 Participants
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=2 Participants
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo
Responders
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo
Non-Responders
|
3 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Miricorilant- 900 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Miricorilant- 600 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Miricorilant- 900 mg
n=3 participants at risk
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=5 participants at risk
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=4 participants at risk
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Hepatobiliary disorders
Drug-induced liver injury
|
66.7%
2/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Miricorilant- 900 mg
n=3 participants at risk
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
|
Miricorilant- 600 mg
n=5 participants at risk
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
|
Placebo
n=4 participants at risk
Participants received 6 placebo tablets orally once daily.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
66.7%
2/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
25.0%
1/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
40.0%
2/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Nervous system disorders
Depressed level of consciousness
|
33.3%
1/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
20.0%
1/5 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
0.00%
0/4 • Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
The analysis population included all patients who received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual publications will be allowed before publication of the multicenter results, except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.
- Publication restrictions are in place
Restriction type: OTHER