Trial Outcomes & Findings for Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH) (NCT NCT02912260)
NCT ID: NCT02912260
Last Updated: 2025-12-23
Results Overview
The primary endpoint was relative change in MRI-PDFF assessed hepatic fat fraction compared with placebo at Week 12 in participants who had both a baseline and Week 12 MRI-PDFF. Least squares (LS) mean was provided for the statistical comparison of MGL-3196 versus placebo.
COMPLETED
PHASE2
125 participants
Week 12
2025-12-23
Participant Flow
Participants underwent screening procedures within 42 days of randomization. To participate in the study, participants were required to have had a qualifying liver biopsy within 180 days of randomization.
Participant milestones
| Measure |
MGL-3196
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Main Study
STARTED
|
84
|
41
|
|
Main Study
Received at Least 1 Dose of Study Drug
|
84
|
41
|
|
Main Study
COMPLETED
|
74
|
34
|
|
Main Study
NOT COMPLETED
|
10
|
7
|
|
Extension Study
STARTED
|
17
|
14
|
|
Extension Study
COMPLETED
|
16
|
13
|
|
Extension Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
MGL-3196
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Main Study
Lost to Follow-up
|
5
|
4
|
|
Main Study
Withdrawal by Subject
|
2
|
2
|
|
Main Study
Adverse Event
|
3
|
0
|
|
Main Study
Physician Decision
|
0
|
1
|
|
Extension Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
MGL-3196
n=84 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=41 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 10.35 • n=9 Participants
|
47.3 years
STANDARD_DEVIATION 11.71 • n=6 Participants
|
50.3 years
STANDARD_DEVIATION 10.97 • n=9 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=9 Participants
|
17 Participants
n=6 Participants
|
63 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=9 Participants
|
24 Participants
n=6 Participants
|
62 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
59 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
66 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=9 Participants
|
37 Participants
n=6 Participants
|
117 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Hepatic Fat Fraction by MRI-PDFF at Screening
|
20.25 percentage
STANDARD_DEVIATION 6.843 • n=9 Participants
|
19.63 percentage
STANDARD_DEVIATION 8.159 • n=6 Participants
|
20.05 percentage
STANDARD_DEVIATION 7.274 • n=9 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.
The primary endpoint was relative change in MRI-PDFF assessed hepatic fat fraction compared with placebo at Week 12 in participants who had both a baseline and Week 12 MRI-PDFF. Least squares (LS) mean was provided for the statistical comparison of MGL-3196 versus placebo.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
|
-32.9 percent change
Standard Error 3.0
|
-10.4 percent change
Standard Error 4.3
|
SECONDARY outcome
Timeframe: Week 12 and Week 36Population: Safety population: all randomized participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
MGL-3196
n=84 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=41 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants With Adverse Events (AEs)
Week 12
|
71.4 percentage of participants
|
46.3 percentage of participants
|
|
Percentage Of Participants With Adverse Events (AEs)
Week 36
|
86.9 percentage of participants
|
68.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: Modified Intent-to-Treat (mITT) population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The endpoint was relative change assessed hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the statistical comparison of MGL-3196 versus placebo.
Outcome measures
| Measure |
MGL-3196
n=74 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF
|
-37.3 percent change
Standard Error 3.7
|
-8.9 percent change
Standard Error 5.4
|
SECONDARY outcome
Timeframe: Week 12Population: MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.
The endpoint was change in MRI-PDFF assessed absolute hepatic fat fraction compared with placebo at Week 12. LS mean was provided for the comparison of MGL-3196 versus placebo.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF
|
-7.0 percentage
Standard Error 0.6
|
-2.7 percentage
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The endpoint was change in assessed absolute hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the comparison of MGL-3196 versus placebo.
Outcome measures
| Measure |
MGL-3196
n=74 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 36 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF
|
-8.2 percentage
Standard Error 0.7
|
-2.9 percentage
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Week 12Population: MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.
The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 12.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants With At Least 30% Relative Fat Reduction at Week 12
|
60.3 percentage of participants
|
18.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 36.
Outcome measures
| Measure |
MGL-3196
n=74 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants With At Least 30% Relative Fat Reduction At Week 36
|
67.6 percentage of participants
|
29.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The NAS is a histologic scale for non-alcoholic steatohepatitis (NASH) activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 1-point or greater reduction in NAS.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants Achieving A 1-Point Reduction In Non-alcoholic Fatty Liver Disease Activity Score (NAS) At Week 36
|
76.7 percentage of participants
|
64.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants Achieving A 2-Point Reduction In NAS At Week 36
|
56.2 percentage of participants
|
32.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS and a 1-point or greater reduction in lobular inflammation or hepatocellular ballooning.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants Achieving A 2-Point Reduction In NAS And Either A ≥1-Point Reduction In Lobular Inflammation Or Hepatocellular Ballooning At Week 36
|
50.7 percentage of participants
|
32.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). Fibrosis stage (0 to 3) was also included in the assessment. The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS without worsening fibrosis.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants Achieving A 2-Point Reduction In NAS Without Fibrosis Worsening At Week 36
|
45.2 percentage of participants
|
32.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular steatosis.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants With A Reduction In Hepatocellular Steatosis At Week 36
|
61.6 percentage of participants
|
44.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in lobular inflammation.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants With A Reduction In Lobular Inflammation At Week 36
|
21.9 percentage of participants
|
17.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular ballooning.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants With A Reduction In Hepatocellular Ballooning At Week 36
|
58.9 percentage of participants
|
58.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The endpoint presented the percentage of participants achieving NASH resolution with a 2-point reduction at Week 36.
Outcome measures
| Measure |
MGL-3196
n=73 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percentage Of Participants Achieving NASH Resolution With At Least 2-Point Reduction In NAS At Week 36
|
27.4 percentage of participants
|
14.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 12 In High-sensitivity C-reactive Protein (hsCRP)
|
29.3 percent change
Standard Error 18.36
|
13.2 percent change
Standard Error 25.97
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 36 In hsCRP
|
90.9 percent change
Standard Error 67.52
|
34.0 percent change
Standard Error 96.88
|
SECONDARY outcome
Timeframe: Week 12Population: MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.
Blood samples were collected to determine the effect of MGL-3196 on serum ALT.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 12 In Serum Alanine Aminotransferase (ALT)
|
-8.2 IU/L
Standard Error 2.7
|
-5.2 IU/L
Standard Error 3.9
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits
Blood samples were collected to determine the effect of MGL-3196 on serum ALT.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=37 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 36 In ALT
|
-15.4 IU/L
Standard Error 4.7
|
11.0 IU/L
Standard Error 6.8
|
SECONDARY outcome
Timeframe: Week 12Population: MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.
Blood samples were collected to determine the effect of MGL-3196 on serum AST.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 12 In Serum Aspartate Aminotransferase (AST)
|
-5.8 IU/L
Standard Error 1.8
|
-1.1 IU/L
Standard Error 2.5
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
Blood samples were collected to determine the effect of MGL-3196 on serum AST.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=37 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 36 In AST
|
-7.4 IU/L
Standard Error 1.9
|
3.6 IU/L
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Week 12Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
Blood samples were collected to determine the effect of MGL-3196 on lipid parameters including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol (TC), triglycerides (TG), apolipoprotein B (ApoB), and Apolipoprotein CIII (ApoCIII).
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
LDL-C
|
-10.6 percent change
Standard Error 1.96
|
2.2 percent change
Standard Error 2.79
|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
HDL-C
|
5.0 percent change
Standard Error 1.91
|
1.8 percent change
Standard Error 2.72
|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
non-HDL-C
|
-12.1 percent change
Standard Error 1.74
|
1.2 percent change
Standard Error 2.47
|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
TC
|
-8.7 percent change
Standard Error 1.37
|
0.9 percent change
Standard Error 1.95
|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
TG
|
-6.8 percent change
Standard Error 4.23
|
9.8 percent change
Standard Error 6.01
|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
ApoB
|
-14.5 percent change
Standard Error 1.59
|
0.8 percent change
Standard Error 2.25
|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
ApoCIII
|
-9.1 percent change
Standard Error 3.23
|
8.7 percent change
Standard Error 4.62
|
|
Percent Change From Baseline To Week 12 In Lipid Parameters
Lp(a)
|
-8.6 percent change
Standard Error 7.54
|
12.3 percent change
Standard Error 10.67
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits
Blood samples were collected to determine the effect of MGL-3196 on lipid parameters including LDL-C, HDL-C, non-HDL-C, TC, TG, ApoB, and ApoCIII.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
LDL-C
|
-11.0 percent change
Standard Error 2.14
|
1.5 percent change
Standard Error 3.11
|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
HDL-C
|
10.5 percent change
Standard Error 3.72
|
12.0 percent change
Standard Error 5.41
|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
non-HDL-C
|
-14.0 percent change
Standard Error 1.90
|
2.1 percent change
Standard Error 2.76
|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
TC
|
-8.9 percent change
Standard Error 1.61
|
3.6 percent change
Standard Error 2.34
|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
TG
|
-19.8 percent change
Standard Error 4.29
|
17.5 percent change
Standard Error 6.24
|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
ApoB
|
-16.5 percent change
Standard Error 1.79
|
0.9 percent change
Standard Error 2.58
|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
ApoCIII
|
-12.0 percent change
Standard Error 3.72
|
24.5 percent change
Standard Error 5.42
|
|
Percent Change From Baseline To Week 36 In Lipid Parameters
Lp(a)
|
19.0 percent change
Standard Error 10.95
|
39.0 percent change
Standard Error 15.82
|
SECONDARY outcome
Timeframe: Week 12Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
Blood samples were collected to determine the effect of MGL-3196 on lipid parameter Lp(a).
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 12 In Lipid Parameter Lipoprotein(a) (Lp[a])
|
-8.6 percent change
Standard Error 7.54
|
12.3 percent change
Standard Error 10.67
|
SECONDARY outcome
Timeframe: Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
Blood samples were collected to determine the effect of MGL-3196 on lipid parameter Lp(a).
Outcome measures
| Measure |
MGL-3196
n=71 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=34 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Percent Change From Baseline To Week 36 In Lipid Parameter Lp[a]
|
19.0 percent change
Standard Error 10.95
|
39.0 percent change
Standard Error 15.82
|
SECONDARY outcome
Timeframe: Week 12 and Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
Serum CK-18 fragments, detected using the M30 antibody, is a non-invasive biomarker for NASH that may reflect hepatocyte apoptosis.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=37 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 12 And Week 36 In Cytokeratin-18 (CK-18)
Week 12
|
-146.2 U/L
Standard Error 35
|
-87.5 U/L
Standard Error 51
|
|
Change From Baseline To Week 12 And Week 36 In Cytokeratin-18 (CK-18)
Week 36
|
-272.0 U/L
Standard Error 33
|
-101.0 U/L
Standard Error 47
|
SECONDARY outcome
Timeframe: Week 12 and Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The ELF Test is a non-invasive blood test that provides a simple, unitless numeric score that is used as a marker of collagen formation and fibrogenic activity and can be used to assess the risk of progression to cirrhosis. Scores below 9.8 indicate low risk of disease progression, and scores above 11.29 indicate high risk. The ELF score is derived from values of three serum biomarkers: hyaluronic acid (HA), procollagen III N-terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase-1 (TIMP-1). The formula is 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1); there are no minimum or maximum values.
Outcome measures
| Measure |
MGL-3196
n=40 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=21 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 12 And Week 36 In Enhanced Liver Fibrosis (ELF) Test
Week 12
|
-0.38 score on a scale
Standard Error 0.09
|
-0.02 score on a scale
Standard Error 0.12
|
|
Change From Baseline To Week 12 And Week 36 In Enhanced Liver Fibrosis (ELF) Test
Week 36
|
-0.66 score on a scale
Standard Error 0.12
|
-0.18 score on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 12 and Week 36Population: mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.
The Fib-4 score is a scoring system used to estimate the amount of scarring in the liver. It is based on common clinical parameters (age, AST, ALT, and platelets) and has been shown to have the best diagnostic accuracy for advanced fibrosis when compared with other noninvasive clinical scores. Scores are categorized into low (\<1.30), indeterminate (1.30-2.67), or high (\>2.67) risk of fibrosis. The formula for Fib-4 is: (Age \[yr\] x AST \[U/L\]) / ((PLT \[109/L\]) x (ALT \[U/L\])½); there are no minimum or maximum values
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline To Week 12 And Week 36 In Fibrosis-4 (Fib-4) Score
Week 12
|
-0.03 score on a scale
Standard Deviation 0.386
|
0.05 score on a scale
Standard Deviation 0.374
|
|
Change From Baseline To Week 12 And Week 36 In Fibrosis-4 (Fib-4) Score
Week 36
|
0.02 score on a scale
Standard Deviation 0.356
|
0.07 score on a scale
Standard Deviation 0.436
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Thyrotropin (TSH) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Thyrotropin at Week 12
|
0.096 mIU/L
Standard Deviation 0.9136
|
-0.101 mIU/L
Standard Deviation 0.9742
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Total thyroxine (FT4) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Total Thyroxine at Week 12
|
-1.18 μg/dL
Standard Deviation 0.958
|
-0.07 μg/dL
Standard Deviation 0.726
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Free thyroxine (FT4) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Free Thyroxine at Week 12
|
-0.147 ng/dL
Standard Deviation 0.1154
|
0.001 ng/dL
Standard Deviation 0.0930
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Total Triiodothyronine (T3) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Total Triiodothyronine at Week 12
|
0.03 μg/L
Standard Deviation 0.189
|
0.02 μg/L
Standard Deviation 0.236
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Free triiodothyronine (T3) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Free Triiodothyronine at Week 12
|
0.05 ng/L
Standard Deviation 0.363
|
-0.02 ng/L
Standard Deviation 0.513
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Thyroxine Binding Globulin was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Thyroxine Binding Globulin at Week 12
|
-1.42 mg/L
Standard Deviation 3.859
|
0.39 mg/L
Standard Deviation 3.522
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Reverse Triiodothyronine (T3) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=78 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=38 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Reverse Triiodothyronine Globulin at Week 12
|
-5.22 ng/dL
Standard Deviation 5.255
|
-0.96 ng/dL
Standard Deviation 5.757
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Tyrotropin (TSH) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Thyrotropin at Week 36
|
0.034 mIU/L
Standard Deviation 0.9705
|
0.043 mIU/L
Standard Deviation 0.9481
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Total thyroxine (FT4), thyrotropin (TSH) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Total Thyroxine at Week 36
|
-1.10 μg/dL
Standard Deviation 1.013
|
-0.17 μg/dL
Standard Deviation 0.846
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Total free thyroxine (FT4) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Free Thyroxine Week 36
|
-0.138 ng/dL
Standard Deviation 0.1280
|
-0.007 ng/dL
Standard Deviation 0.1162
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Total triiodothyronine (T3) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Total Triiodothyronine at Week 36
|
0.02 μg/L
Standard Deviation 0.212
|
-0.2 μg/L
Standard Deviation 0.190
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Free triiodothyronine (T3) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Free Triiodothyronine at Week 36
|
0.02 ng/L
Standard Deviation 0.404
|
-0.02 ng/L
Standard Deviation 0.475
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Thyroxine-binding globulin (TBG) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Thyroxine-Binding Globulin at Week 36
|
-0.38 mg/L
Standard Deviation 4.411
|
1.35 mg/L
Standard Deviation 5.639
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Reverse triiodothyronine (T3) was assessed at each study visit.
Outcome measures
| Measure |
MGL-3196
n=79 Participants
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo
n=39 Participants
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
|---|---|---|
|
Change From Baseline of Reverse Triiodothyronine at Week 36
|
-4.41 ng/dL
Standard Deviation 5.582
|
-1.04 ng/dL
Standard Deviation 5.493
|
Adverse Events
MGL-3196 Main Study
Placebo Main Study
Extension Study
Serious adverse events
| Measure |
MGL-3196 Main Study
n=84 participants at risk
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo Main Study
n=41 participants at risk
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
Extension Study
n=31 participants at risk
Patients randomized to MGL-3196 during the Main Study remained on the same dose of MGL-3196 or had a prespecified increase in dose upon entering the Extension Study. Former placebo patients were treated with 80 mg MGL-3196 initially, then up-titrated to 100 mg, remained on 80 mg, or had their dose reduced to 60 mg at Week 4 based on a PK sample obtained during Week 2.
|
|---|---|---|---|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/84 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
2.4%
1/41 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Hepatobiliary disorders
Bile duct stones
|
0.00%
0/84 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
2.4%
1/41 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.2%
1/84 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.2%
1/84 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.2%
1/84 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/84 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Renal and urinary disorders
Ureterolithiasis
|
1.2%
1/84 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
Other adverse events
| Measure |
MGL-3196 Main Study
n=84 participants at risk
Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.
|
Placebo Main Study
n=41 participants at risk
Randomized participants received matching placebo orally once daily in the morning for 36 weeks.
|
Extension Study
n=31 participants at risk
Patients randomized to MGL-3196 during the Main Study remained on the same dose of MGL-3196 or had a prespecified increase in dose upon entering the Extension Study. Former placebo patients were treated with 80 mg MGL-3196 initially, then up-titrated to 100 mg, remained on 80 mg, or had their dose reduced to 60 mg at Week 4 based on a PK sample obtained during Week 2.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
36.9%
31/84 • Number of events 49 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
9.8%
4/41 • Number of events 4 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
6.5%
2/31 • Number of events 6 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Gastrointestinal disorders
Nausea
|
20.2%
17/84 • Number of events 17 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
4.9%
2/41 • Number of events 2 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
6/84 • Number of events 8 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
7.3%
3/41 • Number of events 3 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.3%
7/84 • Number of events 9 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
2.4%
1/41 • Number of events 2 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Infections and infestations
Urinary tract infection
|
10.7%
9/84 • Number of events 10 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
9.8%
4/41 • Number of events 6 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
5/84 • Number of events 5 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
4.9%
2/41 • Number of events 3 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
9.7%
3/31 • Number of events 3 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Infections and infestations
Influenza
|
7.1%
6/84 • Number of events 6 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
5/84 • Number of events 5 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
4.9%
2/41 • Number of events 3 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
6/84 • Number of events 6 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
2.4%
1/41 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Nervous system disorders
Headache
|
13.1%
11/84 • Number of events 14 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
14.6%
6/41 • Number of events 7 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Nervous system disorders
Dizziness
|
7.1%
6/84 • Number of events 7 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
9.8%
4/41 • Number of events 4 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
General disorders
Fatigue
|
4.8%
4/84 • Number of events 5 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
9.8%
4/41 • Number of events 4 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.4%
2/84 • Number of events 2 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
7.3%
3/41 • Number of events 3 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Psychiatric disorders
Insomnia
|
6.0%
5/84 • Number of events 6 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
2.4%
1/41 • Number of events 1 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/31 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/84 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
6.5%
2/31 • Number of events 2 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/84 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
0.00%
0/41 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
6.5%
2/31 • Number of events 2 • Screening up to Week 36
Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release up to 45 days prior to submission and can embargo communications regarding study results for a period that is more than 90 days from the date that the communication is submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER