Trial Outcomes & Findings for ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD (NCT NCT02330549)
NCT ID: NCT02330549
Last Updated: 2019-10-11
Results Overview
Change in peripheral insulin sensitivity was measured by the Matsuda Index. Fasting plasma glucose (FPG) and fasting plasma insulin (FPI) concentrations measured during the oral glucose tolerance test (OGTT) were used to calculate the Matsuda Index. Matsuda Index=10,000/square root \[FPG mg/dL x FPI μIU/mL) x (mean glucose mg/dL x mean insulin μIU/mL during OGTT)\]. A Matsuda index of \<2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
COMPLETED
PHASE2
45 participants
Baseline (Day 1) to Weeks 12 and 24
2019-10-11
Participant Flow
Participant milestones
| Measure |
Cenicriviroc 150 mg
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
25
|
|
Overall Study
COMPLETED
|
16
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Cenicriviroc 150 mg
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Subject withdrew consent
|
2
|
1
|
|
Overall Study
Failure to meet randomization criteria
|
1
|
0
|
Baseline Characteristics
ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
Baseline characteristics by cohort
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 9.67 • n=39 Participants
|
51.0 years
STANDARD_DEVIATION 8.98 • n=41 Participants
|
52.2 years
STANDARD_DEVIATION 9.27 • n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: Intent to treat (ITT) population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Change in peripheral insulin sensitivity was measured by the Matsuda Index. Fasting plasma glucose (FPG) and fasting plasma insulin (FPI) concentrations measured during the oral glucose tolerance test (OGTT) were used to calculate the Matsuda Index. Matsuda Index=10,000/square root \[FPG mg/dL x FPI μIU/mL) x (mean glucose mg/dL x mean insulin μIU/mL during OGTT)\]. A Matsuda index of \<2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Matsuda Index
Change from Baseline to Week 24
|
0.03 unit on a scale
Standard Deviation 0.449
|
0.41 unit on a scale
Standard Deviation 0.674
|
|
Change From Baseline in Matsuda Index
Baseline
|
1.22 unit on a scale
Standard Deviation 0.661
|
1.04 unit on a scale
Standard Deviation 0.595
|
|
Change From Baseline in Matsuda Index
Change from Baseline to Week 12
|
-0.02 unit on a scale
Standard Deviation 0.348
|
0.24 unit on a scale
Standard Deviation 0.656
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Change in adipose insulin sensitivity was measured by Adipo-IR. Adipo-IR= (Fasting Serum free fatty acid (FFA) mmol/L x FPI μIU/mL). A higher Adipo-IR index indicates the worst disease state. A lower Adipo-IR Index is best. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index
Change from Baseline to Week 12
|
-1.41 unit on a scale
Standard Deviation 9.009
|
-0.52 unit on a scale
Standard Deviation 8.745
|
|
Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index
Change from Baseline to Week 24
|
-0.29 unit on a scale
Standard Deviation 7.524
|
-4.22 unit on a scale
Standard Deviation 11.612
|
|
Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index
Baseline
|
17.77 unit on a scale
Standard Deviation 14.074
|
17.74 unit on a scale
Standard Deviation 9.406
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Macrophage infiltration in adipose tissue was assessed in paraffin-embedded adipose punch biopsies by immunohistochemistry stained for cluster of differentiation 68 (CD68), cluster of differentiation 163 (CD163), C-C chemokine receptor type 2 (CCR2), C-C chemokine receptor type 5 (CCR5) and cluster of differentiation 206 (CD206). A reduction in infiltration indicates less inflammation. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=16 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=24 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CCR2+, Change from BL to Week 24
|
0.0 cells/μL
Interval -2.5 to 8.0
|
2.0 cells/μL
Interval -3.5 to 6.0
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CD206+, Baseline
|
6.0 cells/μL
Interval 4.0 to 10.5
|
7.0 cells/μL
Interval 5.0 to 9.0
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CD68+, Baseline
|
4.0 cells/μL
Interval 2.0 to 5.0
|
3.0 cells/μL
Interval 1.5 to 4.0
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CD68+, Change from BL to Week 24
|
1.0 cells/μL
Interval -1.5 to 3.0
|
1.0 cells/μL
Interval -0.5 to 1.5
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CD163+, Baseline
|
9.5 cells/μL
Interval 7.5 to 11.5
|
10.5 cells/μL
Interval 7.0 to 19.0
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CD163+, Change from BL at Week 24
|
2.0 cells/μL
Interval -1.0 to 6.5
|
1.0 cells/μL
Interval -3.5 to 4.0
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CCR2+, Baseline
|
10.0 cells/μL
Interval 6.0 to 13.5
|
10.5 cells/μL
Interval 7.0 to 17.0
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CCR5+, Baseline
|
3.0 cells/μL
Interval 2.0 to 4.0
|
3.0 cells/μL
Interval 1.5 to 5.0
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CCR5+, Change from BL to Week 24
|
1.0 cells/μL
Interval -1.0 to 2.0
|
0.0 cells/μL
Interval -1.5 to 1.5
|
|
Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue
CD206+, Change from BL to Week 24
|
0.0 cells/μL
Interval -3.5 to 2.0
|
-0.5 cells/μL
Interval -2.5 to 2.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available at the given timepoint
CCR2 and CCR5 corresponding ligands' messenger ribonucleic acid (mRNA) gene expression were assessed in frozen adipose tissue by quantitative polymerase chain reaction (PCR). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=15 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=21 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue
CCR2, Change from Baseline to Week 24
|
2.6 copies per sample
Interval 0.5 to 4.6
|
0.8 copies per sample
Interval -2.7 to 1.8
|
|
Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue
CCR2, Baseline
|
13.0 copies per sample
Interval 6.75 to 16.5
|
13.7 copies per sample
Interval 4.37 to 16.9
|
|
Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue
CCR5, Baseline
|
12.7 copies per sample
Interval 8.19 to 17.3
|
15.2 copies per sample
Interval 4.75 to 17.8
|
|
Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue
CCR5, Change from Baseline to Week 24
|
3.6 copies per sample
Interval -0.7 to 5.2
|
0.1 copies per sample
Interval -1.6 to 1.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Peripheral monocyte subsets (cluster of differentiation 14 (CD14/cluster of differentiation 16 (CD16)\] were measured in fresh peripheral blood mononuclear cells (PBMCs) samples by flow cytometry. Monocyte results are reported for Total, Classical (CD14+CD16-), Intermediate (CD14+CD16+) and Non-classical (CD14lowCD16+). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=15 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=21 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Total Monocytes, Change from Baseline to Week 24
|
0 cells/μL
Interval -200.0 to 0.0
|
0 cells/μL
Interval -100.0 to 0.0
|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Classical Monocytes, Baseline
|
258 cells/μL
Interval 179.0 to 368.0
|
351 cells/μL
Interval 321.0 to 468.0
|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Classical Monocytes, Change from BL to Week 24
|
-43.6 cells/μL
Interval -132.0 to 14.2
|
-31 cells/μL
Interval -91.0 to 18.0
|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Intermediate Monocytes, Baseline
|
16.8 cells/μL
Interval 14.6 to 23.6
|
22.4 cells/μL
Interval 11.8 to 32.0
|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Intermediate Monocytes, Change from BL to Week 24
|
-1.4 cells/μL
Interval -10.2 to 2.5
|
3.8 cells/μL
Interval -4.7 to 25.8
|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Total Monocytes, Baseline (BL)
|
400 cells/μL
Interval 200.0 to 400.0
|
400 cells/μL
Interval 400.0 to 500.0
|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Non-Classical Monocytes, Baseline
|
24.9 cells/μL
Interval 16.8 to 42.3
|
30.9 cells/μL
Interval 18.4 to 46.1
|
|
Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)
Non-Classical Monocytes, Change from BL to Week 24
|
-7.1 cells/μL
Interval -15.4 to 0.0
|
-2.4 cells/μL
Interval -16.6 to 1.7
|
SECONDARY outcome
Timeframe: Baseline (Day1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Baseline
|
119.55 mg/dL
Standard Deviation 28.849
|
122.84 mg/dL
Standard Deviation 33.212
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from Baseline to Week 12
|
-5.56 mg/dL
Standard Deviation 24.328
|
-3.96 mg/dL
Standard Deviation 24.412
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from Baseline to Week 24
|
-3.25 mg/dL
Standard Deviation 19.206
|
-7.83 mg/dL
Standard Deviation 25.610
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A fasting blood sample was collected and was sent to a central laboratory for analysis of insulin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Insulin (FPI)
Baseline
|
33.42 μIU/mL
Standard Deviation 26.427
|
33.38 μIU/mL
Standard Deviation 24.135
|
|
Change From Baseline in Fasting Plasma Insulin (FPI)
Change from Baseline to Week 12
|
-1.56 μIU/mL
Standard Deviation 10.204
|
-5.26 μIU/mL
Standard Deviation 19.412
|
|
Change From Baseline in Fasting Plasma Insulin (FPI)
Change from Baseline to Week 24
|
-0.27 μIU/mL
Standard Deviation 8.464
|
-6.83 μIU/mL
Standard Deviation 18.312
|
SECONDARY outcome
Timeframe: Baseline (Day1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
QUICKI is used to measure insulin sensitivity. QUICKI = 1/(log FPI μIU/mL + log FPG mg/dL). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)
Baseline
|
0.29 unit on a scale
Standard Deviation 0.025
|
0.29 unit on a scale
Standard Deviation 0.023
|
|
Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)
Change from Baseline to Week 12
|
0.00 unit on a scale
Standard Deviation 0.018
|
0.00 unit on a scale
Standard Deviation 0.020
|
|
Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)
Change from Baseline to Week 24
|
0.01 unit on a scale
Standard Deviation 0.019
|
0.01 unit on a scale
Standard Deviation 0.020
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
HOMA-IR = (FPG mg/dL x FPI μIU/mL)/405. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR)
Baseline
|
10.56 unit on a scale
Standard Deviation 10.407
|
10.29 unit on a scale
Standard Deviation 8.931
|
|
Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR)
Change from Baseline to Week 12
|
-0.49 unit on a scale
Standard Deviation 3.182
|
-1.96 unit on a scale
Standard Deviation 8.513
|
|
Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR)
Change from Baseline to Week 24
|
-0.11 unit on a scale
Standard Deviation 3.170
|
-3.07 unit on a scale
Standard Deviation 7.222
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
HOMA-%B= (20 × FPI)/(FPG - 3.5). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B)
Baseline
|
5.63 unit on a scale
Standard Deviation 3.577
|
5.77 unit on a scale
Standard Deviation 4.079
|
|
Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B)
Change from Baseline to Week 12
|
-0.02 unit on a scale
Standard Deviation 1.795
|
-0.74 unit on a scale
Standard Deviation 2.649
|
|
Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B)
Change from Baseline to Week 24
|
-0.15 unit on a scale
Standard Deviation 1.304
|
-0.73 unit on a scale
Standard Deviation 3.036
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Glycosylated Hemoglobin A1c (HbA1c)
Baseline
|
6.09 percentage of HbA1c
Standard Deviation 0.735
|
6.23 percentage of HbA1c
Standard Deviation 0.778
|
|
Change From Baseline in Fasting Glycosylated Hemoglobin A1c (HbA1c)
Change from Baseline to Week 12
|
-0.12 percentage of HbA1c
Standard Deviation 0.634
|
0.09 percentage of HbA1c
Standard Deviation 0.379
|
|
Change From Baseline in Fasting Glycosylated Hemoglobin A1c (HbA1c)
Change from Baseline to Week 24
|
-0.11 percentage of HbA1c
Standard Deviation 0.567
|
0.00 percentage of HbA1c
Standard Deviation 0.503
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A fasting blood sample was collected and was sent to a central laboratory for analysis of glucagon. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Glucagon Concentration
Baseline
|
154.26 ng/mL
Standard Deviation 32.877
|
169.13 ng/mL
Standard Deviation 36.591
|
|
Change From Baseline in Plasma Glucagon Concentration
Change from Baseline to Week 12
|
20.25 ng/mL
Standard Deviation 23.251
|
4.61 ng/mL
Standard Deviation 36.505
|
|
Change From Baseline in Plasma Glucagon Concentration
Change from Baseline to Week 24
|
19.07 ng/mL
Standard Deviation 35.977
|
19.14 ng/mL
Standard Deviation 53.373
|
SECONDARY outcome
Timeframe: Prior to Glucose Load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of glucose.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: Prior to Glucose Load
|
107.88 mg/dL
Standard Deviation 12.638
|
119.39 mg/dL
Standard Deviation 28.800
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 30 minutes
|
193.93 mg/dL
Standard Deviation 32.458
|
205.90 mg/dL
Standard Deviation 50.327
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 60 minutes
|
201.44 mg/dL
Standard Deviation 49.884
|
232.74 mg/dL
Standard Deviation 62.174
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 90 minutes
|
173.56 mg/dL
Standard Deviation 56.169
|
227.00 mg/dL
Standard Deviation 76.041
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 120 minutes
|
158.38 mg/dL
Standard Deviation 46.411
|
201.04 mg/dL
Standard Deviation 82.832
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: Prior to Glucose Load
|
111.47 mg/dL
Standard Deviation 20.035
|
114.88 mg/dL
Standard Deviation 39.591
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 30 minutes
|
198.60 mg/dL
Standard Deviation 44.223
|
198.65 mg/dL
Standard Deviation 59.787
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 60 minutes
|
214.93 mg/dL
Standard Deviation 58.414
|
232.09 mg/dL
Standard Deviation 66.036
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 90 minutes
|
187.20 mg/dL
Standard Deviation 53.835
|
220.61 mg/dL
Standard Deviation 78.385
|
|
Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 120 minutes
|
165.73 mg/dL
Standard Deviation 53.378
|
191.26 mg/dL
Standard Deviation 86.539
|
SECONDARY outcome
Timeframe: Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of insulin.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 120 minutes
|
216.00 μIU/mL
Standard Deviation 119.872
|
265.00 μIU/mL
Standard Deviation 287.361
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: Prior to Glucose Load
|
25.94 μIU/mL
Standard Deviation 12.065
|
27.96 μIU/mL
Standard Deviation 14.366
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 30 minutes
|
168.71 μIU/mL
Standard Deviation 61.276
|
170.83 μIU/mL
Standard Deviation 162.459
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 60 minutes
|
211.76 μIU/mL
Standard Deviation 72.218
|
203.29 μIU/mL
Standard Deviation 168.986
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 90 minutes
|
204.47 μIU/mL
Standard Deviation 108.028
|
236.63 μIU/mL
Standard Deviation 168.861
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 120 minutes
|
218.71 μIU/mL
Standard Deviation 158.013
|
223.96 μIU/mL
Standard Deviation 172.155
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: Prior to Glucose Load
|
25.25 μIU/mL
Standard Deviation 15.571
|
26.54 μIU/mL
Standard Deviation 12.608
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 30 minutes
|
172.31 μIU/mL
Standard Deviation 78.152
|
145.26 μIU/mL
Standard Deviation 106.082
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 60 minutes
|
219.63 μIU/mL
Standard Deviation 134.629
|
217.57 μIU/mL
Standard Deviation 181.115
|
|
Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 90 minutes
|
218.06 μIU/mL
Standard Deviation 105.188
|
233.22 μIU/mL
Standard Deviation 175.669
|
SECONDARY outcome
Timeframe: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
AUC(0-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Area Under the Concentration-time Curve From Time 0 to 120 Minutes [AUC (0-120 Min)] for Serum Glucose
Baseline
|
22601 minutes (min)*mg/dL
Standard Deviation 6423
|
24977 minutes (min)*mg/dL
Standard Deviation 5543
|
|
Change From Baseline in Area Under the Concentration-time Curve From Time 0 to 120 Minutes [AUC (0-120 Min)] for Serum Glucose
Change from Baseline to Week 12
|
-1071 minutes (min)*mg/dL
Standard Deviation 4098
|
-1031 minutes (min)*mg/dL
Standard Deviation 3322
|
|
Change From Baseline in Area Under the Concentration-time Curve From Time 0 to 120 Minutes [AUC (0-120 Min)] for Serum Glucose
Change from Baseline to Week 24
|
329 minutes (min)*mg/dL
Standard Deviation 4883
|
-1085 minutes (min)*mg/dL
Standard Deviation 4178
|
SECONDARY outcome
Timeframe: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
AUC(30-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Area Under the Concentration-time Curve From Time 30 to 120 Minutes [AUC (30-120 Min)] for Serum Glucose
Baseline
|
17816 minutes (min)*mg/dL
Standard Deviation 5488
|
20097 minutes (min)*mg/dL
Standard Deviation 4620
|
|
Change From Baseline in Area Under the Concentration-time Curve From Time 30 to 120 Minutes [AUC (30-120 Min)] for Serum Glucose
Change from Baseline to Week 12
|
-941 minutes (min)*mg/dL
Standard Deviation 3490
|
-923 minutes (min)*mg/dL
Standard Deviation 3092
|
|
Change From Baseline in Area Under the Concentration-time Curve From Time 30 to 120 Minutes [AUC (30-120 Min)] for Serum Glucose
Change from Baseline to Week 24
|
383 minutes (min)*mg/dL
Standard Deviation 4380
|
-889 minutes (min)*mg/dL
Standard Deviation 3497
|
SECONDARY outcome
Timeframe: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
AUC(0-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in AUC (0-120 Min) for Plasma Insulin
Baseline
|
21261 min*μIU/mL
Standard Deviation 10716
|
24411 min*μIU/mL
Standard Deviation 13942
|
|
Change From Baseline in AUC (0-120 Min) for Plasma Insulin
Change from Baseline to Week 12
|
640 min*μIU/mL
Standard Deviation 6340
|
-1850 min*μIU/mL
Standard Deviation 6916
|
|
Change From Baseline in AUC (0-120 Min) for Plasma Insulin
Change from Baseline to Week 24
|
2101 min*μIU/mL
Standard Deviation 8088
|
-1703 min*μIU/mL
Standard Deviation 9109
|
SECONDARY outcome
Timeframe: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
AUC(30-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in AUC (30-120 Min) for Plasma Insulin
Baseline
|
18178 min*μIU/mL
Standard Deviation 9082
|
21583 min*μIU/mL
Standard Deviation 12626
|
|
Change From Baseline in AUC (30-120 Min) for Plasma Insulin
Change from Baseline to Week 12
|
472 min*μIU/mL
Standard Deviation 5730
|
-1830 min*μIU/mL
Standard Deviation 6532
|
|
Change From Baseline in AUC (30-120 Min) for Plasma Insulin
Change from Baseline to Week 24
|
1818 min*μIU/mL
Standard Deviation 7506
|
-1467 min*μIU/mL
Standard Deviation 8523
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A fasting blood sample was collected and was sent to a central laboratory for analysis of free fatty acids. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Free Fatty Acids
Baseline
|
15.36 mg/dL
Standard Deviation 5.708
|
17.41 mg/dL
Standard Deviation 6.913
|
|
Change From Baseline in Fasting Free Fatty Acids
Change from Baseline to Week 12
|
-0.74 mg/dL
Standard Deviation 5.214
|
0.31 mg/dL
Standard Deviation 7.489
|
|
Change From Baseline in Fasting Free Fatty Acids
Change from Baseline to Week 24
|
-0.09 mg/dL
Standard Deviation 6.466
|
-2.65 mg/dL
Standard Deviation 8.856
|
SECONDARY outcome
Timeframe: Baseline (Day1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A fasting blood sample was collected and was sent to a central laboratory for analysis of adiponectin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Adiponectin Concentration
Baseline
|
3.99 μg/mL
Standard Deviation 2.162
|
4.50 μg/mL
Standard Deviation 2.253
|
|
Change From Baseline in Serum Adiponectin Concentration
Change from Baseline to Week 12
|
-0.01 μg/mL
Standard Deviation 0.465
|
0.01 μg/mL
Standard Deviation 0.937
|
|
Change From Baseline in Serum Adiponectin Concentration
Change from Baseline to Week 24
|
0.64 μg/mL
Standard Deviation 2.693
|
-0.82 μg/mL
Standard Deviation 2.222
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A fasting blood sample was collected and was sent to a central laboratory for analysis of resistin. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Resistin Concentration
Baseline
|
10.46 ng/mL
Standard Deviation 3.724
|
10.44 ng/mL
Standard Deviation 4.422
|
|
Change From Baseline in Serum Resistin Concentration
Change from Baseline to Week 12
|
-0.49 ng/mL
Standard Deviation 3.019
|
0.10 ng/mL
Standard Deviation 3.316
|
|
Change From Baseline in Serum Resistin Concentration
Change from Baseline to Week 24
|
-0.01 ng/mL
Standard Deviation 4.168
|
-1.19 ng/mL
Standard Deviation 2.957
|
SECONDARY outcome
Timeframe: Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of FFA.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 90 minutes
|
4.17 mg/dL
Standard Deviation 2.238
|
5.66 mg/dL
Standard Deviation 2.545
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 120 minutes
|
2.73 mg/dL
Standard Deviation 1.092
|
4.05 mg/dL
Standard Deviation 2.749
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: Prior to Glucose Load
|
15.60 mg/dL
Standard Deviation 5.578
|
17.44 mg/dL
Standard Deviation 5.620
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 30 minutes
|
12.01 mg/dL
Standard Deviation 5.464
|
14.24 mg/dL
Standard Deviation 3.783
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 60 minutes
|
6.63 mg/dL
Standard Deviation 3.925
|
8.85 mg/dL
Standard Deviation 2.702
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 90 minutes
|
4.16 mg/dL
Standard Deviation 3.104
|
5.43 mg/dL
Standard Deviation 2.424
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 12: 120 minutes
|
2.52 mg/dL
Standard Deviation 1.378
|
4.08 mg/dL
Standard Deviation 2.057
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: Prior to Glucose Load
|
16.62 mg/dL
Standard Deviation 4.162
|
14.60 mg/dL
Standard Deviation 5.089
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 30 minutes
|
13.05 mg/dL
Standard Deviation 5.059
|
12.84 mg/dL
Standard Deviation 3.590
|
|
Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load
Week 24: 60 minutes
|
7.41 mg/dL
Standard Deviation 3.462
|
8.23 mg/dL
Standard Deviation 3.376
|
SECONDARY outcome
Timeframe: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
AUC(0-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in AUC (0-120 Min) for Serum FFA
Baseline
|
37.2 min*mmol/L
Standard Deviation 14.27
|
42.9 min*mmol/L
Standard Deviation 14.57
|
|
Change From Baseline in AUC (0-120 Min) for Serum FFA
Change from Baseline to Week 12
|
-5.4 min*mmol/L
Standard Deviation 10.16
|
-1.3 min*mmol/L
Standard Deviation 14.46
|
|
Change From Baseline in AUC (0-120 Min) for Serum FFA
Change from Baseline to Week 24
|
-3.4 min*mmol/L
Standard Deviation 11.74
|
-4.2 min*mmol/L
Standard Deviation 18.98
|
SECONDARY outcome
Timeframe: Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
AUC(30-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in AUC (30-120 Min) for Serum FFA
Baseline
|
23.3 min*mmol/L
Standard Deviation 11.55
|
25.6 min*mmol/L
Standard Deviation 8.59
|
|
Change From Baseline in AUC (30-120 Min) for Serum FFA
Change from Baseline to Week 12
|
-5.0 min*mmol/L
Standard Deviation 7.49
|
-0.9 min*mmol/L
Standard Deviation 8.65
|
|
Change From Baseline in AUC (30-120 Min) for Serum FFA
Change from Baseline to Week 24
|
-4.2 min*mmol/L
Standard Deviation 8.61
|
-1.5 min*mmol/L
Standard Deviation 11.08
|
SECONDARY outcome
Timeframe: Baseline (Screening) to Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Only participants confirmed at Screening with NASH by biopsy and had a biopsy conducted at Week 24 were included in the analysis.
Liver biopsy were performed during Screening and at Week 24 only for participants diagnosed with NASH. NAFLD activity score was determined based on 3 components: steatosis (0=\<5% to 3=\>66%), lobular inflammation (0=no foci to 3=\>4 foci/200x) and hepatocellular ballooning (0=none to 2= many cells/prominent ballooning) for a total possible score of 0 to 8. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=6 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=12 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in the Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
Baseline
|
4.33 score on a scale
Standard Deviation 0.816
|
4.00 score on a scale
Standard Deviation 1.279
|
|
Change From Baseline in the Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
Change from Baseline to Week 24
|
-1.00 score on a scale
Standard Deviation 1.265
|
-0.33 score on a scale
Standard Deviation 1.670
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Only participants confirmed at Screening with NASH by biopsy and had a biopsy conducted at Week 24 were included.
Liver biopsy were performed during Screening and at Week 24 for participants diagnosed with NASH. The NASH CRN Brunt/Kleiner Fibrosis Staging System Fibrosis Stages are: 0 (None), 1 (Perisinusoidal or periportal), 1A (Mild, zone 3, perisinusoidal), 1B (Moderate, zone 3, perisinusoidal), 1C (Portal/periportal), 2 (Perisinusoidal and portal/periportal), 3 (Bridging fibrosis) and 4 (Cirrhosis).
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=6 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=12 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 0
|
2 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 1
|
2 Participants
|
7 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 1A
|
1 Participants
|
3 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 1B
|
0 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 1C
|
0 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 2
|
0 Participants
|
2 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 3
|
1 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Baseline: Stage 4
|
0 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24: Stage 0
|
2 Participants
|
4 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24: Stage 1
|
3 Participants
|
6 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24: Stage 1A
|
0 Participants
|
2 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24: Stage 1B
|
0 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24: Stage 1C
|
0 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24: Stage 2
|
0 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24: Stage 3
|
1 Participants
|
0 Participants
|
|
Number of Participants by NASH Clinical Research Network (CRN) Staging Categories
Week 24 : Stage 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of MCP-1. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 2 (CCR2) Ligand: Monocyte Chemotactic Protein 1 (MCP-1)
Baseline
|
445.86 pg/mL
Standard Deviation 140.656
|
408.19 pg/mL
Standard Deviation 117.099
|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 2 (CCR2) Ligand: Monocyte Chemotactic Protein 1 (MCP-1)
Change from Baseline to Week 2
|
1333.68 pg/mL
Standard Deviation 497.505
|
37.58 pg/mL
Standard Deviation 71.741
|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 2 (CCR2) Ligand: Monocyte Chemotactic Protein 1 (MCP-1)
Change from Baseline to Week 12
|
1461.98 pg/mL
Standard Deviation 663.465
|
31.98 pg/mL
Standard Deviation 80.034
|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 2 (CCR2) Ligand: Monocyte Chemotactic Protein 1 (MCP-1)
Change from Baseline to Week 24
|
1248.86 pg/mL
Standard Deviation 661.883
|
13.87 pg/mL
Standard Deviation 79.726
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of RANTES (regulated on activation normal T-cell expressed and secreted). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 5 (CCR5) Ligand: RANTES
Baseline
|
36.95 ng/mL
Standard Deviation 19.267
|
46.33 ng/mL
Standard Deviation 28.419
|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 5 (CCR5) Ligand: RANTES
Change from Baseline to Week 2
|
-1.53 ng/mL
Standard Deviation 20.643
|
-1.13 ng/mL
Standard Deviation 20.726
|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 5 (CCR5) Ligand: RANTES
Change from Baseline to Week 12
|
-2.53 ng/mL
Standard Deviation 18.729
|
0.65 ng/mL
Standard Deviation 19.310
|
|
Change From Baseline in Serum C-C Chemokine Receptor Type 5 (CCR5) Ligand: RANTES
Change from Baseline to Week 24
|
-2.13 ng/mL
Standard Deviation 29.003
|
-5.35 ng/mL
Standard Deviation 28.724
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of MIP-1α. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Alpha (MIP-1α)
Baseline
|
69.66 pg/mL
Standard Deviation 20.275
|
62.85 pg/mL
Standard Deviation 15.737
|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Alpha (MIP-1α)
Change from Baseline to Week 2
|
64.11 pg/mL
Standard Deviation 21.811
|
-0.11 pg/mL
Standard Deviation 8.583
|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Alpha (MIP-1α)
Change from Baseline to Week 12
|
63.75 pg/mL
Standard Deviation 21.811
|
-6.28 pg/mL
Standard Deviation 10.135
|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Alpha (MIP-1α)
Change from Baseline to Week 24
|
61.08 pg/mL
Standard Deviation 18.224
|
-2.79 pg/mL
Standard Deviation 9.445
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of MIP-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Beta (MIP-1β)
Baseline
|
120.59 pg/mL
Standard Deviation 40.483
|
102.85 pg/mL
Standard Deviation 41.424
|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Beta (MIP-1β)
Change from Baseline to Week 2
|
163.26 pg/mL
Standard Deviation 77.537
|
1.06 pg/mL
Standard Deviation 15.232
|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Beta (MIP-1β)
Change from Baseline to Week 12
|
152.21 pg/mL
Standard Deviation 67.341
|
-3.04 pg/mL
Standard Deviation 20.482
|
|
Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Beta (MIP-1β)
Change from Baseline to Week 24
|
147.83 pg/mL
Standard Deviation 58.465
|
-7.42 pg/mL
Standard Deviation 15.499
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of IL-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 1 Beta (IL-1β)
Change from Baseline to Week 24
|
-0.03 pg/mL
Standard Deviation 0.071
|
-0.14 pg/mL
Standard Deviation 0.420
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 1 Beta (IL-1β)
Baseline
|
0.08 pg/mL
Standard Deviation 0.058
|
0.20 pg/mL
Standard Deviation 0.413
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 1 Beta (IL-1β)
Change from Baseline to Week 2
|
-0.03 pg/mL
Standard Deviation 0.082
|
-0.16 pg/mL
Standard Deviation 0.413
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 1 Beta (IL-1β)
Change from Baseline to Week 12
|
-0.01 pg/mL
Standard Deviation 0.100
|
-0.17 pg/mL
Standard Deviation 0.418
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of IL-6. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 6 (IL-6)
Baseline
|
3.54 pg/mL
Standard Deviation 3.208
|
3.68 pg/mL
Standard Deviation 2.274
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 6 (IL-6)
Change from Baseline to Week 2
|
-0.67 pg/mL
Standard Deviation 2.885
|
-0.11 pg/mL
Standard Deviation 2.091
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 6 (IL-6)
Change from Baseline to Week 12
|
-0.88 pg/mL
Standard Deviation 3.299
|
0.20 pg/mL
Standard Deviation 3.018
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 6 (IL-6)
Change from Baseline to Week 24
|
-1.18 pg/mL
Standard Deviation 2.958
|
1.08 pg/mL
Standard Deviation 6.017
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of IL-8. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 8 (IL-8)
Baseline
|
21.99 pg/mL
Standard Deviation 8.454
|
18.42 pg/mL
Standard Deviation 5.669
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 8 (IL-8)
Change from Baseline to Week 2
|
0.55 pg/mL
Standard Deviation 7.982
|
3.29 pg/mL
Standard Deviation 7.846
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 8 (IL-8)
Change from Baseline to Week 12
|
4.16 pg/mL
Standard Deviation 9.739
|
0.44 pg/mL
Standard Deviation 7.475
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 8 (IL-8)
Change from Baseline to Week 24
|
1.31 pg/mL
Standard Deviation 6.228
|
-0.45 pg/mL
Standard Deviation 6.452
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of IL-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 10 (IL-10)
Baseline
|
3.05 pg/mL
Standard Deviation 0.908
|
3.06 pg/mL
Standard Deviation 0.694
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 10 (IL-10)
Change from Baseline to Week 2
|
0.20 pg/mL
Standard Deviation 0.772
|
0.10 pg/mL
Standard Deviation 0.861
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 10 (IL-10)
Change from Baseline to Week 12
|
0.07 pg/mL
Standard Deviation 0.896
|
-0.17 pg/mL
Standard Deviation 0.979
|
|
Change From Baseline in Biomarker of Inflammation: Interleukin 10 (IL-10)
Change from Baseline to Week 24
|
-0.61 pg/mL
Standard Deviation 0.406
|
-0.37 pg/mL
Standard Deviation 0.897
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12, 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of hs-CRP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Biomarker of Inflammation: High Sensitivity C Reactive Protein (Hs-CRP)
Baseline
|
6.39 mg/L
Standard Deviation 9.232
|
5.39 mg/L
Standard Deviation 7.421
|
|
Change From Baseline in Biomarker of Inflammation: High Sensitivity C Reactive Protein (Hs-CRP)
Change from Baseline to Week 2
|
-1.58 mg/L
Standard Deviation 4.642
|
0.12 mg/L
Standard Deviation 2.934
|
|
Change From Baseline in Biomarker of Inflammation: High Sensitivity C Reactive Protein (Hs-CRP)
Change from Baseline to Week 12
|
-0.50 mg/L
Standard Deviation 8.402
|
2.33 mg/L
Standard Deviation 6.813
|
|
Change From Baseline in Biomarker of Inflammation: High Sensitivity C Reactive Protein (Hs-CRP)
Change from Baseline to Week 24
|
-1.35 mg/L
Standard Deviation 2.843
|
0.14 mg/L
Standard Deviation 5.615
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 2, 12, 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of TNF-α. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Biomarker of Inflammation: Tumor Necrosis Factor Alpha (TNF-α)
Baseline
|
12.78 pg/mL
Standard Deviation 3.208
|
12.35 pg/mL
Standard Deviation 2.526
|
|
Change From Baseline in Biomarker of Inflammation: Tumor Necrosis Factor Alpha (TNF-α)
Change from Baseline to Week 2
|
0.68 pg/mL
Standard Deviation 2.577
|
-0.43 pg/mL
Standard Deviation 2.592
|
|
Change From Baseline in Biomarker of Inflammation: Tumor Necrosis Factor Alpha (TNF-α)
Change from Baseline to Week 12
|
0.58 pg/mL
Standard Deviation 2.894
|
-0.69 pg/mL
Standard Deviation 2.484
|
|
Change From Baseline in Biomarker of Inflammation: Tumor Necrosis Factor Alpha (TNF-α)
Change from Baseline to Week 24
|
-0.06 pg/mL
Standard Deviation 2.320
|
-0.97 pg/mL
Standard Deviation 2.361
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of Hyaluronic Acid. A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Hyaluronic Acid
Baseline
|
24.65 ng/mL
Standard Deviation 18.511
|
19.78 ng/mL
Standard Deviation 7.740
|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Hyaluronic Acid
Change from Baseline to Week 24
|
12.69 ng/mL
Standard Deviation 19.622
|
4.86 ng/mL
Standard Deviation 15.743
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of CK-18. A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Cytokeratin-18 (CK-18) [M30 and M65]
Baseline
|
399.35 U/L
Standard Deviation 352.261
|
485.72 U/L
Standard Deviation 547.707
|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Cytokeratin-18 (CK-18) [M30 and M65]
Change from Baseline to Week 24
|
1.88 U/L
Standard Deviation 235.362
|
-88.00 U/L
Standard Deviation 338.731
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of FGF-21. A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Fibroblast Growth Factor-21 (FGF-21)
Baseline
|
266.75 pg/mL
Standard Deviation 119.590
|
406.91 pg/mL
Standard Deviation 260.751
|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Fibroblast Growth Factor-21 (FGF-21)
Change from Baseline to Week 24
|
-3.53 pg/mL
Standard Deviation 156.894
|
427.38 pg/mL
Standard Deviation 1925.089
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of Mac-2BP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Mac-2 Binding Protein (Mac-2BP)
Baseline
|
5440.50 ng/mL
Standard Deviation 1829.772
|
7156.96 ng/mL
Standard Deviation 5336.192
|
|
Change From Baseline in Noninvasive Metabolic Biomarker: Mac-2 Binding Protein (Mac-2BP)
Change from Baseline to Week 24
|
20.94 ng/mL
Standard Deviation 967.192
|
-844.77 ng/mL
Standard Deviation 2231.155
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of CD95. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Noninvasive Metabolic Serum Biomarker: Cluster of Differentiation (CD95)
Baseline
|
10.99 ng/mL
Standard Deviation 2.478
|
11.11 ng/mL
Standard Deviation 1.737
|
|
Change From Baseline in Noninvasive Metabolic Serum Biomarker: Cluster of Differentiation (CD95)
Change from Baseline to Week 24
|
-0.34 ng/mL
Standard Deviation 2.259
|
-1.00 ng/mL
Standard Deviation 2.085
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Blood was collected and was sent to a central laboratory for analysis of AFP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Noninvasive Metabolic Marker: Alpha-fetoprotein (AFP)
Baseline
|
3.10 ng/mL
Standard Deviation 1.483
|
2.91 ng/mL
Standard Deviation 1.925
|
|
Change From Baseline in Noninvasive Metabolic Marker: Alpha-fetoprotein (AFP)
Change from Baseline to Week 24
|
0.00 ng/mL
Standard Deviation 0.730
|
-0.14 ng/mL
Standard Deviation 0.727
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.
LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=7 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=10 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Fat Fraction
Baseline
|
15.21 percentage of fat
Standard Deviation 9.112
|
13.56 percentage of fat
Standard Deviation 7.987
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Fat Fraction
Change from Baseline to Week 12
|
-0.05 percentage of fat
Standard Deviation 1.822
|
-2.75 percentage of fat
Standard Deviation 7.121
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Fat Fraction
Change from Baseline to Week 24
|
1.08 percentage of fat
Standard Deviation 3.238
|
-5.37 percentage of fat
Standard Deviation 7.486
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.
LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24. The mean of 4 regions of interest as selected by the technician is reported. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=7 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=10 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Corrected T1 (cT1)
Baseline
|
923.72 milliseconds (ms)
Standard Deviation 76.249
|
911.97 milliseconds (ms)
Standard Deviation 88.007
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Corrected T1 (cT1)
Change from Baseline to Week 12
|
-10.62 milliseconds (ms)
Standard Deviation 22.211
|
-5.60 milliseconds (ms)
Standard Deviation 52.203
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Corrected T1 (cT1)
Change from Baseline to Week 24
|
0.03 milliseconds (ms)
Standard Deviation 28.771
|
-3.95 milliseconds (ms)
Standard Deviation 55.402
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.
LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=7 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=10 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: cT1 Mode Values Within the Liver
Baseline
|
917.95 ms
Standard Deviation 68.147
|
901.67 ms
Standard Deviation 77.461
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: cT1 Mode Values Within the Liver
Change from Baseline to Week 12
|
-15.37 ms
Standard Deviation 18.348
|
-4.00 ms
Standard Deviation 42.298
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: cT1 Mode Values Within the Liver
Change from Baseline to Week 24
|
-2.83 ms
Standard Deviation 18.707
|
0.89 ms
Standard Deviation 42.722
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.
LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. The mean of 4 regions of interest as selected by the technician is reported. The LIF Score ranges from 0=no liver disease to 4=severe liver disease. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=7 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=10 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Liver Inflammation and Fibrosis (LIF) Score
Baseline
|
2.50 unit on a scale
Standard Deviation 0.853
|
2.34 unit on a scale
Standard Deviation 0.868
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Liver Inflammation and Fibrosis (LIF) Score
Change from Baseline to Week 12
|
-0.11 unit on a scale
Standard Deviation 0.259
|
-0.01 unit on a scale
Standard Deviation 0.450
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Liver Inflammation and Fibrosis (LIF) Score
Change from Baseline to Week 24
|
0.01 unit on a scale
Standard Deviation 0.345
|
-0.00 unit on a scale
Standard Deviation 0.505
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.
LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=7 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=10 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Iron Content
Baseline
|
1.24 mg/g of liver
Standard Deviation 0.151
|
1.29 mg/g of liver
Standard Deviation 0.152
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Iron Content
Change from Baseline to Week 12
|
0.03 mg/g of liver
Standard Deviation 0.121
|
-0.06 mg/g of liver
Standard Deviation 0.117
|
|
Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Iron Content
Change from Baseline to Week 24
|
0.00 mg/g of liver
Standard Deviation 0.122
|
-0.14 mg/g of liver
Standard Deviation 0.151
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.
A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Body Weight
Change from Baseline to Week 24
|
0.03 kg
Standard Deviation 3.656
|
-2.44 kg
Standard Deviation 4.417
|
|
Change From Baseline in Body Weight
Baseline
|
94.92 kg
Standard Deviation 14.282
|
100.92 kg
Standard Deviation 15.359
|
|
Change From Baseline in Body Weight
Change from Baseline to Week 2
|
-0.22 kg
Standard Deviation 1.760
|
-1.10 kg
Standard Deviation 2.008
|
|
Change From Baseline in Body Weight
Change from Baseline to Week 4
|
-0.52 kg
Standard Deviation 2.417
|
-1.43 kg
Standard Deviation 2.453
|
|
Change From Baseline in Body Weight
Change from Baseline to Week 8
|
0.21 kg
Standard Deviation 2.029
|
-1.56 kg
Standard Deviation 3.162
|
|
Change From Baseline in Body Weight
Change from Baseline to Week 12
|
0.53 kg
Standard Deviation 2.967
|
-1.50 kg
Standard Deviation 3.879
|
|
Change From Baseline in Body Weight
Change from Baseline to Week 16
|
0.87 kg
Standard Deviation 3.160
|
-1.73 kg
Standard Deviation 4.018
|
|
Change From Baseline in Body Weight
Change from Baseline to Week 20
|
0.17 kg
Standard Deviation 3.555
|
-2.15 kg
Standard Deviation 4.152
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.
Blood was collected and was sent to a central laboratory for analysis of ALT. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Liver Transaminase: Alanine Aminotransferase (ALT)
Baseline
|
55.76 U/L
Standard Deviation 42.044
|
51.28 U/L
Standard Deviation 39.066
|
|
Change From Baseline in Liver Transaminase: Alanine Aminotransferase (ALT)
Change from Baseline to Week 12
|
-0.22 U/L
Standard Deviation 14.621
|
-6.88 U/L
Standard Deviation 19.856
|
|
Change From Baseline in Liver Transaminase: Alanine Aminotransferase (ALT)
Change from Baseline to Week 24
|
0.40 U/L
Standard Deviation 21.223
|
-8.95 U/L
Standard Deviation 24.300
|
SECONDARY outcome
Timeframe: Baseline to Weeks 12 and 24Population: Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.
Blood was collected and was sent to a central laboratory for analysis of AST. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Liver Transaminase: Aspartate Aminotransferase (AST)
Baseline
|
33.88 U/L
Standard Deviation 17.885
|
36.10 U/L
Standard Deviation 26.712
|
|
Change From Baseline in Liver Transaminase: Aspartate Aminotransferase (AST)
Change from Baseline to Week 12
|
0.46 U/L
Standard Deviation 9.447
|
-3.31 U/L
Standard Deviation 16.374
|
|
Change From Baseline in Liver Transaminase: Aspartate Aminotransferase (AST)
Change from Baseline to Week 24
|
1.57 U/L
Standard Deviation 13.022
|
-3.75 U/L
Standard Deviation 15.966
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety Population included all participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving study drug.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
|
10 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety Population included all participants who received at least one dose of study drug.
Vital signs included Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Respiratory Rate and Temperature. The investigator determined if the vital sign measurements were clinically relevant.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline 24 weeksPopulation: Safety Population included all participants who received at least one dose of study drug.
A standard 12 lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) one sample predose; Weeks 2, 12 and 24 one sample predose and one sample postdosePopulation: Pharmacokinetic (PK) Population included all participants in the safety population who received at least 1 dose of study drug and had at least 1 PK assessment.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Plasma Cenicriviroc Concentrations
Baseline: Pre-Dose
|
0.0 ng/mL
Standard Deviation 0.00
|
—
|
|
Plasma Cenicriviroc Concentrations
Week 2: Pre-Dose
|
168.7 ng/mL
Standard Deviation 165.53
|
—
|
|
Plasma Cenicriviroc Concentrations
Week 2: Post-Dose
|
170.7 ng/mL
Standard Deviation 182.87
|
—
|
|
Plasma Cenicriviroc Concentrations
Week 12: Pre-Dose
|
383.3 ng/mL
Standard Deviation 755.28
|
—
|
|
Plasma Cenicriviroc Concentrations
Week 12: Post-Dose
|
320.4 ng/mL
Standard Deviation 623.34
|
—
|
|
Plasma Cenicriviroc Concentrations
Week 24: Pre-Dose
|
230.7 ng/mL
Standard Deviation 382.75
|
—
|
|
Plasma Cenicriviroc Concentrations
Week 24: Post-Dose
|
127.4 ng/mL
Standard Deviation 92.26
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety Population included all participants who received at least one dose of study drug.
Physical examination included assessment of the following body systems: Abdomen, Cardiovascular, Extremities, Head, Eyes, Ears, Nose, Throat, Lungs, Lymph Nodes, Neurological, Skin and Thyroid. The number of participants with any abnormal findings at Baseline and participants with any abnormal findings Post-Baseline are reported.
Outcome measures
| Measure |
Cenicriviroc 150 mg
n=20 Participants
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 Participants
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Physical Examination Findings
Baseline
|
3 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Post-Baseline
|
3 Participants
|
13 Participants
|
Adverse Events
Cenicriviroc 150 mg
Placebo
Serious adverse events
| Measure |
Cenicriviroc 150 mg
n=20 participants at risk
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 participants at risk
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
4.0%
1/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Cenicriviroc 150 mg
n=20 participants at risk
Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food for up to 24 weeks.
|
Placebo
n=25 participants at risk
Placebo-matching CVC, administered orally once daily and taken every morning with food for up to 24 weeks.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
8.0%
2/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
8.0%
2/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
4.0%
1/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
8.0%
2/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
4.0%
1/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Epididymitis
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
8.0%
2/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
4.0%
1/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
4.0%
1/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
2/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascial fibromatosis
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
12.0%
3/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.0%
1/20 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/25 • First dose of study drug to within 28 days post last dose of study drug (Up to approximately 29 weeks)
Safety Population included all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER