Trial Outcomes & Findings for Phase 2b Study in NASH to Assess IVA337 (NCT NCT03008070)
NCT ID: NCT03008070
Last Updated: 2023-07-19
Results Overview
SAF-A is the activity part of the Steatosis Activity Fibrosis \[SAF\] histological score, calculated as the sum of lobular inflamation score and balloning score. No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
247 participants
Primary outcome timeframe
24 weeks
Results posted on
2023-07-19
Participant Flow
Recruitment of patients started in February 2017, and last patient was recruited on March 2019. A total of 868 patients were screened for the study.
Patients were invited to participate into the study by their referent doctor according to the patient's medical records. Patients had to fulfil all the inclusion and none of the exclusion criteria to be eligible. A total of 247 patients were randomised, and 621 were not randomised.Main reason for non randomization was inclusion/exclusion criteria not met (470 - 76%).
Participant milestones
| Measure |
Lanifibranor 1200mg
Lanifibranor 400mg, once a day (Quaque Die, QD) with food
Lanifibranor: 1200mg
|
Lanifibranor 800mg
Lanifibranor 400mg, once a day (Quaque Die, QD) with food
Lanifibranor: 800mg
|
Placebo
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Overall Study
STARTED
|
83
|
83
|
81
|
|
Overall Study
COMPLETED
|
77
|
77
|
74
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
7
|
Reasons for withdrawal
| Measure |
Lanifibranor 1200mg
Lanifibranor 400mg, once a day (Quaque Die, QD) with food
Lanifibranor: 1200mg
|
Lanifibranor 800mg
Lanifibranor 400mg, once a day (Quaque Die, QD) with food
Lanifibranor: 800mg
|
Placebo
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Non compliance
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by patient and adverse event non fatal
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
|
Overall Study
Use of prohibited drug
|
0
|
0
|
2
|
Baseline Characteristics
Phase 2b Study in NASH to Assess IVA337
Baseline characteristics by cohort
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
199 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 13.8 • n=99 Participants
|
55 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
53.4 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
53.6 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
144 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
232 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
11 participants
n=107 Participants
|
12 participants
n=206 Participants
|
36 participants
n=7 Participants
|
|
Region of Enrollment
Czechia
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Region of Enrollment
Mauritius
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
32 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Region of Enrollment
Slovenia
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
3 participants
n=206 Participants
|
13 participants
n=7 Participants
|
|
Region of Enrollment
Bulgaria
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
22 participants
n=206 Participants
|
55 participants
n=7 Participants
|
|
Region of Enrollment
France
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
9 participants
n=206 Participants
|
39 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
13 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 weeksSAF-A is the activity part of the Steatosis Activity Fibrosis \[SAF\] histological score, calculated as the sum of lobular inflamation score and balloning score. No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)
Yes
|
41 Participants
|
34 Participants
|
22 Participants
|
|
SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)
No
|
42 Participants
|
49 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 24 weeksNASH improvement is defined as a decrease of at least 2 points in NAS score (sum of CRN Steatosis, Inflammation and Ballooning scores) without worsening of CRN Fibrosis score.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
NASH Improvement
No
|
30 Participants
|
40 Participants
|
55 Participants
|
|
NASH Improvement
Yes
|
53 Participants
|
43 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 24 weeksResolution of NASH is defined as a CRN Inflammation score equal to 0 or 1, and a CRN Ballooning score equal to 0. No worsening of fibrosis means that the CRN fibrosis score remains stable or decreases.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
NASH Resolution and no Worsening of Fibrosis
No
|
46 Participants
|
56 Participants
|
66 Participants
|
|
NASH Resolution and no Worsening of Fibrosis
Yes
|
37 Participants
|
27 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 24 weeksImprovement of fibrosis is defined as a decrease of at least one stage in CRN Fibrosis score. No worsening of NASH is defined as no increase of CRN Steatosis score, no increase of CRN Inflammation score ans no increase of CRN Ballooning score.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH
No
|
48 Participants
|
60 Participants
|
62 Participants
|
|
Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH
Yes
|
35 Participants
|
23 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 24 weeksSAF-A is the activity part of the Steatosis Activity Fibrosis \[SAF\] histological score, calculated as the sum of lobular inflamation score and balloning score. Improvement of SAF-A is defined as a decrease of at least 1 point.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Activity (SAF-A) Improvement
Yes
|
62 Participants
|
54 Participants
|
40 Participants
|
|
Activity (SAF-A) Improvement
No
|
21 Participants
|
29 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 24 weeksImprovement of CRN Steatosis score (CRN-S) is defined as a decrease of at least 1 point.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Steatosis (CRN-S) Improvement
Yes
|
54 Participants
|
46 Participants
|
21 Participants
|
|
Steatosis (CRN-S) Improvement
No
|
29 Participants
|
37 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: 24 weeksImprovement of CRN Lobular inflammation score (CRN-I) is defined as a decrease of at least 1 point.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Lobular Inflammation (CRN-I) Improvement
Yes
|
43 Participants
|
34 Participants
|
30 Participants
|
|
Lobular Inflammation (CRN-I) Improvement
No
|
40 Participants
|
49 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 24 weeksImprovement of CRN Ballooning (CRN-B) is defined as a decrease of at least 1 point.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Hepatocyte Balooning (CRN-B) Improvement
Yes
|
60 Participants
|
54 Participants
|
37 Participants
|
|
Hepatocyte Balooning (CRN-B) Improvement
No
|
23 Participants
|
29 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 24 weeksImprovement of CRN Fibrosis score (CRN-F) is defined as a decrease of at least 1 point.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Fibrosis (CRN-F) Improvement
Yes
|
36 Participants
|
28 Participants
|
22 Participants
|
|
Fibrosis (CRN-F) Improvement
No
|
47 Participants
|
55 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 24 weeksImprovement of Modified ISHAK Fibrosis (ISHAK-F) is defined as a decrease of at least 1 point.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Modified ISHAK Fibrosis (ISHAK-F) Improvement
No
|
42 Participants
|
51 Participants
|
56 Participants
|
|
Modified ISHAK Fibrosis (ISHAK-F) Improvement
Yes
|
41 Participants
|
32 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in ALT
|
-24.54 U/L
Standard Error 3.82
|
-26.08 U/L
Standard Error 3.85
|
-1.4 U/L
Standard Error 3.88
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in AST
|
-12.04 U/L
Standard Error 3.17
|
-15.11 U/L
Standard Error 3.2
|
-0.08 U/L
Standard Error 3.22
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=73 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in GGT
|
-27.87 U/L
Standard Error 5.57
|
-43.38 U/L
Standard Error 5.61
|
4.41 U/L
Standard Error 5.65
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
Outcome measures
| Measure |
IVA337 1200mg
n=73 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=69 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=73 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Fibrinogen
|
-0.14 g/L
Standard Error 0.81
|
-0.10 g/L
Standard Error 0.61
|
0.02 g/L
Standard Error 0.67
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Hs-CRP
|
-1.37 mg/L
Standard Error 0.46
|
-2.05 mg/L
Standard Error 0.47
|
0.11 mg/L
Standard Error 0.47
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
Outcome measures
| Measure |
IVA337 1200mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=68 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=71 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Alpha2 Macroglobulin
|
0.13 g/L
Standard Error 0.38
|
0.15 g/L
Standard Error 0.40
|
0.05 g/L
Standard Error 0.35
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Haptoglobulin
|
-0.099 g/L
Standard Error 0.378
|
-0.053 g/L
Standard Error 0.256
|
0.074 g/L
Standard Error 0.291
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=73 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=71 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change of Fasting Plasma Glucose
|
-0.6 mmol/L
Standard Error 0.12
|
-0.78 mmol/L
Standard Error 0.12
|
0.24 mmol/L
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=65 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=68 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=66 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Insulin
|
-114.91 pmol/L
Standard Error 11.75
|
-118.66 pmol/L
Standard Error 11.66
|
-35.7 pmol/L
Standard Error 11.6
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=63 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=64 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=65 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in HOMA Index
|
-5.46 index
Standard Error 0.58
|
-5.79 index
Standard Error 0.58
|
-1.47 index
Standard Error 0.57
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in HbA1c
|
-0.41 percentage
Standard Error 0.05
|
-0.38 percentage
Standard Error 0.05
|
0.07 percentage
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=73 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Total Cholesterol
|
-0.07 mmol/L
Standard Error 0.07
|
-0.02 mmol/L
Standard Error 0.08
|
0.01 mmol/L
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=71 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=73 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change of HDL-Cholesterol
|
0.11 mmol/L
Standard Error 0.02
|
0.16 mmol/L
Standard Error 0.02
|
0.01 mmol/L
Standard Error 0.02
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=73 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=71 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=69 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change of LDL-Cholesterol
|
0.03 mmol/L
Standard Error 0.07
|
0.03 mmol/L
Standard Error 0.07
|
0.01 mmol/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=74 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=71 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Triglycerides
|
-0.44 mmol/L
Standard Error 0.09
|
-0.49 mmol/L
Standard Error 0.09
|
0.06 mmol/L
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=73 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=72 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Apo A1
|
-4.39 mg/dL
Standard Error 2.16
|
-0.29 mg/dL
Standard Error 2.19
|
0.03 mg/dL
Standard Error 2.18
|
SECONDARY outcome
Timeframe: 24 weeksAbsolute change is defined as Week 24 value - baseline value. Baseline value was defined as the last available non-missing data before or equal to the treatment start. Only fasting values were considered.
Outcome measures
| Measure |
IVA337 1200mg
n=73 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=66 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=72 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Absolute Change in Adiponectin
|
17.12 microgram/mL
Standard Error 1.44
|
11.95 microgram/mL
Standard Error 1.51
|
-0.35 microgram/mL
Standard Error 1.44
|
SECONDARY outcome
Timeframe: From baseline to Week 24.Resolution of NASH is defined as a CRN Inflammation score equel to 0 or 1, and a CRN ballooning score equal to 0. Improvement of firbosis is defined as a decrease of at least one stage in CRN Fibrosis score.
Outcome measures
| Measure |
IVA337 1200mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 Participants
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 Participants
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage
Yes
|
26 Participants
|
17 Participants
|
6 Participants
|
|
Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage
No
|
57 Participants
|
66 Participants
|
75 Participants
|
Adverse Events
IVA337 1200mg
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
IVA337 800mg
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IVA337 1200mg
n=83 participants at risk
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 participants at risk
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 participants at risk
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
2.4%
2/83 • Number of events 2 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/81 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/81 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Cardiac disorders
Angina unstable
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/81 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Hepatobiliary disorders
Pneumobilia
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Musculoskeletal and connective tissue disorders
Undifferentiated connective tissue disease
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/81 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Surgical and medical procedures
Foot operation
|
1.2%
1/83 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/83 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
Other adverse events
| Measure |
IVA337 1200mg
n=83 participants at risk
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 1200mg
|
IVA337 800mg
n=83 participants at risk
IVA337 400mg, once a day (Quaque Die, QD) with food
IVA337: 800mg
|
Placebo
n=81 participants at risk
Placebo to match, once a day (Quaque Die, QD) with food
Placebo: Placebo to match
|
|---|---|---|---|
|
Investigations
Weight increased
|
8.4%
7/83 • Number of events 7 • On or after the first dose of treatment up to 30 days post last dose.
|
9.6%
8/83 • Number of events 8 • On or after the first dose of treatment up to 30 days post last dose.
|
0.00%
0/81 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Investigations
Transaminases increased
|
3.6%
3/83 • Number of events 3 • On or after the first dose of treatment up to 30 days post last dose.
|
6.0%
5/83 • Number of events 5 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/81 • Number of events 1 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Nervous system disorders
Headache
|
8.4%
7/83 • Number of events 7 • On or after the first dose of treatment up to 30 days post last dose.
|
4.8%
4/83 • Number of events 6 • On or after the first dose of treatment up to 30 days post last dose.
|
4.9%
4/81 • Number of events 5 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Nervous system disorders
Dizziness
|
7.2%
6/83 • Number of events 6 • On or after the first dose of treatment up to 30 days post last dose.
|
2.4%
2/83 • Number of events 3 • On or after the first dose of treatment up to 30 days post last dose.
|
3.7%
3/81 • Number of events 3 • On or after the first dose of treatment up to 30 days post last dose.
|
|
General disorders
Fatigue
|
13.3%
11/83 • Number of events 11 • On or after the first dose of treatment up to 30 days post last dose.
|
3.6%
3/83 • Number of events 3 • On or after the first dose of treatment up to 30 days post last dose.
|
9.9%
8/81 • Number of events 8 • On or after the first dose of treatment up to 30 days post last dose.
|
|
General disorders
Oedema peripheral
|
8.4%
7/83 • Number of events 7 • On or after the first dose of treatment up to 30 days post last dose.
|
6.0%
5/83 • Number of events 5 • On or after the first dose of treatment up to 30 days post last dose.
|
2.5%
2/81 • Number of events 2 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
10/83 • Number of events 11 • On or after the first dose of treatment up to 30 days post last dose.
|
9.6%
8/83 • Number of events 8 • On or after the first dose of treatment up to 30 days post last dose.
|
1.2%
1/81 • Number of events 2 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Gastrointestinal disorders
Nausea
|
8.4%
7/83 • Number of events 7 • On or after the first dose of treatment up to 30 days post last dose.
|
9.6%
8/83 • Number of events 8 • On or after the first dose of treatment up to 30 days post last dose.
|
3.7%
3/81 • Number of events 3 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
5/83 • Number of events 5 • On or after the first dose of treatment up to 30 days post last dose.
|
3.6%
3/83 • Number of events 3 • On or after the first dose of treatment up to 30 days post last dose.
|
7.4%
6/81 • Number of events 6 • On or after the first dose of treatment up to 30 days post last dose.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.6%
3/83 • Number of events 5 • On or after the first dose of treatment up to 30 days post last dose.
|
3.6%
3/83 • Number of events 4 • On or after the first dose of treatment up to 30 days post last dose.
|
6.2%
5/81 • Number of events 5 • On or after the first dose of treatment up to 30 days post last dose.
|
Additional Information
Dr Michael Cooreman, Chief Medical Officer
Inventiva S.A.
Phone: +33380447616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place