Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis (NCT NCT04171765)
NCT ID: NCT04171765
Last Updated: 2024-04-16
Results Overview
Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Week 52
Results posted on
2024-04-16
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose 50 mg
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 75 mg
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 100 mg
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose 50 mg
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 75 mg
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 100 mg
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
2
|
|
Overall Study
Week 58 visit missed
|
0
|
0
|
1
|
0
|
|
Overall Study
Study terminated by sponsor
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose 50 mg
n=11 Participants
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 75 mg
n=11 Participants
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 100 mg
n=11 Participants
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.4 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
57.4 Years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
55.4 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
51.9 Years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
53.0 Years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The modified intent-to-treat (mITT) population was defined as all randomly allocated participants who received at least one dose of study drug or placebo.
Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose 50 mg
n=8 Participants
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 75 mg
n=7 Participants
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 100 mg
n=6 Participants
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
|
16.7 Percentage of Participants
Interval 0.0 to 54.82
|
37.5 Percentage of Participants
Interval 0.0 to 77.3
|
14.3 Percentage of Participants
Interval 0.0 to 47.35
|
33.3 Percentage of Participants
Interval 0.0 to 79.39
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 52Population: The mITT population was defined as all randomly allocated participants who received at least one dose of study drug or placebo.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose 50 mg
n=11 Participants
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 75 mg
n=11 Participants
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 100 mg
n=11 Participants
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
Baseline
|
20.15 percentage of hepatic fat fraction
Standard Deviation 6.35
|
20.67 percentage of hepatic fat fraction
Standard Deviation 6.05
|
19.30 percentage of hepatic fat fraction
Standard Deviation 3.99
|
18.12 percentage of hepatic fat fraction
Standard Deviation 7.70
|
|
Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
Week 16 change from baseline
|
-3.47 percentage of hepatic fat fraction
Standard Deviation 2.28
|
-8.20 percentage of hepatic fat fraction
Standard Deviation 8.58
|
-2.23 percentage of hepatic fat fraction
Standard Deviation 9.05
|
-10.25 percentage of hepatic fat fraction
Standard Deviation 4.76
|
|
Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
Week 52 change from baseline
|
-4.46 percentage of hepatic fat fraction
Standard Deviation 6.23
|
-2.50 percentage of hepatic fat fraction
Standard Deviation 8.13
|
-3.46 percentage of hepatic fat fraction
Standard Deviation 11.57
|
-3.53 percentage of hepatic fat fraction
Standard Deviation 6.54
|
SECONDARY outcome
Timeframe: Week 52Population: The mITT population was defined as all randomly allocated participants who received at least one dose of study drug or placebo.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose 50 mg
n=8 Participants
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 75 mg
n=7 Participants
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 100 mg
n=6 Participants
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52
|
16.7 Percentage of participants
Interval 0.0 to 54.82
|
37.5 Percentage of participants
Interval 0.0 to 77.3
|
42.9 Percentage of participants
Interval 0.0 to 86.66
|
33.3 Percentage of participants
Interval 0.0 to 79.39
|
SECONDARY outcome
Timeframe: Week 52Population: The mITT population was defined as all randomly allocated participants who received at least one dose of study drug or placebo.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose 50 mg
n=8 Participants
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 75 mg
n=7 Participants
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose 100 mg
n=6 Participants
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52
|
16.7 Percentage of participants
Interval 0.0 to 54.82
|
25.0 Percentage of participants
Interval 0.0 to 61.26
|
28.6 Percentage of participants
Interval 0.0 to 69.18
|
16.7 Percentage of participants
Interval 0.0 to 54.82
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Fixed Dose-50mg BFKB8488A
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Fixed Dose-75mg BFKB8488A
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Fixed Dose-100mg BFKB8488A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose-50mg BFKB8488A
n=11 participants at risk
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose-75mg BFKB8488A
n=11 participants at risk
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose-100mg BFKB8488A
n=11 participants at risk
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
Participants received placebo by subcutaneous (SC) injection every two weeks (Q2W) for 52 weeks.
|
Fixed Dose-50mg BFKB8488A
n=11 participants at risk
Participants received 50 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose-75mg BFKB8488A
n=11 participants at risk
Participants received 75 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
Fixed Dose-100mg BFKB8488A
n=11 participants at risk
Participants received 100 mg of SC fazpilodemab (BFKB8488A) Q2W for 52 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
9.1%
1/11 • Number of events 3 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
General disorders
Administration site pain
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Administration site swelling
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Chest pain
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
General disorders
Chills
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
18.2%
2/11 • Number of events 4 • Through Week 58
|
|
General disorders
Early satiety
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Fatigue
|
15.4%
2/13 • Number of events 2 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
General disorders
Injection site bruising
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 2 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Injection site erythema
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Injection site pain
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 3 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Injection site swelling
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
General disorders
Injection site urticaria
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Eye disorders
Cataract
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Eye disorders
Retinal tear
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 4 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
18.2%
2/11 • Number of events 3 • Through Week 58
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 2 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Through Week 58
|
27.3%
3/11 • Number of events 5 • Through Week 58
|
27.3%
3/11 • Number of events 4 • Through Week 58
|
36.4%
4/11 • Number of events 4 • Through Week 58
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 3 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 3 • Through Week 58
|
27.3%
3/11 • Number of events 5 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
45.5%
5/11 • Number of events 12 • Through Week 58
|
|
Gastrointestinal disorders
Toothache
|
15.4%
2/13 • Number of events 2 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
General disorders
Vaccination site pain
|
7.7%
1/13 • Number of events 2 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Infections and infestations
COVID-19
|
15.4%
2/13 • Number of events 2 • Through Week 58
|
45.5%
5/11 • Number of events 5 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
Infections and infestations
Cellulitis
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Infections and infestations
Tooth infection
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Blood iron decreased
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Blood pressure increased
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Cortisol free urine increased
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Insulin-like growth factor decreased
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Investigations
Weight decreased
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Investigations
Weight increased
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
27.3%
3/11 • Number of events 4 • Through Week 58
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Metabolism and nutrition disorders
Increased appetite
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 2 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
27.3%
3/11 • Number of events 3 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Nervous system disorders
Carpal tunnel syndrome
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Nervous system disorders
Neuralgia
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 2 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Respiratory, thoracic and mediastinal disorders
Nasal valve collapse
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Through Week 58
|
18.2%
2/11 • Number of events 2 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
1/13 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 3 • Through Week 58
|
|
Vascular disorders
Hot flush
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 2 • Through Week 58
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
9.1%
1/11 • Number of events 1 • Through Week 58
|
0.00%
0/11 • Through Week 58
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER