Trial Outcomes & Findings for Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH) (NCT NCT02443116)
NCT ID: NCT02443116
Last Updated: 2025-07-23
Results Overview
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
254 participants
Primary outcome timeframe
Up to Week 12
Results posted on
2025-07-23
Participant Flow
A total of 254 participants who met all inclusion criteria and no exclusion criteria were enrolled in this study. This was a 3-part study where Parts 1 and 3 were randomized, placebo controlled studies and Part 2 was an open-label study.
Participant milestones
| Measure |
Part 1: Aldafermin 3.0 mg
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 0.3 mg
Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg
Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 3.0 mg
Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Aldafermin 1.0 mg
Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Placebo
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
27
|
28
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
25
|
24
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
2
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
23
|
21
|
22
|
28
|
0
|
0
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
21
|
20
|
19
|
25
|
0
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
2
|
1
|
3
|
3
|
0
|
0
|
|
Part 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
53
|
25
|
|
Part 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
49
|
20
|
|
Part 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
5
|
Reasons for withdrawal
| Measure |
Part 1: Aldafermin 3.0 mg
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 0.3 mg
Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg
Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 3.0 mg
Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Aldafermin 1.0 mg
Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Placebo
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1
Adverse Event
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
Withdrew informed consent
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
Participant moved out of state
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
Participant enrolled in another clinical trial
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
|
Part 2
Withdrew informed consent
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Part 2
Inability to comply with protocol
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
Early end of treatment secondary to cardiac arrest and subsequently lost to follow up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 3
Withdrew informed consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Part 3
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Part 1: Aldafermin 3.0 mg
n=27 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=28 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=27 Participants
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 0.3 mg
n=23 Participants
Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg
n=21 Participants
Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 3.0 mg
n=22 Participants
Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
n=28 Participants
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Aldafermin 1.0 mg
n=53 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 6, 8, 12, 18, and 24 were self-administered in the clinic, with all other doses throughout the treatment period self-administered at home.
|
Part 3: Placebo
n=25 Participants
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 6, 8, 12, 18, and 24 were self-administered in the clinic, with all other doses throughout the treatment period self-administered at home.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
226 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
51.5 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
51.5 years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
49.8 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
53.2 years
STANDARD_DEVIATION 12.1 • n=24 Participants
|
54.1 years
STANDARD_DEVIATION 9.7 • n=42 Participants
|
51.9 years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
163 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
91 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
234 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=27 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=28 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=27 Participants
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Change in Absolute Liver Fat Content (Part 1)
|
-9.68 percent of liver fat
Standard Error 0.98
|
-11.91 percent of liver fat
Standard Error 1.00
|
-0.85 percent of liver fat
Standard Error 0.99
|
—
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=23 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=21 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=20 Participants
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
n=25 Participants
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Change in Absolute Liver Fat Content (Part 2)
|
-4.95 percent of liver fat
Standard Error 1.07
|
-10.69 percent of liver fat
Standard Error 1.09
|
-11.55 percent of liver fat
Standard Error 1.08
|
-10.85 percent of liver fat
Standard Error 1.01
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=51 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=22 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Change in Absolute Liver Fat Content (Part 3)
|
-7.70 percent of liver fat
Standard Error 0.82
|
-2.73 percent of liver fat
Standard Error 1.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Percentage change in liver fat content was assessed in the Efficacy Population.
Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=27 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=28 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=27 Participants
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Percentage Change in Liver Fat Content (Part 1)
|
-47.98 percentage change of liver fat content
Standard Error 5.79
|
-60.09 percentage change of liver fat content
Standard Error 5.92
|
-2.57 percentage change of liver fat content
Standard Error 5.85
|
—
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=23 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=21 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=20 Participants
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
n=26 Participants
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Change in Absolute Liver Fat Content (Part 2)
Week 6
|
-4.15 percent of liver fat
Standard Error 0.93
|
-8.21 percent of liver fat
Standard Error 0.97
|
-10.38 percent of liver fat
Standard Error 0.94
|
-8.36 percent of liver fat
Standard Error 0.87
|
|
Change in Absolute Liver Fat Content (Part 2)
Week 18
|
-4.51 percent of liver fat
Standard Error 1.17
|
-3.87 percent of liver fat
Standard Error 1.14
|
-7.67 percent of liver fat
Standard Error 1.15
|
-5.72 percent of liver fat
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population.
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=23 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=21 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=22 Participants
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
n=28 Participants
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Percentage Change in Liver Fat Content (Part 2)
Week 6
|
-24.95 percentage change of liver fat content
Standard Error 4.94
|
-42.90 percentage change of liver fat content
Standard Error 5.19
|
-58.72 percentage change of liver fat content
Standard Error 5.01
|
-45.92 percentage change of liver fat content
Standard Error 4.63
|
|
Percentage Change in Liver Fat Content (Part 2)
Week 12
|
-29.09 percentage change of liver fat content
Standard Error 5.32
|
-55.10 percentage change of liver fat content
Standard Error 5.42
|
-63.84 percentage change of liver fat content
Standard Error 5.41
|
-57.85 percentage change of liver fat content
Standard Error 5.04
|
|
Percentage Change in Liver Fat Content (Part 2)
Week 18
|
-22.58 percentage change of liver fat content
Standard Error 6.66
|
-17.70 percentage change of liver fat content
Standard Error 6.44
|
-40.79 percentage change of liver fat content
Standard Error 6.55
|
-29.03 percentage change of liver fat content
Standard Error 6.07
|
SECONDARY outcome
Timeframe: Up to Week 30Population: Absolute liver fat content was assessed in the Efficacy Population in participants with available data.
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=52 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=24 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Change in Absolute Liver Fat Content (Part 3)
Week 6
|
-6.54 percent of liver fat
Standard Error 0.59
|
-0.93 percent of liver fat
Standard Error 0.89
|
—
|
—
|
|
Change in Absolute Liver Fat Content (Part 3)
Week 12
|
-8.43 percent of liver fat
Standard Error 0.74
|
-1.89 percent of liver fat
Standard Error 1.14
|
—
|
—
|
|
Change in Absolute Liver Fat Content (Part 3)
Week 30
|
-3.04 percent of liver fat
Standard Error 0.77
|
-2.05 percent of liver fat
Standard Error 1.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 30Population: Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population.
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Outcome measures
| Measure |
Part 1: Aldafermin 3.0 mg
n=52 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=24 Participants
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|
|
Percentage Change in Liver Fat Content (Part 3)
Week 6
|
-36.59 percentage change of liver fat content
Standard Error 3.22
|
-2.17 percentage change of liver fat content
Standard Error 4.81
|
—
|
—
|
|
Percentage Change in Liver Fat Content (Part 3)
Week 12
|
-45.27 percentage change of liver fat content
Standard Error 4.26
|
-6.88 percentage change of liver fat content
Standard Error 6.60
|
—
|
—
|
|
Percentage Change in Liver Fat Content (Part 3)
Week 24
|
-38.76 percentage change of liver fat content
Standard Error 5.03
|
-13.10 percentage change of liver fat content
Standard Error 7.89
|
—
|
—
|
|
Percentage Change in Liver Fat Content (Part 3)
Week 30
|
-11.22 percentage change of liver fat content
Standard Error 4.91
|
-9.99 percentage change of liver fat content
Standard Error 7.59
|
—
|
—
|
Adverse Events
Part 1: Aldafermin 3.0 mg
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Part 1: Aldafermin 6.0 mg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Part 1: Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Part 2: Aldafermin 0.3 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Part 2: Aldafermin 1.0 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Part 2: Aldafermin 3.0 mg
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Part 2: Aldafermin 1.0 mg (Cohort 4)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Part 3: Aldafermin 1.0 mg
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Part 3: Placebo
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Aldafermin 3.0 mg
n=27 participants at risk
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=28 participants at risk
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=27 participants at risk
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 0.3 mg
n=23 participants at risk
Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg
n=21 participants at risk
Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 3.0 mg
n=22 participants at risk
Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
n=28 participants at risk
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Aldafermin 1.0 mg
n=53 participants at risk
Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Placebo
n=25 participants at risk
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Acute pancreatitis
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Chest pain
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Nervous system disorders
Headache
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
Other adverse events
| Measure |
Part 1: Aldafermin 3.0 mg
n=27 participants at risk
Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Aldafermin 6.0 mg
n=28 participants at risk
Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 1: Placebo
n=27 participants at risk
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 0.3 mg
n=23 participants at risk
Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg
n=21 participants at risk
Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 3.0 mg
n=22 participants at risk
Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 2: Aldafermin 1.0 mg (Cohort 4)
n=28 participants at risk
Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Aldafermin 1.0 mg
n=53 participants at risk
Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
Part 3: Placebo
n=25 participants at risk
Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Loose stools
|
25.9%
7/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
17.9%
5/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
3/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
22.7%
5/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
21.4%
6/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Nausea
|
29.6%
8/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.7%
2/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
28.6%
6/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
27.3%
6/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
42.9%
12/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.4%
5/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
24.0%
6/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.8%
4/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
3/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.1%
2/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
28.6%
8/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
28.3%
15/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
24.0%
6/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
17.9%
5/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.7%
2/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
3/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.1%
2/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
21.4%
6/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
5.7%
3/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
3/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Bloating
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
4/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
17.9%
5/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
5.7%
3/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Nausea aggravated
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Abdominal bloating
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Diarrhea aggravated
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
RUQ pain
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Soft stools
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
GERD
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.5%
4/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Increased frequency of defecation
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Stomach cramps
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Injection site erythema
|
22.2%
6/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
39.3%
11/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Injection site reaction
|
11.1%
3/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
4/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Injection site bruising
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
11.1%
3/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
5.7%
3/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Injection site pruritus
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Fatigue
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
13.0%
3/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
3/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
21.4%
6/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
5.7%
3/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
16.0%
4/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Injection site pain
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Injection site swelling
|
11.1%
3/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
17.9%
5/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
18.5%
5/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
21.7%
5/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
19.0%
4/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
18.2%
4/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
4/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
13.2%
7/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
36.0%
9/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Nervous system disorders
Dysgeusia
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
4/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.7%
2/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Sinusitis
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.5%
4/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
18.2%
4/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
17.9%
5/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Metabolism and nutrition disorders
Increased appetite
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
14.3%
4/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Investigations
Weight decreased
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
10.7%
3/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Investigations
Blood creatinine increased
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Investigations
Weight increased
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.4%
2/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.5%
4/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Abdominal cramp
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.1%
2/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.1%
2/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
5.7%
3/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Stool discoloration
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Investigations
Low density lipoprotein increased
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
39.1%
9/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
71.4%
15/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
40.9%
9/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
46.4%
13/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
18.2%
4/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
25.0%
7/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Investigations
Glycosylated hemoglobin increased
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Infections and infestations
Influenza
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.7%
2/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
19.0%
4/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
18.2%
4/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
21.4%
6/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Chest pain
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.1%
2/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.5%
4/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
18.2%
4/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.0%
1/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.7%
2/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.5%
4/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.7%
2/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
5.7%
3/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
13.2%
7/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
12.0%
3/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Oedema peripheral
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
12.0%
3/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
General disorders
Influenza like illness
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.3%
1/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.8%
2/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
20.0%
5/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.6%
1/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
4.5%
1/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
1.9%
1/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
8.0%
2/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
7.1%
2/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/27 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/23 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/22 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
0.00%
0/28 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
28.3%
15/53 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
24.0%
6/25 • Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place