Trial Outcomes & Findings for Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway (NCT NCT05194124)
NCT ID: NCT05194124
Last Updated: 2024-11-26
Results Overview
Maximum drug concentration determined directly from individual concentration-time data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1
Results posted on
2024-11-26
Participant Flow
A total of 20 participants were screened and 19 were randomized and treated in this study. The study consisted of a run-in period of up to 1 week in which the participants received once daily (QD) setmelanotide \[2 milligrams (mg), 2.5 mg, or 3 mg\]; a 13-week double-blind period in which the participants were randomized to either QD or once weekly (QW) setmelanotide; and a 13-week non-randomized open-label period where all participants received open label QW setmelanotide.
Participant milestones
| Measure |
Run-in Period: Setmelanotide 2 mg QD
Participants received subcutaneous (SC) injection of 2 mg setmelanotide QD for 1 week in the run-in period.
|
Run-in Period: Setmelanotide 2.5 mg QD
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week in the run-in period.
|
Run-in Period: Setmelanotide 3 mg QD
Participants received SC injection of 3 mg setmelanotide QD for 1 week in the run-in period.
|
DB Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period, received SC injection of 20 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Run-in Period (1 Week)
STARTED
|
2
|
1
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-in Period (1 Week)
COMPLETED
|
2
|
1
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-in Period (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (DB) Period (13 Weeks)
STARTED
|
0
|
0
|
0
|
2
|
1
|
9
|
7
|
0
|
0
|
0
|
|
Double Blind (DB) Period (13 Weeks)
COMPLETED
|
0
|
0
|
0
|
1
|
1
|
7
|
7
|
0
|
0
|
0
|
|
Double Blind (DB) Period (13 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Open Label (OL) Period (13 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
14
|
|
Open Label (OL) Period (13 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
13
|
|
Open Label (OL) Period (13 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Run-in Period: Setmelanotide 2 mg QD
Participants received subcutaneous (SC) injection of 2 mg setmelanotide QD for 1 week in the run-in period.
|
Run-in Period: Setmelanotide 2.5 mg QD
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week in the run-in period.
|
Run-in Period: Setmelanotide 3 mg QD
Participants received SC injection of 3 mg setmelanotide QD for 1 week in the run-in period.
|
DB Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period, received SC injection of 20 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double Blind (DB) Period (13 Weeks)
Withdrawal by parent/guardian
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Open Label (OL) Period (13 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
Baseline characteristics by cohort
| Measure |
Setmelanotide 2 mg QD
n=2 Participants
Run-in Period: Participants received SC injection of 2 mg setmelanotide QD for 1 week.
DB Period: Participants received SC injection of 20 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks.
OL Period: Participants received SC injection of 20 mg setmelanotide QW for 13 weeks.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Run-in Period: Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
DB Period: Participants received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks.
OL Period: Participants received SC injection of 25 mg setmelanotide QW for 13 weeks.
|
Setmelanotide 3 mg QD
n=16 Participants
Run-in Period: Participants received SC injection of 3 mg setmelanotide QD for 1 week.
DB Period: Participants received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW or 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks.
OL Period: Participants received SC injection of 30 mg setmelanotide QW for 13 weeks.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.0 years
STANDARD_DEVIATION 12.73 • n=5 Participants
|
19.0 years
n=7 Participants
|
20.8 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
20.6 years
STANDARD_DEVIATION 8.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1Population: Participants in the Pharmacokinetic Analysis Set (PKAS) (all participants who received at least 1 dose of setmelanotide and who had a sufficient number of measurable plasma concentrations to permit assessment of noncompartmental parameters) with available data were analyzed.
Maximum drug concentration determined directly from individual concentration-time data.
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=2 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=16 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in Period
|
29.4 nanograms per milliliter (ng/mL)
Standard Deviation 3.49
|
44.8 nanograms per milliliter (ng/mL)
|
59.9 nanograms per milliliter (ng/mL)
Standard Deviation 29.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14Population: Participants in the PKAS with available data were analyzed.
Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=7 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of Setmelanotide After QW Administration
|
22.4 ng/mL
|
32.7 ng/mL
|
31.8 ng/mL
Standard Deviation 28.6
|
57.3 ng/mL
Standard Deviation 33.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1Population: Participants in the PKAS with available data were analyzed.
Maximum drug concentration determined directly from individual concentration-time data.
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=2 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=16 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Setmelanotide After QD Administration in the Run-in Period
|
6.91 hours
Interval 5.92 to 7.9
|
5.88 hours
|
6.02 hours
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14Population: Participants in the PKAS with available data were analyzed.
Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=7 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of Setmelanotide After QW Administration
|
3.93 hours
|
5.93 hours
|
1.98 hours
Interval 0.5 to 6.0
|
5.95 hours
Interval 2.03 to 6.03
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes predose at Week 1Population: Participants in the PKAS with available data were analyzed.
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=2 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=9 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1
|
5.17 ng/mL
Standard Deviation 0.856
|
4.36 ng/mL
|
11.7 ng/mL
Standard Deviation 13.5
|
16.6 ng/mL
Standard Deviation 16.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes predose at Week 5Population: Participants in the PKAS with available data were analyzed.
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=7 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Setmelanotide Ctrough After QD or QW Administration at Week 5
|
—
|
9.54 ng/mL
|
12.2 ng/mL
Standard Deviation 7.62
|
15.6 ng/mL
Standard Deviation 13.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes predose at Week 9Population: Participants in the PKAS with available data were analyzed.
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=7 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=6 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Setmelanotide Ctrough After QD or QW Administration at Week 9
|
11.1 ng/mL
|
6.43 ng/mL
|
12.3 ng/mL
Standard Deviation 11.4
|
20.1 ng/mL
Standard Deviation 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes predose at Week 18Population: Participants in the PKAS with available data were analyzed.
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=6 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=6 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Setmelanotide Ctrough After QD or QW Administration at Week 18
|
14.4 ng/mL
|
12.6 ng/mL
|
13.6 ng/mL
Standard Deviation 13.9
|
26.2 ng/mL
Standard Deviation 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes predose at Week 22Population: Participants in the PKAS with available data were analyzed.
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=6 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Setmelanotide Ctrough After QD or QW Administration at Week 22
|
11.9 ng/mL
|
14.3 ng/mL
|
17.0 ng/mL
Standard Deviation 15.4
|
27.9 ng/mL
Standard Deviation 25.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 30 minutes predose at Week 27Population: Participants in the PKAS with available data were analyzed.
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=6 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Setmelanotide Ctrough After QD or QW Administration at Week 27
|
14.2 ng/mL
|
9.91 ng/mL
|
20.3 ng/mL
Standard Deviation 19.4
|
32.1 ng/mL
Standard Deviation 23.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, and 8 hours postdose at Week -1Population: Participants in the PKAS with available data were analyzed.
AUC0-tau was recorded from collected blood samples.
Outcome measures
| Measure |
Setmelanotide 2 mg QD
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=7 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of Setmelanotide After QD Administration in the Run-in Period
|
—
|
—
|
975 hours*ng/mL
Standard Deviation 659
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour) and 0.5, 1, 2, 6, 8, 12, 24, 48, 72, 96, 120, and 168-hours postdose at Week 14Population: Participants in the PKAS with available data were analyzed.
AUC0-tau was recorded from collected blood samples. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=6 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=6 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-tau of Setmelanotide After QD Administration in the Run-in Period
|
1590 hours*mg/mL
|
2260 hours*mg/mL
|
2470 hours*mg/mL
Standard Deviation 2890
|
5010 hours*mg/mL
Standard Deviation 4000
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug administration up to Week 30Population: Participants in the Safety Analysis Set (all participants who received at least 1 dose of protocol-specified study drug) were analyzed.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The AEs reported after the start of the run-in period were considered TEAEs.
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=2 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=16 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=2 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
n=1 Participants
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
n=9 Participants
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
n=1 Participants
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
n=1 Participants
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
n=14 Participants
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 13Population: Participants in the Safety Analysis Set with available data were analyzed.
The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Baseline was defined as the last available measurement prior to the first dose of setmelanotide or placebo. Injection site reactions frequency of once daily (QD) and once weekly (QW) were reported. Data are reported by dose level (treatment regimen) in the DB Period. Number of participants with injection site reactions according to severity were reported.
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=2 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=9 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
n=7 Participants
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QW · Mild
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QW · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QD · None
|
2 Participants
|
1 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QD · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QW · None
|
2 Participants
|
1 Participants
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QW · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Edema QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QD · None
|
1 Participants
|
1 Participants
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QD · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QW · None
|
1 Participants
|
0 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QW · Mild
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Induration QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QD · None
|
2 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QD · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QW · None
|
2 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QW · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Itching QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QD · None
|
2 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QD · Mild
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QW · None
|
2 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QW · Mild
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Pain or Tenderness QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QD · None
|
1 Participants
|
1 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QD · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QW · None
|
0 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QW · Mild
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Other QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QD · None
|
2 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QD · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
Erythema QW · None
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 14 through Week 27Population: Participants in the Safety Analysis Set with available data were analyzed.
The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Injection site reactions frequency of QD and QW were reported. Data are reported by dose level (treatment regimen) in the OL Period. Number of participants with injection site reactions according to severity were reported.
Outcome measures
| Measure |
Setmelanotide 2 mg QD
n=1 Participants
Participants received SC injection of 2 mg setmelanotide QD for 1 week.
|
Setmelanotide 2.5 mg QD
n=1 Participants
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
|
Setmelanotide 3 mg QD
n=14 Participants
Participants received SC injection of 3 mg setmelanotide QD for 1 week.
|
Setmelanotide 30 mg QW (QD-QW-QW)
Participants who received 3 mg setmelanotide QD in the run-in period and 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
DB Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
Participants who received 3 setmelanotide QD in the run-in period and 3 mg setmelanotide QD or 30 mg setmelanotide QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QD · None
|
1 Participants
|
1 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QD · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QW · None
|
1 Participants
|
0 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QW · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Erythema QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QD · None
|
1 Participants
|
1 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QD · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QW · None
|
1 Participants
|
1 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QW · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Edema QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QD · None
|
1 Participants
|
1 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QD · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QW · None
|
0 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QW · Mild
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QW · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Induration QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QD · None
|
1 Participants
|
1 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QD · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QW · None
|
1 Participants
|
1 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QW · Mild
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Itching QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QD · None
|
1 Participants
|
1 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QD · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QD · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QD · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QW · None
|
1 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QW · Mild
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QW · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With ISRs From Week 14 Through Week 27
Pain or Tenderness QW · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Run-in Period: Setmelanotide 2 mg QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Run-in Period: Setmelanotide 2.5 mg QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Run-in Period: Setmelanotide 3 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DB Period: Setmelanotide 20 mg QW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DB Period: Setmelanotide 25 mg QW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DB Period: Setmelanotide 3 mg QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
DB Period: Setmelanotide 30 mg QW
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OL Period: Setmelanotide 20 mg QW
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OL Period: Setmelanotide 25 mg QW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
OL Period: Setmelanotide 30 mg QW
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Run-in Period: Setmelanotide 2 mg QD
n=2 participants at risk
Participants received SC injection of 2 mg setmelanotide QD for 1 week in the run-in period.
|
Run-in Period: Setmelanotide 2.5 mg QD
n=1 participants at risk
Participants received SC injection of 2.5 mg setmelanotide QD for 1 week in the run-in period.
|
Run-in Period: Setmelanotide 3 mg QD
n=16 participants at risk
Participants received SC injection of 3 mg setmelanotide QD for 1 week in the run-in period.
|
DB Period: Setmelanotide 20 mg QW
n=2 participants at risk
Participants who received 2 mg setmelanotide QD in the run-in period, received SC injection of 20 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 25 mg QW
n=1 participants at risk
Participants who received 2.5 mg setmelanotide QD in the run-in period, received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
DB Period: Setmelanotide 3 mg QD
n=9 participants at risk
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW for 13 weeks in the DB period.
|
DB Period: Setmelanotide 30 mg QW
n=7 participants at risk
Participants who received 3 mg setmelanotide QD in the run-in period, received SC injection of 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks in the DB period.
|
OL Period: Setmelanotide 20 mg QW
n=1 participants at risk
Participants who received 2 mg setmelanotide QD in the run-in period and 20 mg setmelanotide QW in the DB period, received SC injection of 20 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 25 mg QW
n=1 participants at risk
Participants who received 2.5 mg setmelanotide QD in the run-in period and 25 mg setmelanotide QW in the DB period, received SC injection of 25 mg setmelanotide QW for 13 weeks in the OL period.
|
OL Period: Setmelanotide 30 mg QW
n=14 participants at risk
Participants who received 3 setmelanotide QD in the run-in period and 30 mg setmelanotide QD or QW in the DB period, received SC injection of 30 mg setmelanotide QW for 13 weeks in the OL period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
22.2%
2/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
50.0%
1/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site inflammation
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
6.2%
1/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
50.0%
1/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
44.4%
4/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
28.6%
2/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
44.4%
4/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
71.4%
5/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site induration
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
50.0%
1/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
22.2%
2/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
28.6%
2/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
50.0%
1/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
28.6%
2/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site mass
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
42.9%
3/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
2/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
22.2%
2/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
2/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
33.3%
3/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
22.2%
2/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
22.2%
2/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
22.2%
2/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
7.1%
1/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
14.3%
1/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
100.0%
1/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Immune system disorders
Food allergy
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/16 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/2 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
11.1%
1/9 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/7 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/1 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
0.00%
0/14 • From first dose of study drug administration up to week 30
Safety Analysis Set included all participants who received at least 1 dose of protocol-specified study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place