Trial Outcomes & Findings for A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD (NCT NCT05281328)
NCT ID: NCT05281328
Last Updated: 2026-06-01
Results Overview
Magnetic resonance imaging (MRI) was used to measure the total liver volume (TLV) at baseline and at Week 53 and was adjusted to the participant's height. The change from baseline to Week 53 was calculated as the difference between htTLV values at Week 53 and baseline. The difference in treatment effect between the groups was presented as a ratio expressed in percentage.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2/PHASE3
Target enrollment
71 participants
Primary outcome timeframe
From screening until treatment week 53
Results posted on
2026-06-01
Participant Flow
Participant milestones
| Measure |
CAM2029 Once Every 2 Weeks
0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)
|
Placebo
0.5 mL placebo, SC injection, once weekly
|
CAM2029 Once Weekly
0.5 mL CAM2029 10 mg, (SC) injection, once weekly
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
24
|
|
Overall Study
COMPLETED
|
22
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
CAM2029 Once Every 2 Weeks
0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)
|
Placebo
0.5 mL placebo, SC injection, once weekly
|
CAM2029 Once Weekly
0.5 mL CAM2029 10 mg, (SC) injection, once weekly
|
|---|---|---|---|
|
Overall Study
Assigned but not dosed
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Accessed alternative treatment
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Baseline MRI scan was missing for 4 participants.
Baseline characteristics by cohort
| Measure |
CAM2029 Once Weekly
n=24 Participants
0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly
|
CAM2029 Once Every 2 Weeks
n=24 Participants
0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)
|
Placebo
n=23 Participants
0.5 mL placebo, SC injection, once weekly
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 7.58 • n=24 Participants
|
53.8 years
STANDARD_DEVIATION 8.89 • n=24 Participants
|
52.6 years
STANDARD_DEVIATION 9.95 • n=23 Participants
|
54.1 years
STANDARD_DEVIATION 8.82 • n=71 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
21 Participants
n=23 Participants
|
61 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
10 Participants
n=71 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=71 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
20 Participants
n=23 Participants
|
66 Participants
n=71 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
4 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
66 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=71 Participants
|
|
Height-adjusted total liver volume (htTLV)
|
3358.25 mL/m
STANDARD_DEVIATION 1485.902 • n=23 Participants • Baseline MRI scan was missing for 4 participants.
|
3751.61 mL/m
STANDARD_DEVIATION 2157.086 • n=23 Participants • Baseline MRI scan was missing for 4 participants.
|
3307.39 mL/m
STANDARD_DEVIATION 1416.370 • n=21 Participants • Baseline MRI scan was missing for 4 participants.
|
3477.34 mL/m
STANDARD_DEVIATION 1713.252 • n=67 Participants • Baseline MRI scan was missing for 4 participants.
|
PRIMARY outcome
Timeframe: From screening until treatment week 53Population: Participants were randomized to three treatment groups: CAM2029 10 mg Q1W, CAM2029 10 mg Q2W, or Placebo. The primary outcome comparison was the average effect of the two CAM2029 doses (i.e., the combined CAM2029 groups) compared to placebo. The intention-to-treat analysis set (all participants randomized to a treatment arm in the double-blind period) was used for the analysis. The baseline MRI scan was missing for 4 participants (1 in each CAM2029 separate group and 2 in the placebo group).
Magnetic resonance imaging (MRI) was used to measure the total liver volume (TLV) at baseline and at Week 53 and was adjusted to the participant's height. The change from baseline to Week 53 was calculated as the difference between htTLV values at Week 53 and baseline. The difference in treatment effect between the groups was presented as a ratio expressed in percentage.
Outcome measures
| Measure |
CAM2029
n=46 Participants
CAM2029 once weekly group + CAM2029 once every 2 weeks group.
Participants were randomized to three treatment groups, CAM2029 10 mg Q1W (24 participants), CAM2029 10 mg Q2W (24 participants), or Placebo (23 participants).
The intention-to-treat analysis set (all participants randomized to a treatment arm in the double-blind period) was used for the efficacy analyses.
The treatment groups presented for the efficacy analysis (CAM2029 and placebo groups) differ from those in the Participant Flow (CAM2029 once weekly group, CAM2029 once every 2 weeks group, and placebo group) as the primary outcome is defined as the average effect of the two CAM2029 doses (i.e., the combined CAM2029 groups, i.e., 48 participants in total) compared to placebo.
|
Placebo
n=21 Participants
0.5 mL placebo, SC injection, once weekly
|
|---|---|---|
|
Height-adjusted Total Liver Volume (htTLV)
|
-0.7 percentage
Interval -2.9 to 1.6
|
3.9 percentage
Interval 0.1 to 7.7
|
SECONDARY outcome
Timeframe: From screening to Week 53Change from baseline to Week 53 in the PLD-S measure score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening until treatment weeks 13, 25, 77, 125 and 173Change from baseline in htTLV as determined by MRI volumetry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173Change from baseline in the PLD-S measure score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening until treatment weeks 13, 25, 53, 77, 125 and 173Change from baseline in htTKV as determined by MRI volumetry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening to treatment weeks 13, 25, 53, 77, 125 and 173Change from baseline in total liver cyst volume determined by MRI volumetry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173Change from baseline in eGFR, assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation using serum concentrations of creatinine and cystatin C
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173Change from baseline in the PLD-I measure score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173Change from baseline in the CGI-S score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173Change from baseline in the PGI-S score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173Change from baseline in the PGI-C score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173Change from baseline in the SF-36 score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173Change from baseline in the PLD-Q score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening to the safety follow-up, assessed up to approximately 47 months.Incidence of AEs
Outcome measures
Outcome data not reported
Adverse Events
CAM2029 Once Weekly
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
CAM2029 Once Every 2 Weeks
Serious events: 3 serious events
Other events: 21 other events
Deaths: 1 deaths
Placebo
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAM2029 Once Weekly
n=24 participants at risk
0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly
|
CAM2029 Once Every 2 Weeks
n=23 participants at risk
0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)
|
Placebo
n=23 participants at risk
0.5 mL placebo, SC injection, once weekly
|
|---|---|---|---|
|
Infections and infestations
Bacterial pyelonephritis
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Pyelonephritis acute
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Renal cyst infection
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Congenital, familial and genetic disorders
Polycystic liver disease
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Hepatobiliary disorders
Hepatic cyst ruptured
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Renal and urinary disorders
Hydronephrosis
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
Other adverse events
| Measure |
CAM2029 Once Weekly
n=24 participants at risk
0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly
|
CAM2029 Once Every 2 Weeks
n=23 participants at risk
0.5 mL CAM2029 10 mg, SC injection,every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)
|
Placebo
n=23 participants at risk
0.5 mL placebo, SC injection, once weekly
|
|---|---|---|---|
|
General disorders
Malaise
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Constipation
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
30.4%
7/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
18/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
60.9%
14/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
30.4%
7/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Abdominal pain
|
41.7%
10/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
30.4%
7/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
26.1%
6/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Nausea
|
29.2%
7/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
26.1%
6/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Abdominal distension
|
20.8%
5/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
34.8%
8/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Steatorrhoea
|
25.0%
6/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Faeces pale
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Faeces discoloured
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Abnormal faeces
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site pain
|
45.8%
11/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
34.8%
8/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
60.9%
14/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Fatigue
|
20.8%
5/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Pyrexia
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Chills
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Pain
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
COVID-19
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Urinary tract infection
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Sinusitis
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
4/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
4/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Nervous system disorders
Headache
|
29.2%
7/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Nervous system disorders
Dizziness
|
20.8%
5/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
4/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Investigations
Blood cholesterol increased
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Vascular disorders
Hypertension
|
16.7%
4/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
4/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site pruritus
|
50.0%
12/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
34.8%
8/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
34.8%
8/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site mass
|
25.0%
6/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
30.4%
7/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
30.4%
7/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site bruising
|
25.0%
6/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
26.1%
6/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site erythema
|
33.3%
8/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
21.7%
5/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site induration
|
16.7%
4/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
17.4%
4/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site swelling
|
20.8%
5/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site discolouration
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site granuloma
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site rash
|
4.2%
1/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
13.0%
3/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site inflammation
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Influenza like illness
|
12.5%
3/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Injection site nodule
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
General disorders
Oedema peripheral
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Infections and infestations
Pyelonephritis
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Nervous system disorders
Dysgeusia
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Investigations
Weight decreased
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Investigations
Blood pressure systolic increased
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Vascular disorders
Hypotension
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
4.3%
1/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
8.7%
2/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
|
Gastrointestinal disorders
Proctalgia
|
8.3%
2/24 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
0.00%
0/23 • From screening to the safety follow-up, assessed up to approximately 43 months
Safety analysis set (all participants who were administered at least 1 dose of IMP during the double-blind treatment period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place