Trial Outcomes & Findings for A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany (NCT NCT05305664)

Last Updated: 2026-07-17

Results Overview

Rate (proportion) of apheresis sessions was calculated as the number of actual lipoprotein apheresis (LA) sessions received, divided by the number of planned LA sessions during the 52-week period, which is 52 for patients who completed all study visits, or pro-rated for those who discontinued early. This rate could range from 0 to 1, with 0 indicating that the patient had skipped all planned LA sessions, and 1 indicating that the patient had received all planned sessions. Multiple imputation for missing Lp(a) data was performed, and missing apheresis data was imputed.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

Up to Week 52

Results posted on

2026-07-17

Participant Flow

A total of 51 participants were recruited in 13 centers across Germany

60 participants were screened and 51 randomized. There was a 14 day screening period before treatment at baseline.

Participant milestones

Participant milestones
Measure	Pelacarsen (TQJ230) Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo Placebo to Pelacarsen s.c. Q4W
Overall Study STARTED	26	25
Overall Study COMPLETED	25	23
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pelacarsen (TQJ230) Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo Placebo to Pelacarsen s.c. Q4W
Overall Study Adverse Event	0	1
Overall Study Death	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W	Total n=51 Participants Total of all reporting groups
Race/Ethnicity, Customized Ethnicity · Not hispanic or latino	26 Participants n=20 Participants	25 Participants n=20 Participants	51 Participants n=40 Participants
Participants with prior clinically significant symptomatic coronary artery disease	1 Participants n=20 Participants	3 Participants n=20 Participants	4 Participants n=40 Participants
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=20 Participants	15 Participants n=20 Participants	30 Participants n=40 Participants
Age, Categorical >=65 years	11 Participants n=20 Participants	10 Participants n=20 Participants	21 Participants n=40 Participants
Age, Continuous	62.0 years STANDARD_DEVIATION 8.10 • n=20 Participants	61.4 years STANDARD_DEVIATION 9.35 • n=20 Participants	61.7 years STANDARD_DEVIATION 8.65 • n=40 Participants
Sex: Female, Male Female	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Sex: Female, Male Male	20 Participants n=20 Participants	19 Participants n=20 Participants	39 Participants n=40 Participants
Race/Ethnicity, Customized Race · White	26 Participants n=20 Participants	25 Participants n=20 Participants	51 Participants n=40 Participants
Participants with prior miocardial infarction	21 Participants n=20 Participants	19 Participants n=20 Participants	40 Participants n=40 Participants
Participants with prior ischemic stroke	1 Participants n=20 Participants	5 Participants n=20 Participants	6 Participants n=40 Participants
Participants with prior peripheral artery disease	5 Participants n=20 Participants	5 Participants n=20 Participants	10 Participants n=40 Participants
Qualifying events Prior myocardial infarction only	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Qualifying events Prior ischemic stroke only	0 Participants n=20 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants
Qualifying events Prior peripheral artery disease only	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Qualifying events Prior clinically significant symptomatic CAD only	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Qualifying events Subjects with more than one qualifying event	24 Participants n=20 Participants	21 Participants n=20 Participants	45 Participants n=40 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: The full analysis set (FAS) consists of all randomized participants with the exception of those participants who have not been qualified for randomization and have not received study treatment but have been inadvertently randomized into the study.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule	0.16 Apheresis sessions received per week Interval 0.04 to 0.25	0.93 Apheresis sessions received per week Interval 0.9 to 1.0

SECONDARY outcome

Timeframe: From randomization up to Week 52

Lipoprotein apheresis avoidance is defined as at least 24 consecutive weeks of no lipoprotein apheresis until end of study.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Time to Lipoprotein Apheresis Avoidance	6.14 weeks Interval 3.14 to 10.14	NA weeks NA: not estimable due to no participant with apheresis avoidance

SECONDARY outcome

Timeframe: Week 12 up to Week 52

Total lipoprotein apheresis avoidance is defined as no apheresis performed from Week 12 to Week 52.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Number of Participants With Total Lipoprotein Apheresis Avoidance From Week 12 to Week 52	18 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, week 52

Week 52 / Baseline ratio in Lp(a) of pelacarsen (TQJ230) vs placebo reported as particle mass (mg/dL). Baseline Lp(a) was defined as the last non-missing pre-lipoprotein apheresis assessment prior to the first dose of randomized study drug.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Change From Baseline to Week 52 in the Log-transformed Lp(a) Reported as mg/dL	0.32 ratio from baseline Interval 0.26 to 0.39	1.11 ratio from baseline Interval 0.89 to 1.38

SECONDARY outcome

Timeframe: Baseline, week 52

Week 52 / Baseline ratio in Lp(a) of pelacarsen (TQJ230) vs placebo reported as molar concentration (nmol/L). Baseline Lp(a) was defined as the last non-missing pre-lipoprotein apheresis assessment prior to the first dose of randomized study drug.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Change From Baseline to Week 52 in the Log-transformed Lp(a) Reported as Nmol/L	0.27 ratio from baseline Interval 0.21 to 0.34	1.14 ratio from baseline Interval 0.89 to 1.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12 to 52, Week 24 to 52

Rate (proportion) of apheresis sessions is calculated using the following formula: the total number of apheresis sessions performed over the double-blinded treatment period/total weeks from Week12 to Week52 or total weeks from Week24 to Week52. Multiple imputation for missing Lp(a) data was performed and missing apheresis data were imputed.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Rate of Lipoprotein Apheresis Sessions From Week 12 to Week 52 and Week 24 to Week 52 Normalized to the Weekly Lipoprotein Apheresis Schedule 12 to 52 weeks - Imputed data	0.11 Apheresis session per week Interval 0.0 to 0.1	0.93 Apheresis session per week Interval 0.88 to 1.0
Rate of Lipoprotein Apheresis Sessions From Week 12 to Week 52 and Week 24 to Week 52 Normalized to the Weekly Lipoprotein Apheresis Schedule 24 to 52 weeks - Imputed data	0.10 Apheresis session per week Interval 0.0 to 0.07	0.93 Apheresis session per week Interval 0.96 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24 to Week 52

Number of participants with no apheresis performed between week 24 to week 52.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Number of Participants With Total Lipoprotein Apheresis Avoidance From Week 24 to Week 52	19 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Time averaged Lp(a) levels were calculated as CAVG = CMIN + 0.73 × (CMAX-CMIN), where CMAX and CMIN are the immediate pre- and post-apheresis Lp(a) levels.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Time-averaged Lp(a) Levels Reported as mg/dL Baseline	75.4 mg/dL Standard Deviation 25.98	63.2 mg/dL Standard Deviation 15.89
Time-averaged Lp(a) Levels Reported as mg/dL Week 52	34.2 mg/dL Standard Deviation 32.41	73.7 mg/dL Standard Deviation 19.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Time averaged Lp(a) levels were calculated as CAVG = CMIN + 0.73 × (CMAX-CMIN), where CMAX and CMIN are the immediate pre- and post-apheresis Lp(a) levels.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=26 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=25 Participants Placebo to Pelacarsen s.c. Q4W
Time-averaged Lp(a) Levels Reported as Nmol/L Week 52	65.6 nmol/L Standard Deviation 68.05	156.2 nmol/L Standard Deviation 44.60
Time-averaged Lp(a) Levels Reported as Nmol/L Baseline	159.9 nmol/L Standard Deviation 56.67	130.1 nmol/L Standard Deviation 34.40

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: Participants in the full analysis set (FAS) with available measurements at baseline and week 52. FAS consists of all randomized participants with the exception of those participants who have not been qualified for randomization and have not received study treatment but have been inadvertently randomized into the study.

Evaluate the change in expanded lipid profile parameters measured in mg/dL

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=24 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=23 Participants Placebo to Pelacarsen s.c. Q4W
Percentage Change in Total Cholesterol, LDL-C, High-density Lipoprotein-Cholesterol (HDL-C), Non-HDL-C, Very-low-density Lipoprotein-Cholesterol (VLDL-C), apoB and Triglycerides (Pre- Lipoprotein Apheresis) From Baseline to Week 52 LDL-C	3.64 percentage change from baseline Standard Deviation 50.490	8.85 percentage change from baseline Standard Deviation 26.265
Percentage Change in Total Cholesterol, LDL-C, High-density Lipoprotein-Cholesterol (HDL-C), Non-HDL-C, Very-low-density Lipoprotein-Cholesterol (VLDL-C), apoB and Triglycerides (Pre- Lipoprotein Apheresis) From Baseline to Week 52 Total cholesterol	6.23 percentage change from baseline Standard Deviation 24.810	2.37 percentage change from baseline Standard Deviation 17.587
Percentage Change in Total Cholesterol, LDL-C, High-density Lipoprotein-Cholesterol (HDL-C), Non-HDL-C, Very-low-density Lipoprotein-Cholesterol (VLDL-C), apoB and Triglycerides (Pre- Lipoprotein Apheresis) From Baseline to Week 52 HDL-C	16.93 percentage change from baseline Standard Deviation 26.059	-2.31 percentage change from baseline Standard Deviation 13.465
Percentage Change in Total Cholesterol, LDL-C, High-density Lipoprotein-Cholesterol (HDL-C), Non-HDL-C, Very-low-density Lipoprotein-Cholesterol (VLDL-C), apoB and Triglycerides (Pre- Lipoprotein Apheresis) From Baseline to Week 52 Non-HDL-C	1.82 percentage change from baseline Standard Deviation 42.291	6.97 percentage change from baseline Standard Deviation 22.968
Percentage Change in Total Cholesterol, LDL-C, High-density Lipoprotein-Cholesterol (HDL-C), Non-HDL-C, Very-low-density Lipoprotein-Cholesterol (VLDL-C), apoB and Triglycerides (Pre- Lipoprotein Apheresis) From Baseline to Week 52 VLDL-C	2.01 percentage change from baseline Standard Deviation 40.267	5.31 percentage change from baseline Standard Deviation 42.146
Percentage Change in Total Cholesterol, LDL-C, High-density Lipoprotein-Cholesterol (HDL-C), Non-HDL-C, Very-low-density Lipoprotein-Cholesterol (VLDL-C), apoB and Triglycerides (Pre- Lipoprotein Apheresis) From Baseline to Week 52 Triglycerides	31.60 percentage change from baseline Standard Deviation 95.892	5.08 percentage change from baseline Standard Deviation 18.62
Percentage Change in Total Cholesterol, LDL-C, High-density Lipoprotein-Cholesterol (HDL-C), Non-HDL-C, Very-low-density Lipoprotein-Cholesterol (VLDL-C), apoB and Triglycerides (Pre- Lipoprotein Apheresis) From Baseline to Week 52 Apo-B	0.95 percentage change from baseline Standard Deviation 36.488	6.70 percentage change from baseline Standard Deviation 17.652

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=25 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=24 Participants Placebo to Pelacarsen s.c. Q4W
Change From Baseline to Week 52 in the Physical Health Summary Score for the SF-36 Questionnaire Baseline	51.2 scales on a score Standard Deviation 8.06	48.3 scales on a score Standard Deviation 9.02
Change From Baseline to Week 52 in the Physical Health Summary Score for the SF-36 Questionnaire Week 52	49.4 scales on a score Standard Deviation 9.44	50.3 scales on a score Standard Deviation 6.76
Change From Baseline to Week 52 in the Physical Health Summary Score for the SF-36 Questionnaire Change from baseline to Week 52	-2.05 scales on a score Standard Deviation 6.653	0.83 scales on a score Standard Deviation 4.554

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=25 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=24 Participants Placebo to Pelacarsen s.c. Q4W
Change From Baseline to Week 52 in the Mental Health Summary Score for the SF-36 Questionnaire Baseline	53.6 scales on a score Standard Deviation 6.78	52.6 scales on a score Standard Deviation 7.21
Change From Baseline to Week 52 in the Mental Health Summary Score for the SF-36 Questionnaire Week 52	54.8 scales on a score Standard Deviation 6.09	54.8 scales on a score Standard Deviation 6.55
Change From Baseline to Week 52 in the Mental Health Summary Score for the SF-36 Questionnaire Change from baseline to Week 52	1.95 scales on a score Standard Deviation 6.436	3.67 scales on a score Standard Deviation 4.589

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Participants were asked for their treatment preference between weekly lipoprotein apheresis or monthly self-injection. The number of participants that prefer each option at baseline and 52 weeks is reported.

Outcome measures

Outcome measures
Measure	Pelacarsen (TQJ230) n=25 Participants Pelacarsen (TQJ230) 80 mg s.c. Q4W	Placebo n=24 Participants Placebo to Pelacarsen s.c. Q4W
Patient Preference Questionnaire Week 52 - Weekly apheresis	0 Participants	0 Participants
Patient Preference Questionnaire Week 52 - monthly self-injection	20 Participants	19 Participants
Patient Preference Questionnaire Baseline - Weekly apheresis	0 Participants	0 Participants
Patient Preference Questionnaire Baseline - monthly self-injection	25 Participants	24 Participants

Adverse Events

Pelacarsen

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 17 other events

Deaths: 1 deaths

Total

Serious events: 13 serious events

Other events: 40 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Pelacarsen n=26 participants at risk Pelacarsen	Placebo n=25 participants at risk Placebo	Total n=51 participants at risk Total
Infections and infestations Pneumonia	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Cardiac disorders Arrhythmia	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Cardiac disorders Coronary artery disease	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Cardiac disorders Myocardial infarction	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Gastrointestinal disorders Gastritis	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Gastrointestinal disorders Idiopathic pancreatitis	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Gastrointestinal disorders Large intestine polyp	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
General disorders and administration site conditions Disease progression	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Hepatobiliary disorders Cholecystitis acute	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Hepatobiliary disorders Cholestasis	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Injury, poisoning and procedural complications Femoral neck fracture	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Nervous system disorders Syncope	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	3.9% 2/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Vascular disorders Hypertensive crisis	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	2.0% 1/51 • From baseline to 16 weeks after last treatment up to 68 weeks.

Measure	Pelacarsen n=26 participants at risk Pelacarsen	Placebo n=25 participants at risk Placebo	Total n=51 participants at risk Total
General disorders and administration site conditions Injection site pruritus	15.4% 4/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	9.8% 5/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
General disorders and administration site conditions Injection site rash	11.5% 3/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	5.9% 3/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
General disorders and administration site conditions Pyrexia	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	3.9% 2/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Infections and infestations COVID-19	23.1% 6/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	20.0% 5/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	21.6% 11/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Infections and infestations Nasopharyngitis	23.1% 6/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	36.0% 9/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	29.4% 15/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Ear and labyrinth disorders Vertigo	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	8.0% 2/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	7.8% 4/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Gastrointestinal disorders Diarrhoea	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	5.9% 3/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
General disorders and administration site conditions Fatigue	19.2% 5/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	11.8% 6/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
General disorders and administration site conditions Influenza like illness	11.5% 3/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	5.9% 3/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
General disorders and administration site conditions Injection site erythema	38.5% 10/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	19.6% 10/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
General disorders and administration site conditions Injection site haematoma	11.5% 3/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	7.8% 4/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Infections and infestations Respiratory tract infection	19.2% 5/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	9.8% 5/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Infections and infestations Urinary tract infection	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	5.9% 3/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Investigations Blood creatinine increased	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	3.9% 2/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Metabolism and nutrition disorders Iron deficiency	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	20.0% 5/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	13.7% 7/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	11.5% 3/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	7.8% 4/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Musculoskeletal and connective tissue disorders Back pain	15.4% 4/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	8.0% 2/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	11.8% 6/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	3.9% 2/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	3.9% 2/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Nervous system disorders Dizziness	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	5.9% 3/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Nervous system disorders Headache	23.1% 6/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	11.8% 6/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Nervous system disorders Paraesthesia	0.00% 0/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	8.0% 2/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	3.9% 2/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Reproductive system and breast disorders Benign prostatic hyperplasia	3.8% 1/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	8.0% 2/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	5.9% 3/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	0.00% 0/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	3.9% 2/51 • From baseline to 16 weeks after last treatment up to 68 weeks.
Vascular disorders Hypertension	7.7% 2/26 • From baseline to 16 weeks after last treatment up to 68 weeks.	4.0% 1/25 • From baseline to 16 weeks after last treatment up to 68 weeks.	5.9% 3/51 • From baseline to 16 weeks after last treatment up to 68 weeks.