Trial Outcomes & Findings for A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain (NCT NCT05838742)

NCT ID: NCT05838742

Last Updated: 2025-11-10

Results Overview

Change from Baseline in knee pain due to Osteoarthritis were reported by weekly average of average daily pain numeric rating scale (NRS) at Week 12. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average daily knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the weekly average of average daily pain score was calculated using the mean value of available daily pain scores falling in the assessment window for each week. A negative change from baseline indicates an improvement in pain. Participants were asked to complete the pain NRS questionnaire at the same time in the evening each day. Baseline scores were assigned based on an average of 7 days prior to day 1 dosing visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with 95% confidence interval refers to 95% credible interval.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 314 participants
• Primary outcome timeframe: Baseline (Day -7 to Day -1) and at Week 12
• Results posted on: 2025-11-10

Participant Flow

A total of 314 participants were enrolled in the study. Out of which 310 participants were included in the full analysis set (FAS) population.

Of 314 participants enrolled, 4 participants were randomized but did not receive study dose, hence were excluded from the FAS.

Participant milestones

Measure	Placebo Participants received placebo subcutaneous (SC) injection once per week for 16 weeks.	GSK3858279 - 60 mg Weekly Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Overall Study STARTED	107	51	51	52	53
Overall Study Full Analysis Population	105	50	51	51	53
Overall Study COMPLETED	26	12	13	15	15
Overall Study NOT COMPLETED	81	39	38	37	38

Reasons for withdrawal

Measure	Placebo Participants received placebo subcutaneous (SC) injection once per week for 16 weeks.	GSK3858279 - 60 mg Weekly Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Overall Study Adverse Event	2	0	1	0	1
Overall Study Lost to Follow-up	1	1	1	0	0
Overall Study Physician Decision	0	0	0	0	1
Overall Study Withdrawal by Subject	8	3	3	1	4
Overall Study STUDY TERMINATED BY SPONSOR	68	34	33	34	32
Overall Study Lack of Efficacy	0	0	0	1	0
Overall Study Randomized, not treated	2	1	0	1	0

Baseline Characteristics

A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain

Baseline characteristics by cohort

Measure	Placebo n=105 Participants Participants received placebo SC injection once per week for 16 weeks.	GSK3858279 - 60 mg Weekly n=50 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=51 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=51 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=53 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	Total n=310 Participants Total of all reporting groups
Age, Continuous	63.7 YEARS STANDARD_DEVIATION 7.93 • n=5 Participants	65.6 YEARS STANDARD_DEVIATION 9.11 • n=20 Participants	63.6 YEARS STANDARD_DEVIATION 8.84 • n=40 Participants	64.0 YEARS STANDARD_DEVIATION 8.99 • n=28 Participants	64.5 YEARS STANDARD_DEVIATION 8.14 • n=46 Participants	64.2 YEARS STANDARD_DEVIATION 8.47 • n=34 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	35 Participants n=20 Participants	39 Participants n=40 Participants	33 Participants n=28 Participants	40 Participants n=46 Participants	211 Participants n=34 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	15 Participants n=20 Participants	12 Participants n=40 Participants	18 Participants n=28 Participants	13 Participants n=46 Participants	99 Participants n=34 Participants
Race/Ethnicity, Customized WHITE	81 Participants n=5 Participants	37 Participants n=20 Participants	39 Participants n=40 Participants	39 Participants n=28 Participants	33 Participants n=46 Participants	229 Participants n=34 Participants
Race/Ethnicity, Customized Asian	18 Participants n=5 Participants	7 Participants n=20 Participants	7 Participants n=40 Participants	7 Participants n=28 Participants	11 Participants n=46 Participants	50 Participants n=34 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	5 Participants n=20 Participants	3 Participants n=40 Participants	3 Participants n=28 Participants	8 Participants n=46 Participants	24 Participants n=34 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	1 Participants n=28 Participants	1 Participants n=46 Participants	3 Participants n=34 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=28 Participants	0 Participants n=46 Participants	3 Participants n=34 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=28 Participants	0 Participants n=46 Participants	1 Participants n=34 Participants

PRIMARY outcome

Timeframe: Baseline (Day -7 to Day -1) and at Week 12

Population: The analysis was performed on the full analysis set (FAS) that included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field.

Change from Baseline in knee pain due to Osteoarthritis were reported by weekly average of average daily pain numeric rating scale (NRS) at Week 12. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average daily knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the weekly average of average daily pain score was calculated using the mean value of available daily pain scores falling in the assessment window for each week. A negative change from baseline indicates an improvement in pain. Participants were asked to complete the pain NRS questionnaire at the same time in the evening each day. Baseline scores were assigned based on an average of 7 days prior to day 1 dosing visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with 95% confidence interval refers to 95% credible interval.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=60 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=30 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=29 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=31 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=31 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Change From Baseline in Weekly Average of Average Daily Knee Pain Intensity Using Numeric Rating Scale at Week 12	-2.13 Scores on Scale Interval -2.55 to -1.73	-1.66 Scores on Scale Interval -2.24 to -1.1	-1.88 Scores on Scale Interval -2.46 to -1.31	-1.74 Scores on Scale Interval -2.32 to -1.17	-2.03 Scores on Scale Interval -2.6 to -1.47

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 12

Population: The analysis was performed on FAS population which included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field.

The WOMAC pain subscale have a recall period of 48 hours and includes 5 subscales of pain assessment: 1-walking on flat, 2-going up downstairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. The total WOMAC pain subscale score ranges from 0-10; where 0 is no pain and 10 is extreme pain. The WOMAC pain subscale score was calculated by taking average of the 5 pain subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from baseline indicates an improvement in pain. Baseline WOMAC scores for each participant were assigned based on the score measured prior to first dosing on Day1 visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean change from baseline with a 95% confidence interval refers to 95% Credible Interval.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=59 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=29 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=27 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=32 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=32 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score At Week 12	-2.16 Scores on Scale Interval -2.59 to -1.74	-2.13 Scores on Scale Interval -2.73 to -1.52	-2.21 Scores on Scale Interval -2.82 to -1.59	-1.95 Scores on Scale Interval -2.54 to -1.36	-1.93 Scores on Scale Interval -2.52 to -1.36

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 12

Population: The analysis was performed on FAS population which included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field.

The WOMAC function subscale have a recall period of 48 hours and include 17 items of daily function assessments. The total WOMAC physical function subscale score ranges from 0-10 scale; where 0 is no difficulty and 10 is extremely difficult. The WOMAC physical function subscale score was calculated by taking the average of the 17 physical function subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC function subscale score minus the mean baseline WOMAC function subscale score. Baseline scores for each participant were assigned based on the score measured prior to first dosing on Day1 visit. A negative change from baseline indicated improvement. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean change from baseline with a 95% confidence interval refers to 95% Credible Interval.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=59 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=29 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=27 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=32 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=32 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Change From Baseline in WOMAC Physical Function Subscale Score at Week 12	-1.94 Scores on Scale Interval -2.36 to -1.53	-1.99 Scores on Scale Interval -2.58 to -1.4	-1.56 Scores on Scale Interval -2.15 to -0.97	-1.65 Scores on Scale Interval -2.23 to -1.08	-1.65 Scores on Scale Interval -2.22 to -1.11

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 12

Population: The analysis was performed on FAS population which included all randomized participants who received at least one dose of study intervention. Only those participants who had a measured outcome used in estimation or imputed outcome based on composite intercurrent event strategy at the current time point were included in the overall number of participants analyzed field.

The PtGA is an assessment for disease conditions and intensity of knee osteoarthritis (OA) pain. Participants will respond on a Likert scale ranging from 1-5 based on the question "Considering all the ways in which your knee OA affects you, how do you feel your knee OA is doing today?" and to identify a number from 1 = very good (asymptomatic and no limitation to normal activities) to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicate worse conditions. Baseline scores for each participant were assigned based on the scores reported prior to first dosing on Day 1 visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with a 95% confidence interval refers to 95% Credible Interval.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=58 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=28 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=27 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=32 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=32 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Change From Baseline in Patient Global Assessment Of Disease (PtGA) at Week 12	-0.55 Scores on Scale Interval -0.74 to -0.38	-0.57 Scores on Scale Interval -0.83 to -0.31	-0.55 Scores on Scale Interval -0.82 to -0.29	-0.55 Scores on Scale Interval -0.79 to -0.31	-0.55 Scores on Scale Interval -0.79 to -0.31

SECONDARY outcome

Timeframe: Up to 31 weeks

Population: The analysis was performed on safety population which included all participants who received at least 1 dose of study treatment.

AEs, SAEs, and AESIs were collected. An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAEs. The AESIs of the study drug included serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Injection site reactions.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=105 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=50 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=51 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=51 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=53 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESI) AEs	69 Participants	29 Participants	32 Participants	32 Participants	34 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESI) SAEs	4 Participants	3 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESI) AESIs	14 Participants	3 Participants	4 Participants	2 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 31 weeks

Population: The analysis was performed on safety population which included all participants who received at least 1 dose of study treatment. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure.

The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Worst case grade (G) increase from baseline grade was provided for all the laboratory tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0). Data for any participants with the worst-case grade changes (Increase or equal to Grade 3 or Increase to Grade 4) post-baseline are reported. Missing baseline grade was assumed as grade 0.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=99 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=48 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=48 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=47 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=49 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) AST, Increase to Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) Creatine Kinase, Worsening to Grade 3	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) Creatine Kinase, Worsening to Grade 4	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) Gamma Glutamyl Transferase, Worsening to Grade 3	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) Gamma Glutamyl Transferase, Worsening to Grade 4	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Greater Than or Equal to (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) Lymphocyte count decreased, worsening to Grade 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12

Population: The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed.

Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3858279 . Pharmacokinetic analysis was conducted using a model based analysis using all available data.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=26 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=23 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=25 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=25 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Maximum Concentration (Cmax) of GSK3858279	4603.1 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 48	12330.0 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 47	15383.5 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 51	22169.0 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 40	—

SECONDARY outcome

Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12

Population: The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed.

Tmax predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=26 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=23 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=25 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=25 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Time to Maximum Plasma Concentration (Tmax) of GSK3858279	1.454 Day Interval 0.78 to 2.04	1.751 Day Interval 0.94 to 3.9	1.412 Day Interval 0.88 to 2.26	1.377 Day Interval 0.73 to 2.26	—

SECONDARY outcome

Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12

Population: The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed.

Ctau predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=26 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=23 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=25 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=25 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Pre-Dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK3858279	2449.9 ng/mL Geometric Coefficient of Variation 63	3076.6 ng/mL Geometric Coefficient of Variation 59	7224.0 ng/mL Geometric Coefficient of Variation 60	11037.5 ng/mL Geometric Coefficient of Variation 52	—

SECONDARY outcome

Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12

Population: The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed.

Cavg predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=26 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=23 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=25 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=25 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Average Concentration Over a Dosing Interval (Cavg) of GSK3858279	3623.3 ng/mL Geometric Coefficient of Variation 51	7176.4 ng/mL Geometric Coefficient of Variation 48	11760.8 ng/mL Geometric Coefficient of Variation 53	16997.6 ng/mL Geometric Coefficient of Variation 42	—

SECONDARY outcome

Timeframe: Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12

Population: The analysis was performed on PK set which included all randomized participants in the Safety Population who had at least 1 dose of GSK3858279 and at least 1 non-missing PK assessment (Non-quantifiable values were considered as non-missing values). Only those participants with data available at specified time points have been analyzed.

AUC(0-tau) predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.

Outcome measures

Measure	GSK3858279 - 60 mg Weekly n=26 Participants Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=23 Participants Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=25 Participants Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=25 Participants Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-Tau) (AUC[0-Tau]) of GSK3858279	25362.8 day*ng/mL Geometric Coefficient of Variation 51	100469.4 day*ng/mL Geometric Coefficient of Variation 48	82325.8 day*ng/mL Geometric Coefficient of Variation 53	118983.5 day*ng/mL Geometric Coefficient of Variation 42	—

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 37 other events

Deaths: 0 deaths

GSK3858279 - 60 mg Weekly

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

GSK3858279 - 240 mg Every 2 Weeks

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

GSK3858279 - 240 mg Weekly

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

GSK3858279 - 360 mg Weekly

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=105 participants at risk Participants received placebo SC injection once per week for 16 weeks.	GSK3858279 - 60 mg Weekly n=50 participants at risk Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=51 participants at risk Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=51 participants at risk Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=53 participants at risk Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Cardiac disorders Acute coronary syndrome	0.00% 0/105 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	1.9% 1/53 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Cardiac disorders Angina pectoris	0.00% 0/105 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/105 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/50 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Herpes zoster	0.00% 0/105 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/50 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Tubo-ovarian abscess	0.95% 1/105 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Wound infection	0.95% 1/105 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/105 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	1.9% 1/53 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Tibia fracture	0.95% 1/105 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders Lipoedema	0.00% 0/105 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/50 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Transient ischaemic attack	0.95% 1/105 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.

Other adverse events

Measure	Placebo n=105 participants at risk Participants received placebo SC injection once per week for 16 weeks.	GSK3858279 - 60 mg Weekly n=50 participants at risk Participants received GSK3858279 60 mg SC injection once per week for 16 weeks.	GSK3858279 - 240 mg Every 2 Weeks n=51 participants at risk Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.	GSK3858279 - 240 mg Weekly n=51 participants at risk Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.	GSK3858279 - 360 mg Weekly n=53 participants at risk Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.
Infections and infestations Nasopharyngitis	7.6% 8/105 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	4.0% 2/50 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	7.8% 4/51 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	7.8% 4/51 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.7% 3/53 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 5/105 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	6.0% 3/50 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.9% 3/51 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	3.9% 2/51 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.7% 3/53 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	9.5% 10/105 • Number of events 28 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	16.0% 8/50 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	19.6% 10/51 • Number of events 20 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	11.8% 6/51 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	9.4% 5/53 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	1.9% 2/105 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	6.0% 3/50 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.9% 3/51 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	11.3% 6/53 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations COVID-19	2.9% 3/105 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	4.0% 2/50 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.9% 3/51 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	3.8% 2/53 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Infections and infestations Urinary tract infection	1.9% 2/105 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	6.0% 3/50 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	3.9% 2/51 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	3.8% 2/53 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.7% 6/105 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	4.0% 2/50 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	3.9% 2/51 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.7% 3/53 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
General disorders Injection site reaction	1.9% 2/105 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/50 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.9% 3/51 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.7% 3/53 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
General disorders Injection site bruising	3.8% 4/105 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.7% 3/53 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
General disorders Fatigue	0.95% 1/105 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	6.0% 3/50 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/51 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	1.9% 1/53 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	2.9% 3/105 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	2.0% 1/50 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.9% 3/51 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.9% 3/51 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.7% 3/53 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.95% 1/105 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/50 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	3.9% 2/51 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	7.8% 4/51 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/53 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications Fall	1.9% 2/105 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	4.0% 2/50 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/51 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.	5.7% 3/53 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 31. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.

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