Trial Outcomes & Findings for A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee (NCT NCT04520607)

NCT ID: NCT04520607

Last Updated: 2026-03-24

Results Overview

Change from OA-11-study baseline in mJSW measured in millimeters as documented by radiograph (X-ray) of the target knee. JSW measurements were provided by a blinded, central imaging vendor using landmark-based, computer-assisted proprietary methodology.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

276 participants

Primary outcome timeframe

OA-11-study baseline; Visit 3E (Week 48)

Results posted on

2026-03-24

Participant Flow

Subjects who completed Study OA-11 were invited to participate in Study OA-07

Participant milestones

Participant milestones
Measure	Placebo Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
1st Injection-As Randomized STARTED	138	138
1st Injection-As Randomized COMPLETED	118	110
1st Injection-As Randomized NOT COMPLETED	20	28
2nd Injection-Lorecivivint (Open Label) STARTED	118	110
2nd Injection-Lorecivivint (Open Label) COMPLETED	99	85
2nd Injection-Lorecivivint (Open Label) NOT COMPLETED	19	25
3nd Injection-Lorecivivint (Open Label) STARTED	99	85
3nd Injection-Lorecivivint (Open Label) COMPLETED	97	82
3nd Injection-Lorecivivint (Open Label) NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
1st Injection-As Randomized Adverse Event	1	0
1st Injection-As Randomized Lack of Efficacy	0	1
1st Injection-As Randomized Lost to Follow-up	3	4
1st Injection-As Randomized Withdrawal by Subject	6	11
1st Injection-As Randomized Physician Decision	0	1
1st Injection-As Randomized Not Otherwise Specified	9	9
1st Injection-As Randomized Total or Partial Knee Replacement	0	2
1st Injection-As Randomized Study Terminated by Sponsor	1	0
2nd Injection-Lorecivivint (Open Label) Lack of Efficacy	3	2
2nd Injection-Lorecivivint (Open Label) Adverse Event	0	1
2nd Injection-Lorecivivint (Open Label) Lost to Follow-up	5	5
2nd Injection-Lorecivivint (Open Label) Physician Decision	1	1
2nd Injection-Lorecivivint (Open Label) Withdrawal by Subject	6	11
2nd Injection-Lorecivivint (Open Label) Study Terminated by Sponsor	3	3
2nd Injection-Lorecivivint (Open Label) Not Otherwise Specified	1	2
3nd Injection-Lorecivivint (Open Label) Lost to Follow-up	1	1
3nd Injection-Lorecivivint (Open Label) Adverse Event	0	1
3nd Injection-Lorecivivint (Open Label) Total or Partial Knee Replacement	0	1
3nd Injection-Lorecivivint (Open Label) Site Terminated by Sponsor	1	0

Baseline Characteristics

A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=138 Participants Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=138 Participants Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Total n=276 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 8.6 • n=138 Participants	60.5 years STANDARD_DEVIATION 7.7 • n=62 Participants	61.0 years STANDARD_DEVIATION 8.2 • n=123 Participants
Sex: Female, Male Female	83 Participants n=138 Participants	90 Participants n=62 Participants	173 Participants n=123 Participants
Sex: Female, Male Male	55 Participants n=138 Participants	48 Participants n=62 Participants	103 Participants n=123 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=138 Participants	22 Participants n=62 Participants	52 Participants n=123 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=138 Participants	116 Participants n=62 Participants	224 Participants n=123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=138 Participants	0 Participants n=62 Participants	1 Participants n=123 Participants
Race (NIH/OMB) Asian	2 Participants n=138 Participants	1 Participants n=62 Participants	3 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=138 Participants	1 Participants n=62 Participants	1 Participants n=123 Participants
Race (NIH/OMB) Black or African American	35 Participants n=138 Participants	36 Participants n=62 Participants	71 Participants n=123 Participants
Race (NIH/OMB) White	96 Participants n=138 Participants	100 Participants n=62 Participants	196 Participants n=123 Participants
Race (NIH/OMB) More than one race	4 Participants n=138 Participants	0 Participants n=62 Participants	4 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Region of Enrollment United States	138 participants n=138 Participants	138 participants n=62 Participants	276 participants n=123 Participants
Kellgren-Lawrence Grade Grade 2	77 Participants n=138 Participants	74 Participants n=62 Participants	151 Participants n=123 Participants
Kellgren-Lawrence Grade Grade 3	61 Participants n=138 Participants	64 Participants n=62 Participants	125 Participants n=123 Participants
Body Mass Index	31.79 kg/m^2 STANDARD_DEVIATION 4.80 • n=138 Participants	31.87 kg/m^2 STANDARD_DEVIATION 4.93 • n=62 Participants	31.83 kg/m^2 STANDARD_DEVIATION 4.85 • n=123 Participants

PRIMARY outcome

Timeframe: OA-11-study baseline; Visit 3E (Week 48)

Population: The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in mJSW was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data.

Outcome measures

Outcome measures
Measure	Placebo n=120 Participants Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=109 Participants Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee	-0.2 mm Standard Error 0.05	-0.11 mm Standard Error 0.05

PRIMARY outcome

Timeframe: OA-07-study baseline; Visit 2E (Week 24)

Population: The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in WOMAC Pain was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data.

Change from OA-07-study baseline OA pain the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore ranges from 0 \[no pain\] to 100 \[pain as bad as it can be\].

Outcome measures

Outcome measures
Measure	Placebo n=131 Participants Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=129 Participants Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Change From OA-07-study Baseline OA Pain in the Target Knee	-1.96 score on a scale Standard Error 1.57	-6.48 score on a scale Standard Error 1.58

PRIMARY outcome

Timeframe: OA-07-study baseline; Visit 2E (Week 24)

Population: The Full Analysis Set includes all subjects who received a study injection in the current study, analyzed as randomized in the parent study. Change in WOMAC Function was calculated if both baseline and observation at timepoint were observed. No imputation methods were used for missing data.

Change from OA-07-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 \[highest functional status\] to 100 \[most impaired functional status\].

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=129 Participants Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Change From OA-07-study Baseline OA Function in the Target Knee	-2.84 score on a scale Standard Error 1.55	-6.52 score on a scale Standard Error 1.56

SECONDARY outcome

Timeframe: OA-07-study baseline; Visit 3E (Week 48)

Outcome measures

Outcome measures
Measure	Placebo n=123 Participants Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=119 Participants Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Change From OA-07-study Baseline OA Pain in the Target Knee	0.60 score on a scale Standard Error 1.66	-4.59 score on a scale Standard Error 1.69

SECONDARY outcome

Timeframe: OA-07-study baseline; Visit 3E (Week 48)

Outcome measures

Outcome measures
Measure	Placebo n=121 Participants Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=119 Participants Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Change From OA-07-study Baseline OA Function in the Target Knee	-0.17 score on a scale Standard Error 1.61	-5.02 score on a scale Standard Error 1.62

OTHER_PRE_SPECIFIED outcome

Timeframe: OA-11-study baseline; Visit 6E (Week 100)

Population: All subjects randomized to Lorecivivint are analyzed. Change in mJSW was calculated if both baseline and observation at Visit 6E (Week 100) were observed. No imputation methods were used for missing data. Open-label analysis without concurrent placebo comparison available. The baseline-adjusted ANCOVA estimate of change in mJSW at Visit 3E (Week 48) from the Placebo group was used to compare against the observed change in the Lorecivivint group at Visit 6E (Week 100).

Outcome measures

Outcome measures
Measure	Placebo n=78 Participants Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Change From OA-11-study Baseline Medial Joint Space Width (mJSW) in the Target Knee	-0.04 mm Standard Error 0.07	—

Adverse Events

Placebo-Lorecivivint

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Lorecivivint-Lorecivivint

Serious events: 4 serious events

Other events: 19 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Lorecivivint

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo-Lorecivivint n=118 participants at risk Subjects assigned to Placebo and continuing into the open-label portion of the study received one intra-articular injection of 0.7 mg lorecivivint in 2 ml vehicle into their target knee (the same target knee injected at Day 1) at Visit 3E (Week 48). Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint-Lorecivivint n=110 participants at risk Subjects assigned to Lorecivivint and continuing into the open-label portion of the study received one intra-articular injection of 0.7 mg lorecivivint in 2 ml vehicle into their target knee (the same target knee injected at Day 1) at Visit 3E (Week 48). Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Placebo n=138 participants at risk Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=138 participants at risk Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.72% 1/138 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Infections and infestations Gallbladder abscess	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.72% 1/138 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Vascular disorders Deep vein thrombosis	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.72% 1/138 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Infections and infestations Pneumonia	0.85% 1/118 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.72% 1/138 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.85% 1/118 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Cardiac disorders Acute myocardial infarction	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.91% 1/110 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.91% 1/110 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Cancer	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.91% 1/110 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.91% 1/110 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).

Other adverse events

Other adverse events
Measure	Placebo-Lorecivivint n=118 participants at risk Subjects assigned to Placebo and continuing into the open-label portion of the study received one intra-articular injection of 0.7 mg lorecivivint in 2 ml vehicle into their target knee (the same target knee injected at Day 1) at Visit 3E (Week 48). Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint-Lorecivivint n=110 participants at risk Subjects assigned to Lorecivivint and continuing into the open-label portion of the study received one intra-articular injection of 0.7 mg lorecivivint in 2 ml vehicle into their target knee (the same target knee injected at Day 1) at Visit 3E (Week 48). Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Placebo n=138 participants at risk Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1. Placebo: Healthcare professional-administered intra-articular injection of vehicle. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.	Lorecivivint n=138 participants at risk Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1. Lorecivivint: Healthcare professional-administered intra-articular injections of lorecivivint.
Infections and infestations COVID-19	2.5% 3/118 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	6.4% 7/110 • Number of events 7 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	5.1% 7/138 • Number of events 7 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Musculoskeletal and connective tissue disorders Arthralgia	0.85% 1/118 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	1.8% 2/110 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.9% 4/138 • Number of events 5 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	3.6% 5/138 • Number of events 5 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Infections and infestations Urinary tract infection	0.85% 1/118 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	3.6% 4/110 • Number of events 4 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Vascular disorders Hypertension	2.5% 3/118 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.7% 3/110 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	1.4% 2/138 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Blood and lymphatic system disorders Anaemia	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	1.4% 2/138 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/138 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/118 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.72% 1/138 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.85% 1/118 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.91% 1/110 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 4 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	1.4% 2/138 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Investigations Urine analysis abnormal	0.85% 1/118 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.00% 0/110 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.2% 3/138 • Number of events 4 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	0.72% 1/138 • Number of events 1 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).
Musculoskeletal and connective tissue disorders Back pain	1.7% 2/118 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	2.7% 3/110 • Number of events 3 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	1.4% 2/138 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).	1.4% 2/138 • Number of events 2 • Adverse events reported from the placebo-controlled, first year of OA-07 prior to open-label crossover to Lorecivivint from Baseline to Visit 3E (Week 48) by treatment group. If the subject participated in the open-label portion of the study, adverse events are reported from Visit 3E (Week 48) to Visit 6E (Week 100) by exposure group (i.e LOR-LOR vs PBO-LOR).

Additional Information

Christopher Swearingen, VP Biometrics

Biosplice Therapeutics, Inc

Phone: 858-926-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER