Adults 35 to 75, any sex, with Osteoarthritis (OA). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Cartilage Volume in the Index Region Measured by 7 Tesla MRIPrimary· Baseline, Week 28
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee. Change from baseline in cartilage volume was analyzed using the mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR).
Group
Value
95% CI
LRX712 15 mg
63.3
± 54.93
LRX712 25 mg
49.8
± 50.57
Placebo
11.6
± 45.54
Time to Reach the Maximum Plasma Concentration (Tmax) of LRX712Secondary· Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57
Tmax is the time to reach maximum (peak) LRX712 concentration after single-dose administration (time). LRX712 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 25 pg/mL.
Day 1
Group
Value
95% CI
LRX712 15 mg
17.5
12.0 – 24.0
LRX712 25 mg
23.3
0.50 – 24.1
LRX712 75 mg
24.0
12.0 – 24.1
Day 29
Group
Value
95% CI
LRX712 15 mg
23.8
22.6 – 24.0
LRX712 25 mg
24.0
22.2 – 24.2
LRX712 75 mg
23.9
23.8 – 24.0
Day 57
Group
Value
95% CI
LRX712 15 mg
24.0
21.9 – 24.0
LRX712 25 mg
24.0
22.0 – 24.1
LRX712 75 mg
24.0
23.5 – 24.0
Maximum Observed Plasma Concentration (Cmax) of LRX712Secondary· Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57
Cmax is defined as the maximum (peak) observed concentration following a dose. LRX712 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 25 pg/mL.
Day 1
Group
Value
95% CI
LRX712 15 mg
3.52
± 2.07
LRX712 25 mg
6.54
± 5.33
LRX712 75 mg
6.94
± 4.96
Day 29
Group
Value
95% CI
LRX712 15 mg
3.33
± 2.57
LRX712 25 mg
3.50
± 1.43
LRX712 75 mg
27.0
± 31.6
Day 57
Group
Value
95% CI
LRX712 15 mg
2.39
± 0.951
LRX712 25 mg
4.05
± 2.25
LRX712 75 mg
29.5
± 20.4
Minimum Observed Plasma Concentration (Cmin) of LRX712Secondary· Pre-dose on Day 29; Pre-dose, 1344 hours after dose on Day 57 (LRX712 15 mg arm) and 3360 hours after dose on Day 57 (LRX712 25 mg and 75 mg arms)
Cmin is defined as the minimum (peak) observed concentration following a dose. LRX712 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 25 pg/mL.
Dose 1 (pre-dose Day 29)
Group
Value
95% CI
LRX712 15 mg
0.0735
± 0.10
LRX712 25 mg
0.0823
± 0.115
LRX712 75 mg
0.231
± 0.401
Dose 2 (pre-dose Day 57)
Group
Value
95% CI
LRX712 15 mg
0.111
± 0.109
LRX712 25 mg
0.202
± 0.204
LRX712 75 mg
0.365
± 0.585
Dose 3 (post-dose Day 57)
Group
Value
95% CI
LRX712 15 mg
0.0439
± 0.0740
LRX712 25 mg
0.00379
± 0.0131
LRX712 75 mg
0.0120
± 0.0208
Synovial Fluid Concentrations of LRX712Secondary· Pre-dose on Day 1, 29 and 57
The observed synovial concentration following a dose. LRX712 concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 20 ng/mL. Samples were collected from a limited number of participants.
Day 1
Group
Value
95% CI
LRX712 15 mg
0
LRX712 25 mg
0
± 0
Day 29
Group
Value
95% CI
LRX712 15 mg
0
LRX712 25 mg
0
Day 57
Group
Value
95% CI
LRX712 25 mg
0
± 0
Time to Reach the Maximum Plasma Concentration (Tmax) of MAE344Secondary· Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57
Tmax is the time to reach maximum (peak) MAE344 concentration after single-dose administration (time). MAE344 is a metabolite of LRX712 and plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 100 pg/mL.
Day 1
Group
Value
95% CI
LRX712 15 mg
23.5
12.0 – 24.1
LRX712 25 mg
24.0
12.0 – 169
LRX712 75 mg
24.1
24.0 – 24.1
Day 29
Group
Value
95% CI
LRX712 15 mg
23.8
22.6 – 24.0
LRX712 25 mg
24.0
22.2 – 193
LRX712 75 mg
23.9
23.8 – 24.0
Day 57
Group
Value
95% CI
LRX712 15 mg
24.0
21.9 – 169
LRX712 25 mg
24.0
22.0 – 24.1
LRX712 75 mg
24.0
23.5 – 24.0
Maximum Observed Plasma Concentration (Cmax) of MAE344Secondary· Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57
Cmax is defined as the maximum (peak) observed concentration following a dose. MAE344 is a metabolite of LRX712 and plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 100 pg/mL.
Day 1
Group
Value
95% CI
LRX712 15 mg
38.3
± 23.0
LRX712 25 mg
52.1
± 47.3
LRX712 75 mg
75.2
± 63.1
Day 29
Group
Value
95% CI
LRX712 15 mg
42.6
± 37.4
LRX712 25 mg
40.5
± 24.6
LRX712 75 mg
281
± 329
Day 57
Group
Value
95% CI
LRX712 15 mg
26.0
± 11.8
LRX712 25 mg
45.1
± 33.7
LRX712 75 mg
321
± 170
Minimum Observed Plasma Concentration (Cmin) of MAE344Secondary· Pre-dose on Day 29; Pre-dose, 1344 hours after dose on Day 57 (LRX712 15 mg arm) and 3360 hours after dose on Day 57 (LRX712 25 mg and 75 mg arms)
Cmin is defined as the minimum (peak) observed concentration following a dose. MAE344 is a metabolite of LRX712 and plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 100 pg/mL.
Dose 1 (pre-dose Day 29)
Group
Value
95% CI
LRX712 15 mg
1.34
± 1.76
LRX712 25 mg
1.49
± 1.82
LRX712 75 mg
4.11
± 7.01
Dose 2 (pre-dose Day 57)
Group
Value
95% CI
LRX712 15 mg
2.12
± 2.15
LRX712 25 mg
3.04
± 3.06
LRX712 75 mg
5.70
± 9.10
Dose 3 (post-dose Day 57)
Group
Value
95% CI
LRX712 15 mg
0.916
± 1.22
LRX712 25 mg
0.0557
± 0.140
LRX712 75 mg
0.257
± 0.445
Synovial Fluid Concentrations of MAE344Secondary· Pre-dose on Day 1, 29 and 57
The observed synovial concentration following a dose. MAE344 is a metabolite of LRX712 and concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 80 ng/mL. Samples were collected from a limited number of participants.
Day 1
Group
Value
95% CI
LRX712 15 mg
0
LRX712 25 mg
0
± 0
Day 29
Group
Value
95% CI
LRX712 15 mg
0
LRX712 25 mg
0
Day 57
Group
Value
95% CI
LRX712 25 mg
0
± 0
Change From Baseline in Articular Cartilage [23Na] Content Measured by 7 Tesla MRISecondary· Baseline, Week 16, 28 and 52
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in articular cartilage quality (assessed by changes in glycosaminoglycans content measured by sodium content) in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee quality. Change from baseline in articular cartilage content was analyzed using a mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed
Week 16
Group
Value
95% CI
LRX712 15 mg
-7.4
± 12.00
LRX712 25 mg
12.7
± 11.99
Placebo
8.5
± 9.20
Week 28
Group
Value
95% CI
LRX712 15 mg
-15.5
± 11.21
LRX712 25 mg
8.9
± 11.13
Placebo
4.0
± 9.24
Week 52
Group
Value
95% CI
LRX712 15 mg
3.1
± 12.12
LRX712 25 mg
26.6
± 11.19
Placebo
5.5
± 9.20
Change From Baseline in Cartilage Volume in the Index Region Measured by 7 Tesla MRISecondary· Baseline, Week 16 and 52
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee quality. Change from baseline in cartilage volume was analyzed using a mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR)
Week 16
Group
Value
95% CI
LRX712 15 mg
-48.0
± 52.64
LRX712 25 mg
-17.4
± 50.09
Placebo
24.4
± 43.05
Week 52
Group
Value
95% CI
LRX712 15 mg
19.5
± 73.11
LRX712 25 mg
49.3
± 67.29
Placebo
123.1
± 60.62
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
LRX712 15 mg
Serious: 0/12 (0%)
Deaths: 0/12
LRX712 25 mg
Serious: 0/14 (0%)
Deaths: 0/14
LRX712 75 mg
Serious: 0/3 (0%)
Deaths: 0/3
LRX712 15mg and 25mg
Serious: 0/26 (0%)
Deaths: 0/26
Placebo
Serious: 0/16 (0%)
Deaths: 0/16
LRX712 15 mg_Post-treatment
Serious: 1/12 (8%)
Deaths: 0/12
LRX712 25 mg_Post-treatment
Serious: 1/14 (7%)
Deaths: 0/14
LRX712 75 mg_Post-treatment
Serious: 0/3 (0%)
Deaths: 0/3
LRX712 15mg and 25mg_Post-treatment
Serious: 2/26 (8%)
Deaths: 0/26
Placebo_Post-treatment
Serious: 1/16 (6%)
Deaths: 0/16
Total
Serious: 3/45 (7%)
Deaths: 0/45
Serious adverse events (3 terms)
Reaction
System
LRX712 15 mg
LRX712 25 mg
LRX712 75 mg
LRX712 15mg and 25mg
Placebo
LRX712 15 mg_Post-treatment
LRX712 25 mg_Post-treatment
LRX712 75 mg_Post-treatment
LRX712 15mg and 25mg_Post-…
Placebo_Post-treatment
Total
Myocardial infarction
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
Multiple fractures
Injury, poisoning and procedural complications
—
—
—
—
—
—
—
—
—
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study explored the preliminary efficacy of multiple intra-articular injections of LRX712 by evaluating the ability of the drug to restore structural integrity of articular cartilage. Efficacy was evaluated in the context of the systemic safety and local tolerability of the investigational drug.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03355196 — First-in-human, Safety, Tolerability and Pharmacokinetics Study of LRX712 in Osteoarthritic Patients
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 30 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04097379.