NCT02706886 is a Phase 1, PHASE2 clinical trial of Lumasiran in Primary Hyperoxaluria Type 1 (PH1), sponsored by Alnylam Pharmaceuticals.

Who is sponsoring NCT02706886?

NCT02706886 is sponsored by Alnylam Pharmaceuticals.

What drugs are being tested in NCT02706886?

Interventions in NCT02706886: Lumasiran, Placebo.

What condition does NCT02706886 study?

NCT02706886 studies Primary Hyperoxaluria Type 1 (PH1).

Is NCT02706886 still recruiting?

NCT02706886 is currently completed. Last updated 30 January 2020.

Are results published for NCT02706886?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-01-30 · How we verify

NCT02706886

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1

Completed Phase 1, PHASE2 Results posted Last updated 30 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Lumasiran in Primary Hyperoxaluria Type 1 (PH1) in 52 participants. Completed in 23 January 2019.

Timeline

8 March 2016

Primary endpoint
23 January 2019

23 January 2019

Quick facts

Lead sponsor	Alnylam Pharmaceuticals
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	52
Start date	8 March 2016
Primary completion	23 January 2019
Estimated completion	23 January 2019
Sites	9 locations across France, Netherlands, United Kingdom, Israel, Germany

Drugs / interventions tested

Lumasiran (LUMASIRAN) — full drug profile →
Placebo

Conditions studied

Primary Hyperoxaluria Type 1 (PH1) — all drugs for Primary Hyperoxaluria Type 1 (PH1) →

Sponsor

Alnylam Pharmaceuticals — full company profile →

Who can join

Adults 6 to 64, any sex, with Primary Hyperoxaluria Type 1 (PH1). 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.

Number of Participants With Adverse Events (AEs) Primary · Part A (SAD): Up to 405 days; Part B (MAD): Up to 546 days

An AE is any untoward medical occurrence in a clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Group	Value	95% CI
Part A: SAD: Placebo	5
Part A: SAD: Lumasiran 0.3 mg/kg	6
Part A: SAD: Lumasiran 1.0 mg/kg	2
Part A: SAD: Lumasiran 3.0 mg/kg	6
Part A: SAD: Lumasiran 6.0 mg/kg	6
Part B: MAD: Placebo	2
Part B: MAD: Lumasiran 1.0 mg/kg qM	8
Part B: MAD: Lumasiran 3.0 mg/kg qM	7
Part B: MAD: Lumasiran 3.0 mg/kg q3M	4

Maximum Concentration (Cmax) of Lumasiran in Plasma Secondary · Part A (SAD): Day 1: predose, 30 minutes (min), 1 hour (h), 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h

Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.

Day 1

Group	Value	95% CI
Part A: SAD: Lumasiran 0.3 mg/kg	39.7940	± 8.58882
Part A: SAD: Lumasiran 1.0 mg/kg	204.3748	± 111.68091
Part A: SAD: Lumasiran 3.0 mg/kg	533.4527	± 160.11060
Part A: SAD: Lumasiran 6.0 mg/kg	1176.1302	± 199.89797
Part B: MAD: Lumasiran 1.0 mg/kg qM	324.1386	± 489.71104
Part B: MAD: Lumasiran 3.0 mg/kg qM	582.4515	± 266.90105
Part B: MAD: Lumasiran 3.0 mg/kg q3M	432.2798	± 245.02660

Day 57

Group	Value	95% CI
Part B: MAD: Lumasiran 1.0 mg/kg qM	147.6780	± 67.97968
Part B: MAD: Lumasiran 3.0 mg/kg qM	701.1708	± 511.63001

Day 85

Group	Value	95% CI
Part B: MAD: Lumasiran 3.0 mg/kg q3M	411.5613	± 174.92146

Time to Cmax (Tmax) of Lumasiran in Plasma Secondary · Part A (SAD): Day 1: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h

Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.

Day 1

Group	Value	95% CI
Part A: SAD: Lumasiran 0.3 mg/kg	5.0167	4.000 – 8.017
Part A: SAD: Lumasiran 1.0 mg/kg	1.5000	0.517 – 8.000
Part A: SAD: Lumasiran 3.0 mg/kg	3.0000	0.500 – 8.000
Part A: SAD: Lumasiran 6.0 mg/kg	7.0000	0.500 – 8.067
Part B: MAD: Lumasiran 1.0 mg/kg qM	3.9917	0.567 – 5.967
Part B: MAD: Lumasiran 3.0 mg/kg qM	4.9917	0.533 – 12.000
Part B: MAD: Lumasiran 3.0 mg/kg q3M	9.0000	5.783 – 12.017

Day 57

Group	Value	95% CI
Part B: MAD: Lumasiran 1.0 mg/kg qM	3.0417	0.500 – 6.000
Part B: MAD: Lumasiran 3.0 mg/kg qM	2.9833	0.500 – 8.000

Day 85

Group	Value	95% CI
Part B: MAD: Lumasiran 3.0 mg/kg q3M	5.9833	4.050 – 7.950

Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of Lumasiran in Plasma Secondary · Part A (SAD): Day 1: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h

Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.

Day 1

Group	Value	95% CI
Part A: SAD: Lumasiran 0.3 mg/kg	293.5232	± 96.86989
Part A: SAD: Lumasiran 1.0 mg/kg	1899.8119	± 558.25326
Part A: SAD: Lumasiran 3.0 mg/kg	7211.5890	± 1125.64173
Part A: SAD: Lumasiran 6.0 mg/kg	16778.0579	± 4380.15325
Part B: MAD: Lumasiran 1.0 mg/kg qM	1428.0412	± 697.85233
Part B: MAD: Lumasiran 3.0 mg/kg qM	7400.2181	± 2331.89843
Part B: MAD: Lumasiran 3.0 mg/kg q3M	6337.9082	± 3840.03340

Day 57

Group	Value	95% CI
Part B: MAD: Lumasiran 1.0 mg/kg qM	1608.1457	± 708.95156
Part B: MAD: Lumasiran 3.0 mg/kg qM	7959.7873	± 1726.57675

Day 85

Group	Value	95% CI
Part B: MAD: Lumasiran 3.0 mg/kg q3M	5136.3462	± 2757.90139

Terminal Half-life (t1/2) of Lumasiran in Plasma Secondary · Part A (SAD): Day 1: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h

Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.

Day 1

Group	Value	95% CI
Part A: SAD: Lumasiran 1.0 mg/kg	7.0655	± 0.37379
Part A: SAD: Lumasiran 3.0 mg/kg	5.9798	± 1.52471
Part A: SAD: Lumasiran 6.0 mg/kg	3.4683	± NA
Part B: MAD: Lumasiran 1.0 mg/kg qM	3.2670	± 1.52759
Part B: MAD: Lumasiran 3.0 mg/kg qM	5.4574	± 3.49432
Part B: MAD: Lumasiran 3.0 mg/kg q3M	7.8028	± NA

Day 57

Group	Value	95% CI
Part B: MAD: Lumasiran 1.0 mg/kg qM	7.8090	± 4.52009
Part B: MAD: Lumasiran 3.0 mg/kg qM	5.8356	± 3.12156

Day 85

Group	Value	95% CI
Part B: MAD: Lumasiran 3.0 mg/kg q3M	4.6694	± NA

Fraction Excreted in Urine in 24 Hours (Fe0-24) of Lumasiran Secondary · Part A (SAD): Day 1: pooled urine 0-4 h, 4-8 h and 8-24 h; Part B (MAD): Part B (MAD phase): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: pooled urine 0-4 h, 4-8 h, 8-12 h and 12-24 h

Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.

Day 1

Group	Value	95% CI
Part A: SAD: Lumasiran 0.3 mg/kg	17.4219	± 2.44129
Part A: SAD: Lumasiran 1.0 mg/kg	19.0713	± 3.88914
Part A: SAD: Lumasiran 3.0 mg/kg	21.0472	± 5.36667
Part A: SAD: Lumasiran 6.0 mg/kg	25.7931	± 3.25937
Part B: MAD: Lumasiran 1.0 mg/kg qM	11.0895	± 3.74207
Part B: MAD: Lumasiran 3.0 mg/kg qM	11.1877	± 6.07719
Part B: MAD: Lumasiran 3.0 mg/kg q3M	7.1691	± 2.37465

Day 57

Group	Value	95% CI
Part B: MAD: Lumasiran 1.0 mg/kg qM	9.4698	± 4.21949
Part B: MAD: Lumasiran 3.0 mg/kg qM	12.4604	± 4.02897

Day 85

Group	Value	95% CI
Part B: MAD: Lumasiran 3.0 mg/kg q3M	13.6938	± 3.60004

Renal Clearance (CLR) of Lumasiran Secondary · Part A (SAD): Day 1: pooled urine 0-4 h, 4-8 h and 8-24 h; Part B (MAD): Part B (MAD phase): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: pooled urine 0-4 h, 4-8 h, 8-12 h and 12-24 h

Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.

Day 1

Group	Value	95% CI
Part A: SAD: Lumasiran 0.3 mg/kg	8.7817	± NA
Part A: SAD: Lumasiran 1.0 mg/kg	5.4906	± 2.07402
Part A: SAD: Lumasiran 3.0 mg/kg	5.8211	± 1.31377
Part A: SAD: Lumasiran 6.0 mg/kg	6.3417	± 1.15497
Part B: MAD: Lumasiran 1.0 mg/kg qM	2.2612	± 1.17616
Part B: MAD: Lumasiran 3.0 mg/kg qM	2.3818	± 1.13067
Part B: MAD: Lumasiran 3.0 mg/kg q3M	2.0564	± 1.20600

Day 57

Group	Value	95% CI
Part B: MAD: Lumasiran 1.0 mg/kg qM	1.9610	± 1.11228
Part B: MAD: Lumasiran 3.0 mg/kg qM	2.5150	± 0.80386

Day 85

Group	Value	95% CI
Part B: MAD: Lumasiran 3.0 mg/kg q3M	3.3663	± 1.18371

Baseline Plasma Glycolate Concentration Secondary · Part A (SAD): Baseline, Part B (MAD): Baseline

The pharmacodynamic (PD) outcome measure of plasma glycolate concentration could only be calculated for Part A. Due to an issue with the plasma glycolate assay at the testing laboratory the data for Part B could not be calculated.

Group	Value	95% CI
Part A: SAD: Placebo	5.1	± 1.73
Part A: SAD: Lumasiran 0.3 mg/kg	5.3	± 1.51
Part A: SAD: Lumasiran 1.0 mg/kg	5.7	± 1.97
Part A: SAD: Lumasiran 3.0 mg/kg	6.2	± 2.56
Part A: SAD: Lumasiran 6.0 mg/kg	4.8	± 1.72

Percentage Change From Baseline in Plasma Glycolate Concentration Secondary · Part A (SAD): Days 15, 29, 57 and 85; Part B (MAD): Days 15, 29, 57, 85

The PD outcome measure of plasma glycolate concentration could only be calculated for Part A. Due to an issue with the plasma glycolate assay at the testing laboratory the data for Part B could not be calculated.

Day 15

Group	Value	95% CI
Part A: SAD: Placebo	18.3	± 67.19
Part A: SAD: Lumasiran 0.3 mg/kg	58.3	± 55.29
Part A: SAD: Lumasiran 1.0 mg/kg	48.5	± 82.99
Part A: SAD: Lumasiran 3.0 mg/kg	56.4	± 28.50
Part A: SAD: Lumasiran 6.0 mg/kg	59.5	± 49.00

Day 29

Group	Value	95% CI
Part A: SAD: Placebo	22.4	± 46.83
Part A: SAD: Lumasiran 0.3 mg/kg	32.9	± 57.67
Part A: SAD: Lumasiran 1.0 mg/kg	70.6	± 82.74
Part A: SAD: Lumasiran 3.0 mg/kg	146.4	± 81.99
Part A: SAD: Lumasiran 6.0 mg/kg	390.1	± 270.40

Day 57

Group	Value	95% CI
Part A: SAD: Placebo	126.7	± 242.68
Part A: SAD: Lumasiran 0.3 mg/kg	66.3	± 38.07
Part A: SAD: Lumasiran 1.0 mg/kg	109.8	± 124.29
Part A: SAD: Lumasiran 3.0 mg/kg	230.1	± 180.36
Part A: SAD: Lumasiran 6.0 mg/kg	730.4	± 439.54

Day 85

Group	Value	95% CI
Part A: SAD: Placebo	31.2	± 131.04
Part A: SAD: Lumasiran 0.3 mg/kg	15.6	± 100.54
Part A: SAD: Lumasiran 1.0 mg/kg	40.7	± 110.75
Part A: SAD: Lumasiran 3.0 mg/kg	196.2	± 152.41
Part A: SAD: Lumasiran 6.0 mg/kg	731.3	± 375.02

Baseline Spot Urine Glycolate:Creatinine Ratio in Part A Secondary · Part A (SAD): Baseline

The endpoint was only measured in Part A.

Group	Value	95% CI
Part A: SAD: Placebo	12.4	± 4.63
Part A: SAD: Lumasiran 0.3 mg/kg	15.7	± 4.27
Part A: SAD: Lumasiran 1.0 mg/kg	15.7	± 3.14
Part A: SAD: Lumasiran 3.0 mg/kg	13.0	± 3.52
Part A: SAD: Lumasiran 6.0 mg/kg	14.8	± 4.31

Percentage Change From Baseline in Spot Urine Glycolate:Creatinine Ratio in Part A Secondary · Part A (SAD): Days 29 and 57

The endpoint was only measured in Part A.

Day 29

Group	Value	95% CI
Part A: SAD: Placebo	8.1	± 43.42
Part A: SAD: Lumasiran 0.3 mg/kg	32.5	± 22.6
Part A: SAD: Lumasiran 1.0 mg/kg	82.9	± 65.00
Part A: SAD: Lumasiran 3.0 mg/kg	109.1	± 66.51
Part A: SAD: Lumasiran 6.0 mg/kg	210.5	± 199.30

Day 57

Group	Value	95% CI
Part A: SAD: Placebo	73.8	± 108.9
Part A: SAD: Lumasiran 0.3 mg/kg	38.0	± 50.62
Part A: SAD: Lumasiran 1.0 mg/kg	47.8	± 41.03
Part A: SAD: Lumasiran 3.0 mg/kg	215.0	± 178.72
Part A: SAD: Lumasiran 6.0 mg/kg	310.7	± 94.51

Baseline of 24 Hour Urine Oxalate Corrected for BSA in Part B Secondary · Part B (MAD): Baseline

The endpoint was only measured in Part B.

Group	Value	95% CI
Part B: MAD: Placebo	1.96	± 0.321
Part B: MAD: Lumasiran 1.0 mg/kg qM	1.73	± 0.696
Part B: MAD: Lumasiran 3.0 mg/kg qM	1.84	± 0.621
Part B: MAD: Lumasiran 3.0 mg/kg q3M	1.30	± 0.350

Adverse events — posted to ClinicalTrials.gov

Time frame: Part A (SAD phase): Up to 405 days; Part B (MAD phase): Up to 546 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: SAD: Placebo

Serious: 0/8 (0%)

Deaths: 0/8

Part A: SAD: Lumasiran 0.3 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Part A: SAD: Lumasiran 1.0 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Part A: SAD: Lumasiran 3.0 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Part A: SAD: Lumasiran 6.0 mg/kg

Serious: 0/6 (0%)

Deaths: 0/6

Part B: MAD: Placebo

Serious: 1/3 (33%)

Deaths: 0/3

Part B: MAD: Lumasiran 1.0 mg/kg qM

Serious: 1/8 (13%)

Deaths: 0/8

Part B: MAD: Lumasiran 3.0 mg/kg qM

Serious: 3/8 (38%)

Deaths: 0/8

Part B: MAD: Lumasiran 3.0 mg/kg q3M

Serious: 0/4 (0%)

Deaths: 0/4

Serious adverse events (6 terms)

Reaction	System	Part A: SAD: Placebo	Part A: SAD: Lumasiran 0.3…	Part A: SAD: Lumasiran 1.0…	Part A: SAD: Lumasiran 3.0…	Part A: SAD: Lumasiran 6.0…	Part B: MAD: Placebo	Part B: MAD: Lumasiran 1.0…	Part B: MAD: Lumasiran 3.0…	Part B: MAD: Lumasiran 3.0…
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—

Other adverse events (78 terms — click to expand)

Reaction	System	Part A: SAD: Placebo	Part A: SAD: Lumasiran 0.3…	Part A: SAD: Lumasiran 1.0…	Part A: SAD: Lumasiran 3.0…	Part A: SAD: Lumasiran 6.0…	Part B: MAD: Placebo	Part B: MAD: Lumasiran 1.0…	Part B: MAD: Lumasiran 3.0…	Part B: MAD: Lumasiran 3.0…
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Faeces soft	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—
Periodontitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Viral pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Head injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Tendon injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—	—	—
Alcoholic hangover	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Papule	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Rash follicular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Skin texture abnormal	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Caffeine consumption	Social circumstances	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Vomiting, Nephrolithiasis, Pyelonephritis acute, Abdominal pain, Pyrexia, Gastroenteritis.

Data from ClinicalTrials.gov NCT02706886 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (PH1). In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients that initially received placebo received lumasiran after completing placebo dosing.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic siRNA: state of the art.
Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x
Advances in the delivery of RNA therapeutics: from concept to clinical reality.
Kaczmarek JC, Kowalski PS, Anderson DG. · · 2017 · cited 467× · PMID 28655327 · DOI 10.1186/s13073-017-0450-0
The growth of siRNA-based therapeutics: Updated clinical studies.
Zhang MM, Bahal R, Rasmussen TP, Manautou JE, et al · · 2021 · cited 366× · PMID 33513339 · DOI 10.1016/j.bcp.2021.114432
Preclinical and Clinical Advances of GalNAc-Decorated Nucleic Acid Therapeutics.
Huang Y. · · 2017 · cited 205× · PMID 28325278 · DOI 10.1016/j.omtn.2016.12.003
RNAi-Based Therapeutics and Novel RNA Bioengineering Technologies.
Traber GM, Yu AM. · · 2023 · cited 184× · PMID 35680378 · DOI 10.1124/jpet.122.001234
Opportunities and challenges for antisense oligonucleotide therapies.
Kuijper EC, Bergsma AJ, Pijnappel WWMP, Aartsma-Rus A. · · 2021 · cited 107× · PMID 32391605 · DOI 10.1002/jimd.12251
Engineering functional inorganic-organic hybrid systems: advances in siRNA therapeutics.
Shen J, Zhang W, Qi R, Mao ZW, et al · · 2018 · cited 91× · PMID 29417968 · DOI 10.1039/c7cs00479f
Improved Nucleic Acid Therapy with Advanced Nanoscale Biotechnology.
Weng Y, Huang Q, Li C, Yang Y, et al · · 2020 · cited 72× · PMID 31927331 · DOI 10.1016/j.omtn.2019.12.004

Verify or expand the search:

Other trials of Lumasiran

Trials testing the same drug.

NCT06225544 — Lumasiran in Hyperoxalaemic Patients on Haemodialysis · Phase 2 · recruiting
NCT05161936 — A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate · Phase 2 · terminated
NCT04152200 — A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 · Phase 3 · completed
NCT03905694 — A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1 · Phase 3 · completed
NCT03681184 — A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 · Phase 3 · completed

Other recruiting trials for Primary Hyperoxaluria Type 1 (PH1)

Currently open trials in the same condition.

NCT04042402 — Long Term Extension Study in Patients With Primary Hyperoxaluria · Phase 3 · active not recruiting

Other Alnylam Pharmaceuticals trials

Trials by the same sponsor.

NCT07535606 — A Study to Evaluate ALN-4915 in Adult Healthy Volunteers · Phase 1 · recruiting
NCT07463846 — A Study to Evaluate ALN-2232 in Participants With Obesity · Phase 1, PHASE2 · recruiting
NCT07223203 — TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidos · Phase 3 · recruiting
NCT07465224 — A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus · Phase 2 · recruiting
NCT07358078 — DemonsTTRate: A Global, Observational, Multicenter, Long-term Study of Patients With ATTR-CM in a Real-World Setting · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02706886 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Alnylam Pharmaceuticals
Last refreshed: 30 January 2020

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/NCT02706886.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02706886

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Lumasiran

Other recruiting trials for Primary Hyperoxaluria Type 1 (PH1)

Other Alnylam Pharmaceuticals trials

Verify against primary sources