ClinicalTrials.gg
TerminatedNCT03225833PRECISION-HD1Updated Feb 10, 2022Results posted

Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

A Phase 1/2 interventional study of WVE-120101 and Placebo in Huntington's Disease, sponsored by Wave Life Sciences USA, Inc.. Terminated at 21 sites in 7 countries. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-10.

Sponsored by Wave Life Sciences USA, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Lack of Efficacy
Phase
Phase 1/2
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).

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Conditions studied

  • Huntington's Disease

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03

In context

Huntington Disease

290 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.

This study's enrollment of 61 is above the median of 40 across 206 interventional studies indexed under Huntington Disease.

Browse Huntington Disease studies →

Lead sponsor

Wave Life Sciences USA, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion
  • Ambulatory, male or female patients aged ≥25 - ≤65 years
  • Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
  • Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13

Key Exclusion Criteria:

  • Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years.
  • Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 half-lives of the oligonucleotide, whichever is longer
  • Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy
  • Inability to undergo brain MRI
  • Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    WVE-120101 (Dose A) or placebo

    Drug: WVE-120101 · Drug: Placebo

  • Experimental
    WVE-120101 (Dose B) or placebo

    Drug: WVE-120101 · Drug: Placebo

  • Experimental
    WVE-120101 (Dose C) or placebo

    Drug: WVE-120101 · Drug: Placebo

  • Experimental
    WVE-120101 (Dose D) or placebo

    Drug: WVE-120101 · Drug: Placebo

  • Experimental
    WVE-120101 (Dose E) or placebo

    Drug: WVE-120101 · Drug: Placebo

Interventions

  • DrugWVE-120101

    WVE-120101 is a stereopure antisense oligonucleotide (ASO)

  • DrugPlacebo

    0.9% Sodium Chloride

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What researchers measure

Primary outcomes

  1. Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)

    All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states

    Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])

  2. Safety: Severity of Adverse Events

    Number of patients who experienced a severe treatment-emergent adverse event. Severity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])

  3. Safety: Number of Patients With Serious TEAEs

    A serious TEAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect not present at Prescreening.

    Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])

  4. Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs

    Time frame: Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)

    Cmax of WVE-120101 in plasma

    Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.

  2. PK: Time of Occurrence of Cmax (Tmax)

    tmax of WVE-120101 in plasma

    Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.

  3. PK: Area Under the Plasma Concentration-time Curve (AUClast)

    AUClast from time 0 to the last quantifiable concentration of WVE-120101 in plasma

    Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.

  4. PK: Terminal Elimination Half Life

    Terminal elimination half life of WVE-120101 in plasma (t1/2)

    Time frame: Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.

  5. Pharmacodynamics

    Percentage change from baseline in concentration of mutant huntingtin (mHTT) protein in CSF

    Time frame: Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)

  6. Clinical Effects: Total Functional Capacity (TFC)

    Percentage change from baseline to the last measured time point in the Total Functional Capacity score, administered as part of the Unified Huntington's Disease Rating Scale (UHDRS). Total Functional Capacity is scored 13 (normal) to 0 (severe disability).

    Time frame: Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)

07

Results

Posted Feb 10, 2022

Participant flow

Participant flow — Overall Study
MilestonePooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Started16999810
Single dose period only112004
Multiple dose period only000001
Single dose and multiple dose periods1587985
Completed1187970
Not completed5120110
Withdrew: Adverse event012002
Withdrew: Withdrawal by subject100010
Withdrew: Termination of study by sponsor400007
Withdrew: Sponsor decision000001

Outcome measures

PrimarySafety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)

All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states

Time frame:
Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
Reported as:
Count of participants · Participants
Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)
ParticipantsPooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)1288979
PrimarySafety: Severity of Adverse Events

Number of patients who experienced a severe treatment-emergent adverse event. Severity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Time frame:
Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
Reported as:
Count of participants · Participants
Safety: Severity of Adverse Events
ParticipantsPooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Safety: Severity of Adverse Events121105
PrimarySafety: Number of Patients With Serious TEAEs

A serious TEAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect not present at Prescreening.

Time frame:
Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
Reported as:
Count of participants · Participants
Safety: Number of Patients With Serious TEAEs
ParticipantsPooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Safety: Number of Patients With Serious TEAEs021004
PrimarySafety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
Time frame:
Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])
Reported as:
Count of participants · Participants
Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
ParticipantsPooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs012002
SecondaryPharmacokinetics (PK): Maximum Observed Concentration (Cmax)

Cmax of WVE-120101 in plasma

Time frame:
Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Reported as:
Mean · ng/mL
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
ng/mLWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Day 17.70 ± 7.90123.54 ± 18.13932.82 ± 22.964184.48 ± 209.470229.01 ± 168.330
Day 11213.296 ± 6.05714.27 ± 12.574———
SecondaryPK: Time of Occurrence of Cmax (Tmax)

tmax of WVE-120101 in plasma

Time frame:
Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Reported as:
Mean · hours
PK: Time of Occurrence of Cmax (Tmax)
hoursWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Day 11.34 ± 1.1031.58 ± 1.0812.66 ± 1.3912.71 ± 3.0684.61 ± 7.054
Day 1121.99 ± 0.9342.23 ± 1.175———
SecondaryPK: Area Under the Plasma Concentration-time Curve (AUClast)

AUClast from time 0 to the last quantifiable concentration of WVE-120101 in plasma

Time frame:
Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Reported as:
Mean · hr*ng/mL
PK: Area Under the Plasma Concentration-time Curve (AUClast)
hr*ng/mLWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Day 135.20 ± 16.03790.77 ± 50.672255.14 ± 98.3421133.74 ± 551.9971968.31 ± 1188.173
Day 11236.19 ± 20.13549.54 ± 34.735———
SecondaryPK: Terminal Elimination Half Life

Terminal elimination half life of WVE-120101 in plasma (t1/2)

Time frame:
Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.
Reported as:
Median · hours
PK: Terminal Elimination Half Life
hoursWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
PK: Terminal Elimination Half Life——8.12 (7.1 to 40.0)12.30 (6.9 to 25.5)14.38 (5.5 to 46.9)
SecondaryPharmacodynamics

Percentage change from baseline in concentration of mutant huntingtin (mHTT) protein in CSF

Time frame:
Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)
Reported as:
Median · Percent change from baseline
Pharmacodynamics
Percent change from baselinePooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Pharmacodynamics-6.62 (-16.76 to 7.73)-5.20 (-10.94 to 0.15)-12.33 (-19.81 to 9.63)-8.58 (-11.92 to -1.79)-11.73 (-20.44 to 3.37)-9.13 (-37.51 to 15.29)
SecondaryClinical Effects: Total Functional Capacity (TFC)

Percentage change from baseline to the last measured time point in the Total Functional Capacity score, administered as part of the Unified Huntington's Disease Rating Scale (UHDRS). Total Functional Capacity is scored 13 (normal) to 0 (severe disability).

Time frame:
Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)
Reported as:
Median · % Change from Baseline
Clinical Effects: Total Functional Capacity (TFC)
% Change from BaselinePooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Clinical Effects: Total Functional Capacity (TFC)0.00 (-9.09 to 0.00)0.00 (-4.17 to 9.09)0.00 (-7.69 to 11.11)0.00 (-20.00 to 0.00)4.17 (-3.85 to 10.42)0.00 (0.00 to 0.00)

Adverse events

Collected over Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts]). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pooled Placebo0/16 (0%)0/16 (0%)12/16 (75%)
WVE-120101 (2 mg)0/9 (0%)2/9 (22.2%)8/9 (88.9%)
WVE-120101 (4 mg)0/9 (0%)1/9 (11.1%)8/9 (88.9%)
WVE-120101 (8 mg)0/9 (0%)0/9 (0%)9/9 (100%)
WVE-120101 (16 mg)0/8 (0%)0/8 (0%)7/8 (87.5%)
WVE-120101 (32 mg)0/10 (0%)4/10 (40%)9/10 (90%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventPooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
Skull FractureInjury, poisoning and procedural complications0/160/91/90/90/80/10
Subdural haematomaInjury, poisoning and procedural complications0/160/91/90/90/80/10
Adenocarcinoma of colonNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/161/90/90/90/80/10
AggressionPsychiatric disorders0/161/90/90/90/80/10
Gait disturbanceGeneral disorders0/160/90/90/90/81/10
FallInjury, poisoning and procedural complications0/160/90/90/90/81/10
Muscular weaknessMusculoskeletal and connective tissue disorders0/160/90/90/90/81/10
AtaxiaNervous system disorders0/160/90/90/90/81/10
DysarthriaNervous system disorders0/160/90/90/90/81/10
AgitationPsychiatric disorders0/160/90/90/90/81/10
Most frequent other events
Showing 10 of 109
Most frequent other events
EventPooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)
HeadacheNervous system disorders5/160/91/92/92/84/10
DizzinessNervous system disorders0/161/90/91/91/84/10
Back painMusculoskeletal and connective tissue disorders3/163/91/92/93/80/10
Procedural painInjury, poisoning and procedural complications3/160/92/93/91/82/10
FallInjury, poisoning and procedural complications0/161/91/91/92/81/10
Viral upper respiratory tract infectionInfections and infestations1/162/91/91/91/80/10
Post lumbar puncture syndromeInjury, poisoning and procedural complications2/161/92/90/91/80/10
ChoreaNervous system disorders1/160/90/92/90/80/10
Gait disturbanceGeneral disorders0/160/90/90/90/82/10
DysarthriaNervous system disorders0/160/90/90/90/82/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
<=18 years0000000
Between 18 and 65 years1599981060
>=65 years1000001
Sex: Female, Male
Sex: Female, Male(Participants)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
Female73561729
Male96437332
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
Hispanic or Latino0000000
Not Hispanic or Latino1699981061
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American0000000
White1699981061
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
Canada42210312
Denmark0001102
Poland47512019
Australia40063417
France1000124
Germany2000114
United Kingdom1020003
Time since initial diagnosis
Time since initial diagnosis(Years)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
Mean7 ± 6.934.9 ± 4.283.4 ± 6.373.2 ± 3.036.6 ± 6.098.7 ± 7.265.4 ± 5.80
Age at Disease Onset
Age at Disease Onset(Years)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
Mean40.75 ± 11.07937.33 ± 7.82642.89 ± 9.28046.11 ± 6.25444.88 ± 12.49544.60 ± 10.86543.16 ± 9.625
Diagnosis Stage
Diagnosis Stage(Participants)Pooled PlaceboWVE-120101 (2 mg)WVE-120101 (4 mg)WVE-120101 (8 mg)WVE-120101 (16 mg)WVE-120101 (32 mg)Total
Stage 197334733
Stage 272664328
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Study locations

21 sites
  • Westmead Hospital
    Sydney, New South Wales 2145, Australia
  • Royal Brisbane & Women's Hospital
    Herston, Queensland QLD 4006, Australia
  • Royal Melbourne Hospital
    Carlton, Victoria 3053, Australia
  • Monash Health
    Clayton, Victoria 3168, Australia
  • Alfred Health
    Melbourne, Victoria 3004, Australia
  • Calvary Health Care Bethlehem
    Parkdale, Victoria 3195, Australia
  • North Metropolitan Health Service
    Perth, Western Australia 6910, Australia
  • University of Alberta
    Edmonton, Alberta T6G 2B7, Canada
  • Centre For Movement Disorders
    Toronto, Ontario M3B 2S7, Canada
  • Center Hospitalier de l'Universite de Montreal
    Montreal, Quebec H2X0A9, Canada
  • Aarhus Universitets Hospital
    Aarhus, 8200, Denmark
  • Rigshospitalet
    Copenhagen, 2100, Denmark
  • Odense University Hospital and University of Southern Denmark
    Odense, 5000, Denmark
  • Hospital Henri Mondor
    Créteil, 94010, France
  • Institut du Cerveau et de la Moelle Epinière
    Paris, 75646, France
  • George-Huntington-Institut GmbH
    Münster, 48149, Germany
  • Szpital Sw. Wojciecha
    Gdansk, 80-462, Poland
  • Instytut Psychiatrii i Neurologii
    Warsaw, 02-957, Poland
  • Royal Devon and Exeter Hospital NHS Trust
    Exeter, Devon EX2 5DW, United Kingdom
  • Queen Elizabeth University Hospital - PPDS
    Glasgow, Glasgow City G12 0XH, United Kingdom
  • Royal Liverpool University Hospital
    Liverpool, L7 8XP, United Kingdom
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References and documents

Publications

  • Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: April 2020. J Huntingtons Dis. 2020;9(2):185-197. doi: 10.3233/JHD-200002. PubMed 32250312 ↗
  • Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: February 2018. J Huntingtons Dis. 2018;7(1):89-98. doi: 10.3233/JHD-189001. PubMed 29480210 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 21, 2020

Documents are hosted by the registry — open the source record to download them.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in May 2021, 45 months.

Results were first posted in Feb 2022, 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2017
First posted
Jul 21, 2017
StartActual
Jul 17, 2017
Primary completionActual
May 11, 2021
CompletionActual
May 11, 2021
Results first posted
Feb 10, 2022
Last update
Feb 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03225833
Lead sponsor
Wave Life Sciences USA, Inc.
Responsible party
Sponsor
First posted
Jul 21, 2017
Start date
Jul 17, 2017
Primary completion
May 11, 2021
Completion
May 11, 2021
Results posted
Feb 10, 2022
Last update
Feb 10, 2022

Study contacts

Medical Director, MD
study director · Wave Life Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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