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CompletedNCT05563246KRAKENUpdated Mar 25, 2025Results posted

A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

A Phase 2 interventional study of LY3473329 and Placebo in Lipoprotein Disorder, sponsored by Eli Lilly and Company. Completed at 42 sites in 8 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
233
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The main purpose of this study is to evaluate the efficacy and safety of LY3473329 in adult participants with elevated Lp(a) at high risk for cardiovascular events.

02

Conditions studied

  • Lipoprotein Disorder

Keywords

  • Atherosclerotic cardiovascular disease
  • ASCVD
  • Dyslipidemia
  • Lipoprotein(a)
  • Lp(a)
  • Cardiovascular
  • Cardiovascular disease
  • Cholesterol
  • Hyperlipidemia
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants must be at least 40 years old
  • Participants with Lp(a) ≥175 nmol/L at randomization, measured at the central laboratory.
  • High risk for cardiovascular events defined as documented coronary artery disease (CAD), stroke, or peripheral artery disease or atherosclerotic cardiovascular disease (ASCVD) risk equivalents (familial hypercholesterolemia or type 2 diabetes).

  • Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to randomization and expected to remain on a stable regimen through the end of the post-treatment follow-up period.

    • lipid-lowering drugs
    • testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
  • Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.
  • Males who agree to use highly effective or effective methods of contraception may participate in this trial.
  • Women of childbearing potential (WOCBP) who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial.

Exclusion criteria

Exclusion Criteria:

  • Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.

  • Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:

    • major surgery
    • coronary, carotid, or peripheral arterial revascularization
    • stroke or transient ischemic attack
    • myocardial infarction or unstable angina
    • acute limb ischemia
  • Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes
  • Have uncontrolled hypertension
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
233 participants (actual)

Study arms

  • Experimental
    10 mg LY3473329

    Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period.

    Drug: LY3473329

  • Experimental
    60 mg LY3473329

    Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.

    Drug: LY3473329

  • Experimental
    240 mg LY3473329

    Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.

    Drug: LY3473329

  • Placebo comparator
    Placebo

    Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.

    Drug: Placebo

Interventions

  • DrugLY3473329

    Administered orally

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay

    Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.

    Time frame: Baseline, Week 12

  2. Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay

    LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay

    The percentage of participants who achieved Lp(a) less than (\<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.

    Time frame: Week 12

  2. Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay

    The percentage of participants who achieved Lp(a) \< 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.

    Time frame: Week 12

  3. Percent Change From Baseline in Apolipoprotein B (ApoB)

    LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.

    Time frame: Baseline, Week 12

  4. Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.

    Time frame: Baseline, Week 12

  5. Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329

    C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered.

    Time frame: Week from randomization 1, 2, 8, 12: Pre-dose

07

Results

Posted Mar 25, 2025
Limitations and caveats
Due to country-specific restrictions on sample storage, measurements for the primary endpoint and key secondary endpoints involving Lp(a), as assessed by the intact Lp(a) assay, could not be obtained from participants at the Chinese sites. As a result, intact Lp(a) assay outcome data from these sites were not reported.

Participant flow

Participant flow — Overall Study
Milestone10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Started34646867
Received at least one dose of study drug34636867
Completed33606567
Not completed1430
Withdrew: Withdrawal by subject1200
Withdrew: Protocol deviation0100
Withdrew: Physician decision0100
Withdrew: Adverse event0020
Withdrew: Lost to follow-up0010

Outcome measures

PrimaryPercent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay

Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay
Percent change10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay-47.35 ± 4.811-81.57 ± 1.230-85.71 ± 0.9270.48 ± 6.382
Statistical analysis
  • 10 mg LY3473329 vs Placebo · Mixed Models Analysis · p = <.001 · Ls mean difference (final values): -47.61 · 95% CI -57.68 to -35.14
  • 60 mg LY3473329 vs Placebo · Mixed Models Analysis · p = <.001 · Ls mean difference (final values): -81.66 · 95% CI -84.62 to -78.13
  • 240 mg LY3473329 vs Placebo · Mixed Models Analysis · p = <.001 · Ls mean difference (final values): -85.77 · 95% CI -88.03 to -83.09
PrimaryPercent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay

LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay
Percent change10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay-42.26 ± 4.477-70.90 ± 1.669-69.88 ± 1.676-3.15 ± 5.342
Statistical analysis
  • 10 mg LY3473329 vs Placebo · Mixed Models Analysis · p = <.001 · Ls mean difference (final values): -40.38 · 95% CI -50.45 to -28.27
  • 60 mg LY3473329 vs Placebo · Mixed Models Analysis · p = <.001 · Ls mean difference (final values): -69.95 · 95% CI -74.23 to -64.96
  • 240 mg LY3473329 vs Placebo · Mixed Models Analysis · p = <.001 · Ls mean difference (final values): -68.90 · 95% CI -73.27 to -63.81
SecondaryPercentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay

The percentage of participants who achieved Lp(a) less than (\<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.

Time frame:
Week 12
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay
Percentage of participants10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay69.695.695.76.1
Statistical analysis
  • 10 mg LY3473329 vs Placebo · Regression, Logistic · p = <.001 · Risk difference (rd): 58.15 · 95% CI 40.30 to 75.99
  • 60 mg LY3473329 vs Placebo · Regression, Logistic · p = <.001 · Risk difference (rd): 89.87 · 95% CI 81.54 to 98.20
  • 240 mg LY3473329 vs Placebo · Regression, Logistic · p = <.001 · Risk difference (rd): 90.71 · 95% CI 82.80 to 98.62
SecondaryPercentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay

The percentage of participants who achieved Lp(a) \< 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.

Time frame:
Week 12
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay
Percentage of participants10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay37.982.177.23.3
Statistical analysis
  • 10 mg LY3473329 vs Placebo · Regression, Logistic · p = <.001 · Risk difference (rd): 35.18 · 95% CI 18.90 to 51.46
  • 60 mg LY3473329 vs Placebo · Regression, Logistic · p = <.001 · Risk difference (rd): 78.18 · 95% CI 67.70 to 88.65
  • 240 mg LY3473329 vs Placebo · Regression, Logistic · p = <.001 · Risk difference (rd): 73.62 · 95% CI 63.65 to 83.58
SecondaryPercent Change From Baseline in Apolipoprotein B (ApoB)

LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Apolipoprotein B (ApoB)
Percent change10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Percent Change From Baseline in Apolipoprotein B (ApoB)-10.49 ± 4.349-14.53 ± 3.055-17.56 ± 2.877-1.70 ± 3.362
Statistical analysis
  • 10 mg LY3473329 vs Placebo · Mixed Models Analysis · p = 0.110 · Ls mean difference (final values): -8.94 · 95% CI -18.84 to 2.17
  • 60 mg LY3473329 vs Placebo · Mixed Models Analysis · p = 0.004 · Ls mean difference (final values): -13.05 · 95% CI -20.92 to -4.40
  • 240 mg LY3473329 vs Placebo · Mixed Models Analysis · p = <.001 · Ls mean difference (final values): -16.13 · 95% CI -23.69 to -7.84
SecondaryPercent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Percent change10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)21.87 ± 20.029-2.41 ± 11.713-15.39 ± 9.921-9.91 ± 10.526
Statistical analysis
  • 10 mg LY3473329 vs Placebo · Mixed Models Analysis · p = 0.131 · Ls mean difference (final values): 35.27 · 95% CI -8.63 to 100.27
  • 60 mg LY3473329 vs Placebo · Mixed Models Analysis · p = 0.627 · Ls mean difference (final values): 8.32 · 95% CI -21.62 to 49.70
  • 240 mg LY3473329 vs Placebo · Mixed Models Analysis · p = 0.701 · Ls mean difference (final values): -6.08 · 95% CI -31.89 to 29.51
SecondaryPharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329

C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered.

Time frame:
Week from randomization 1, 2, 8, 12: Pre-dose
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329
nanograms per milliliter (ng/mL)10 mg LY347332960 mg LY3473329240 mg LY3473329
Week 113.0 ± 8142.4 ± 7983.3 ± 70
Week 214.8 ± 7339.3 ± 7677.9 ± 62
Week 814.5 ± 6738.8 ± 8973.9 ± 110
Week 1215.4 ± 6437.7 ± 9574.0 ± 111

Adverse events

Collected over Baseline to end of follow-up (up to 16 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
10 mg LY34733290/34 (0%)2/34 (5.9%)7/34 (20.6%)
60 mg LY34733290/63 (0%)2/63 (3.2%)5/63 (7.9%)
240 mg LY34733290/68 (0%)2/68 (2.9%)10/68 (14.7%)
Placebo0/67 (0%)4/67 (6%)11/67 (16.4%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
Event10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
Lower limb fractureInjury, poisoning and procedural complications1/340/630/680/67
BursitisMusculoskeletal and connective tissue disorders1/340/630/680/67
PriapismReproductive system and breast disorders0/230/411/440/48
Atrial fibrillationCardiac disorders0/341/630/680/67
DizzinessNervous system disorders0/341/630/680/67
SyncopeNervous system disorders0/341/630/680/67
ConcussionInjury, poisoning and procedural complications0/340/630/681/67
Wrist fractureInjury, poisoning and procedural complications0/340/630/681/67
Peripheral arterial occlusive diseaseVascular disorders0/340/630/681/67
Peripheral vascular haematomaVascular disorders0/340/630/681/67
Most frequent other events
Most frequent other events
Event10 mg LY347332960 mg LY3473329240 mg LY3473329Placebo
DiarrhoeaGastrointestinal disorders0/341/634/684/67
AnaemiaBlood and lymphatic system disorders2/340/630/680/67
NauseaGastrointestinal disorders2/341/630/683/67
InfluenzaInfections and infestations2/341/631/681/67
OverdoseInjury, poisoning and procedural complications0/342/634/681/67
Back painMusculoskeletal and connective tissue disorders2/340/630/682/67
MyalgiaMusculoskeletal and connective tissue disorders2/341/631/680/67
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/110/220/241/19

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)10 mg LY347332960 mg LY3473329240 mg LY3473329PlaceboTotal
Mean64.06 ± 10.0165.50 ± 9.3664.75 ± 9.3562.78 ± 9.9364.29 ± 9.61
Sex: Female, Male
Sex: Female, Male(Participants)10 mg LY347332960 mg LY3473329240 mg LY3473329PlaceboTotal
Female1122241976
Male23424448157
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)10 mg LY347332960 mg LY3473329240 mg LY3473329PlaceboTotal
Hispanic or Latino41110934
Not Hispanic or Latino30505758195
Unknown or Not Reported03104
Race (NIH/OMB)
Race (NIH/OMB)(Participants)10 mg LY347332960 mg LY3473329240 mg LY3473329PlaceboTotal
American Indian or Alaska Native00000
Asian917191863
Native Hawaiian or Other Pacific Islander10001
Black or African American25119
White22414545153
More than one race01337
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)10 mg LY347332960 mg LY3473329240 mg LY3473329PlaceboTotal
Australia612121242
Brazil613121243
China489930
Germany458724
Hungary611111139
Japan488929
Netherlands233412
United States245314
Lp(a) - Assessed via Intact Lp(a) Assay
Lp(a) - Assessed via Intact Lp(a) Assay(nanomoles per liter (nmol/L))10 mg LY347332960 mg LY3473329240 mg LY3473329PlaceboTotal
Mean220.99 ± 60.39223.47 ± 97.36242.42 ± 100.18250.53 ± 96.66236.63 ± 93.74
Lp(a) - Assessed via Apo(a) Assay
Lp(a) - Assessed via Apo(a) Assay(nanomoles per liter (nmol/L))10 mg LY347332960 mg LY3473329240 mg LY3473329PlaceboTotal
Mean269.67 ± 78.10256.28 ± 96.55273.84 ± 90.68265.30 ± 85.80265.99 ± 88.93
08

Study locations

42 sites
  • Care Access - Baltimore
    Baltimore, Maryland 21213, United States
  • Care Access - Dorchester
    Dorchester, Massachusetts 02124, United States
  • Care Access - Lima
    Lima, Ohio 45805, United States
  • Core Research Group
    Brisbane, Queensland 4064, Australia
  • Nightingale Research
    Adelaide, South Australia 5000, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Victorian Heart Hospital
    Clayton, Victoria 3168, Australia
  • CEDOES
    Vitória, Espírito Santo 29055450, Brazil
  • Pesquisa Clínica em Diabetes - Dra Rosângela Réa
    Curitiba, Paraná 80040-110, Brazil
  • Centro de Pesquisa Clinica do Coracao
    Acaraju, Sergipe 49055-530, Brazil
  • Incor - Instituto do Coracao
    Sao Paulo, São Paulo 05403-900, Brazil
  • IBPClin - Instituto Brasil de Pesquisa Clínica
    Rio de Janeiro, 22241-180, Brazil
  • CPCLIN
    Sao Paulo, 01228-200, Brazil
  • Instituto Dante Pazzanese de Cardiology
    São Paulo, 04012-909, Brazil
  • CEPIC - Centro Paulista de Investigação Clínica
    São Paulo, 04266-010, Brazil
  • Third People's Hospital of Hainan Province
    Sanya, Hainan 572000, China
  • The First Hospital of Harbin Medical University
    Harbin, Heilongjiang 150001, China
  • The Fourth Hospital of Harbin Medical University
    Harbin, Heilongjiang 150001, China
  • Changzhou Second People's Hospital
    Changzhou, Jiangsu 213000, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
  • The Third Hospital of Nanchang
    Nanchang, Jiangxi 330009, China
  • China-Japan Union Hospital
    Changchun, Jilin 130033, China
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
  • Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
    Mühldorf, Bayern 84453, Germany
  • ClinPhenomics GmbH & Co KG
    Frankfurt, Hessen 60596, Germany
  • Kath. St.-Johannes-Gesellschaft Dortmund
    Dortmund, Nordrhein-Westfalen 44137, Germany
  • Private Practice - Dr. Frank Menzel
    Dessau, 06846, Germany
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
    Szeged, Csongrád 6720, Hungary
  • Medifarma 98 Kft
    Nyiregyhaza, Nyíregyháza 4400, Hungary
  • Flor Ferenc Hospital of Pest County
    Kistarcsa, Pest 2143, Hungary
  • Belvárosi Egészségház
    Zalaegerszeg, Zala 8900, Hungary
  • Dél-Pesti Centrumkórház
    Budapest, 1097, Hungary
  • Semmelweis University
    Budapest, 1122, Hungary
  • Funabashi Municipal Medical Center
    Funabashi, Chiba 273-0853, Japan
  • Kokura Memorial Hospital
    Kitakyushu, Fukuoka 802-8555, Japan
  • Iwate Prefectural Central Hospital
    Morioka, Iwate 020-0066, Japan
  • Medical Corporation Heishinkai OCROM Clinic
    Suita-shi, Osaka 565-0853, Japan
  • Minamino Cardiovascular Hospital
    Hachioji, Tokyo 192-0918, Japan
  • Hiroshima City Hospital
    Hiroshima, 730-8518, Japan
  • Miyazaki Medical Association Hospital
    Miyazaki, 880-2102, Japan
  • VieCuri Medisch Centrum, locatie Venlo
    Venlo, Limburg 5912 BL, Netherlands
  • Meander Medisch Centrum
    Amersfoort, Utrecht 3813 TZ, Netherlands
09

References and documents

Study documents

  • Study protocol · Jul 28, 2022
  • Statistical analysis plan · Sep 20, 2023

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

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05563246
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 3, 2022
Start date
Nov 24, 2022
Primary completion
Mar 14, 2024
Completion
Mar 14, 2024
Results posted
Mar 25, 2025
Last update
Mar 25, 2025

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

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

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