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CompletedNCT04052516ICONAUpdated Feb 28, 2025Results posted

A Phase 2b Study of Icosabutate in Fatty Liver Disease

A Phase 2 interventional study of Icosabutate and Placebo in Non Alcoholic Steatohepatitis (NASH), sponsored by NorthSea Therapeutics B.V.. Completed at 39 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by NorthSea Therapeutics B.V. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis

Read the detailed description

This is a 62 week (including screening and follow-up), multicenter, randomized, double blind, placebo-controlled, parallel group study in male and female patients with a histological diagnosis of NASH. The study includes a screening period, double blind treatment period, and post-treatment follow up

02

Conditions studied

  • Non Alcoholic Steatohepatitis (NASH)
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 280 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

NorthSea Therapeutics B.V. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Provides signed written informed consent and agrees to comply with the study protocol.
  • Is a male or female aged 18 to 75 years, inclusive.
  • Has a histological diagnosis of NASH prior to study entry
  • Has (NAS) greater than or equal to 4, with a score of at least 1 in each component (steatosis, lobular inflammation, and ballooning),
  • Has a fibrosis score F1 to F3, inclusive (F1 capped at 30%),
  • Has a Proton Density Fat Fraction (PDFF) greater than or equal to 10% on MRI at screening

Exclusion criteria

Exclusion Criteria:

  • Has a known history of alcohol abuse or daily heavy alcohol consumption
  • Has had bariatric surgery within the past 5 years
  • Has significant systemic or major illnesses other than liver disease
  • Has a recent (within 6 months) history of cardiac dysrhythmias and/or cardiovascular disease
  • Has uncontrolled arterial hypertension
  • Positive for Hep B, Hepatitis C Virus (HCV) or HCV Polymerase Chain Reaction (PCR)
  • Has type 1 diabetes mellitus
  • Has diabetic ketoacidosis
  • Has a history of liver decompensation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
280 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo oral capsules taken one daily for 52 weeks

    Drug: Placebo

  • Experimental
    Icosabutate 300mg

    Icosabutate 300mg oral capsule taken once daily for 52 weeks

    Drug: Icosabutate

  • Experimental
    Icosabutate 600mg

    Icosabutate 600mg oral capsules taken once daily for 52 weeks

    Drug: Icosabutate

Interventions

  • DrugIcosabutate

    Icosabutate oral capsule once daily

    Also known as: NST-4016

  • DrugPlacebo

    Matching placebo oral capsule

06

What researchers measure

Primary outcomes

  1. Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis.

    Time frame: 52 weeks

Secondary outcomes

  1. Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning).

    Time frame: 52 weeks

  2. Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.

    Time frame: 52 weeks

  3. Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline

    Time frame: 52 weeks

  4. Change in Bilirubin Micromol/L From Baseline

    Time frame: 52 weeks

  5. Change From Baseline in Inflammation Marker hsCRP

    Time frame: 52 weeks

  6. Change From Baseline in Fibrosis Activity Marker Pro-C3

    Time frame: 52 weeks

  7. Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test

    ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter.

    Time frame: 52 weeks

  8. Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose \[mmol/L)\] × fasting insulin \[mIU/L\]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range.

    Time frame: 52 weeks

  9. Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)

    The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease.

    Time frame: 52 weeks

  10. Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)

    A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease

    Time frame: 52 weeks

  11. Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline

    Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity

    Time frame: 52 weeks

  12. Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)

    MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity.

    Time frame: 52 weeks

07

Results

Posted Feb 28, 2025

Participant flow

Participant flow — Overall Study
MilestonePlaceboIcosabutate 300mgIcosabutate 600mg
Started929395
Safety population919295
Itt919295
Mitt757677
3-panel mitt757677
Completed797878
Not completed131517
Withdrew: Withdrawal by subject456
Withdrew: Adverse event328
Withdrew: Lost to follow-up253
Withdrew: Protocol violation110
Withdrew: Death100
Withdrew: Physician decision010
Withdrew: Pregnancy100
Withdrew: Requirement of prohibited concomitant medication100
Withdrew: Reason not recorded010

Outcome measures

PrimaryPercentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis.
Time frame:
52 weeks
Reported as:
Number · percentage of participants
Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis.
percentage of participantsPlaceboIcosabutate 300mgIcosabutate 600mg
Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis.8.717.320.8
Statistical analysis
  • Placebo vs Icosabutate 300mg · Cochran-Mantel-Haenszel · p = 0.2991 · Odds ratio (or): 1.70 · 95% CI 0.62 to 4.63
  • Placebo vs Icosabutate 600mg · Cochran-Mantel-Haenszel · p = 0.1386 · Odds ratio (or): 2.01 · 95% CI 0.80 to 5.08
SecondaryPercentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning).
Time frame:
52 weeks
Reported as:
Number · percentage of participants
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning).
percentage of participantsPlaceboIcosabutate 300mgIcosabutate 600mg
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning).13.026.924.5
SecondaryPercentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.
Time frame:
52 weeks
Reported as:
Number · percentage of participants
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.
percentage of participantsPlaceboIcosabutate 300mgIcosabutate 600mg
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.13.030.828.3
SecondaryChanges in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline
Time frame:
52 weeks
Reported as:
Least squares mean · U/L
Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline
U/LPlaceboIcosabutate 300mgIcosabutate 600mg
Aspartate Aminotransferase-8.2 ± 3.18-14.9 ± 3.46-18.5 ± 3.13
Alanine Aminotransferase-9.8 ± 3.73-27.9 ± 4.05-30.1 ± 3.65
Gamma Glutamyl Transferase-5.1 ± 5.41-27.9 ± 5.75-32.7 ± 5.26
SecondaryChange in Bilirubin Micromol/L From Baseline
Time frame:
52 weeks
Reported as:
Least squares mean · micromol/L
Change in Bilirubin Micromol/L From Baseline
micromol/LPlaceboIcosabutate 300mgIcosabutate 600mg
Change in Bilirubin Micromol/L From Baseline0.56 ± 0.332-1.11 ± 0.362-1.49 ± 0.325
SecondaryChange From Baseline in Inflammation Marker hsCRP
Time frame:
52 weeks
Reported as:
Least squares mean · mg/L
Change From Baseline in Inflammation Marker hsCRP
mg/LPlaceboIcosabutate 300mgIcosabutate 600mg
Change From Baseline in Inflammation Marker hsCRP1.089 ± 0.8095-1.297 ± 0.8953-3.382 ± 0.7978
SecondaryChange From Baseline in Fibrosis Activity Marker Pro-C3
Time frame:
52 weeks
Reported as:
Least squares mean · micrograms/L
Change From Baseline in Fibrosis Activity Marker Pro-C3
micrograms/LPlaceboIcosabutate 300mgIcosabutate 600mg
Change From Baseline in Fibrosis Activity Marker Pro-C3-4.33 ± 2.830-3.68 ± 3.023-11.76 ± 2.762
SecondaryChange From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test

ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter.

Time frame:
52 weeks
Reported as:
Least squares mean · score
Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test
scorePlaceboIcosabutate 300mgIcosabutate 600mg
Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test-0.051 ± 0.0993-0.125 ± 0.1087-0.370 ± 0.0983
SecondaryChange From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose \[mmol/L)\] × fasting insulin \[mIU/L\]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range.

Time frame:
52 weeks
Reported as:
Least squares mean · score
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
scorePlaceboIcosabutate 300mgIcosabutate 600mg
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)0.609 ± 1.3453-2.810 ± 1.4733-3.794 ± 1.3203
SecondaryChange From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)

The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease.

Time frame:
52 weeks
Reported as:
Mean · score on a scale
Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)
score on a scalePlaceboIcosabutate 300mgIcosabutate 600mg
Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)-0.2 ± 1.68-0.7 ± 1.84-0.9 ± 1.56
SecondaryChange From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)

A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease

Time frame:
52 weeks
Reported as:
Mean · score on a scale
Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
score on a scalePlaceboIcosabutate 300mgIcosabutate 600mg
Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)-0.9 ± 1.36-0.9 ± 1.51-1.3 ± 1.65
SecondaryChanges in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline

Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity

Time frame:
52 weeks
Reported as:
Mean · score on a scale
Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline
score on a scalePlaceboIcosabutate 300mgIcosabutate 600mg
Steatosis grade-0.4 ± 0.62-0.2 ± 0.65-0.4 ± 0.81
Lobular inflammation score-0.2 ± 0.62-0.4 ± 0.67-0.5 ± 0.61
Hepatocyte ballooning score-0.3 ± 0.79-0.3 ± 0.84-0.4 ± 0.78
SecondaryChange From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)

MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity.

Time frame:
52 weeks
Reported as:
Mean · Percentage of fat
Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)
Percentage of fatPlaceboIcosabutate 300mgIcosabutate 600mg
Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)-4.37 ± 7.185-1.33 ± 5.356-0.95 ± 8.206

Adverse events

Collected over AEs, which included clinical laboratory test variables, were monitored and documented from the time the patient signed the ICF until Visit 10 (Week 54) or the Early Termination visit (if applicable).. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo1/91 (1.1%)4/91 (4.4%)82/91 (90.1%)
Icosabutate 300mg0/92 (0%)5/92 (5.4%)80/92 (87%)
Icosabutate 600mg1/95 (1.1%)8/95 (8.4%)80/95 (84.2%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventPlaceboIcosabutate 300mgIcosabutate 600mg
CellulitisInfections and infestations0/910/922/95
Coronavirus infectionInfections and infestations1/911/920/95
Transient ischemic attackNervous system disorders1/910/921/95
Post-procedural hematomaInjury, poisoning and procedural complications1/910/920/95
Bladder transitional cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/910/920/95
Abdominal painGastrointestinal disorders0/911/920/95
DiarrheaGastrointestinal disorders0/911/920/95
Intra-abdominal hematomaInfections and infestations0/911/920/95
Food allergyImmune system disorders0/911/920/95
DiverticulitisInfections and infestations0/910/921/95
Most frequent other events
Showing 10 of 44
Most frequent other events
EventPlaceboIcosabutate 300mgIcosabutate 600mg
NauseaGastrointestinal disorders4/9113/9222/95
DiarrheaGastrointestinal disorders13/9113/9215/95
Urinary tract infectionGastrointestinal disorders8/9113/929/95
Coronavirus infectionInfections and infestations11/9110/926/95
Abdominal pain upperGastrointestinal disorders3/915/929/95
ConstipationGastrointestinal disorders7/910/927/95
HeadacheNervous system disorders7/914/926/95
Type 2 diabetes mellitusMetabolism and nutrition disorders6/917/923/95
Abdominal painGastrointestinal disorders6/915/923/95
Diabetes mellitusMetabolism and nutrition disorders6/913/924/95

Baseline characteristics

The Modified Intent-To-Treat (mITT) Population is used for the baseline analysis population as this was the primary population for efficacy analysis. The mITT Population included all patients from the ITT Population who had valid baseline and Week 52 (or ET, if applicable) liver biopsy measurements; a valid Week 52/ET liver biopsy was defined as a liver biopsy that had occurred within 90 days of last dose/Week 52 visit.

Age, Continuous
Age, Continuous(years)PlaceboIcosabutate 300mgIcosabutate 600mgTotal
Mean54.0 ± 11.1553.3 ± 10.5251.8 ± 10.2653.0 ± 10.64
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboIcosabutate 300mgIcosabutate 600mgTotal
Female525551158
Male23212670
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboIcosabutate 300mgIcosabutate 600mgTotal
Hispanic or Latino32312992
Not Hispanic or Latino424445131
Unknown or Not Reported1135
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboIcosabutate 300mgIcosabutate 600mgTotal
American Indian or Alaska Native2013
Asian0101
Native Hawaiian or Other Pacific Islander0000
Black or African American1258
White727271215
More than one race0000
Unknown or Not Reported0101
Body mass index
Body mass index(kg/m^2)PlaceboIcosabutate 300mgIcosabutate 600mgTotal
Mean35.94 ± 6.23036.73 ± 5.73237.32 ± 6.04736.67 ± 6.006
Alcohol use
Alcohol use(Participants)PlaceboIcosabutate 300mgIcosabutate 600mgTotal
Current444040124
Former1081230
Never20282573
Missing1001
Type 2 Diabetes status
Type 2 Diabetes status(Participants)PlaceboIcosabutate 300mgIcosabutate 600mgTotal
Diabetic354039114
Non-diabetic403638114
08

Study locations

39 sites
  • Central ResearchAssociates Inc.
    Birmingham, Alabama 35205, United States
  • Arizona Liver Health
    Chandler, Arizona 85224, United States
  • Arizona Liver Health - Glendale
    Glendale, Arizona 85306, United States
  • Arizona Liver Health
    Tucson, Arizona 85711, United States
  • Adobe Clinical Research, LLC
    Tucson, Arizona 85712, United States
  • Arkansas Gastroenterology - North Little Rock
    North Little Rock, Arkansas 72117, United States
  • Fresno Clinical Research Center
    Fresno, California 93720, United States
  • National Research Institute - Huntington Park
    Huntington Park, California 90255, United States
  • National Research Institute - Wilshire
    Los Angeles, California 90057, United States
  • National Research Institute - Panorama
    Panorama City, California 91402, United States
  • Alliance Clinical Research
    Poway, California 92064, United States
  • National Research Institute - Santa Ana
    Santa Ana, California 92704, United States
  • South Denver Gastroenterology
    Englewood, Colorado 80113, United States
  • Excel Medical Clinical Trials, LLC
    Boca Raton, Florida 33434, United States
  • Sensible Healthcare LLC
    Ocoee, Florida 34761, United States
  • Covenant Research LLC
    Sarasota, Florida 34240, United States
  • Gastrointestinal Specialists of Georgia PC
    Marietta, Georgia 30060, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Texas Digestive Disease Consultants
    Baton Rouge, Louisiana 70809, United States
  • Tandem Clinical Research
    Marrero, Louisiana 70072, United States
  • Gastrointestinal Associates, PA
    Flowood, Mississippi 39232, United States
  • Southern Therapy and Advanced Research LLC
    Jackson, Mississippi 39216, United States
  • Kansas City Research Institute
    Kansas City, Missouri 64131, United States
  • Cumberland Research Associates, LLC
    Fayetteville, North Carolina 28304, United States
  • Aventiv Research, Inc.
    Columbus, Ohio 43213, United States
  • Premier Research
    Clarksville, Tennessee 37040, United States
  • Gastro One
    Germantown, Tennessee 38138, United States
  • Pinnacle Clinical Research
    Austin, Texas 78746, United States
  • Texas Digestive Disease Consultants
    Dallas, Texas 75246, United States
  • South Texas Research Institute
    Edinburg, Texas 78539, United States
  • Liver Associates of Texas
    Houston, Texas 77030, United States
  • Doctors Hospital at Renaissance, LLC
    McAllen, Texas 78504, United States
  • Quality Research Inc
    San Antonio, Texas 78209, United States
  • American Research Corporation
    San Antonio, Texas 78215, United States
  • Pinnacle Clinical Research
    San Antonio, Texas 78229, United States
  • Brooke Army Medical Center
    San Antonio, Texas 78234, United States
  • Texas Digestive Disease Consultants - Webster
    Webster, Texas 77598, United States
  • Hunter Holmes McGuire VA Medical Center
    Richmond, Virginia 23249, United States
  • Fundacion de Investigacion (FDI)
    San Juan, 00927-4807, Puerto Rico
09

References and documents

Study documents

  • Study protocol · Jul 21, 2022
  • Statistical analysis plan · Feb 14, 2023

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

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04052516
Lead sponsor
NorthSea Therapeutics B.V.
Responsible party
Sponsor
First posted
Aug 9, 2019
Start date
Jul 17, 2019
Primary completion
Feb 20, 2022
Completion
Dec 19, 2022
Results posted
Feb 28, 2025
Last update
Feb 28, 2025

Oversight

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

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