Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Other: Placebo; Drug: COR-001

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Northridge, California, United States, 91324
      • Novo Nordisk Investigational Site
  • Florida
    • Hollywood, Florida, United States, 33025
      • Novo Nordisk Investigational Site
    • Tampa, Florida, United States, 33614
      • Novo Nordisk Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Novo Nordisk Investigational Site
  • New Jersey
    • North Brunswick, New Jersey, United States, 08902
      • Novo Nordisk Investigational Site
  • New York
    • Astoria, New York, United States, 11102
      • Novo Nordisk Investigational Site
    • Fresh Meadows, New York, United States, 11365
      • Novo Nordisk Investigational Site
    • Great Neck, New York, United States, 11021
      • Novo Nordisk Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02915
      • Novo Nordisk Investigational Site
  • Texas
    • Houston, Texas, United States, 77099
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78215
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

1. Age greater than or equal to 18 years at the time of signing of the ICF.
2. The patient agrees to comply with the contraception and reproduction restrictions of the study
3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
4. At least 2 ferritin values during Screening > 300 ng/mL
5. At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)

EXCLUSION CRITERIA:

1. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
2. Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
3. Actively treated or active malignancy
4. Known or suspected occult or active bleeding
5. Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo
Experimental: COR-001	Drug: COR-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of Maximum Tolerated Dose (MTD)	The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline; Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia.; ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase); ≥ Grade 4 hematologic toxicity; ≥ Grade 3 non-hematologic toxicity	Weeks 0-24
Change in High-sensitivity C-reactive Protein (hsCRP): Week 4	Change from the baseline in hsCRP values to week 4 are presented.	From baseline (mean of screening and day 1) to week 4
Change in Serum Amyloid A (SAA): Week 4	Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.	From baseline (mean of screening and day 1) to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events of Special Interest	Frequency of events of interest by treatment group and dose from baseline until the end of the safety follow-up period (week 24) were reported. Adverse events of special interest included severe infusion-related reactions, hypersensitivity reaction during study drug infusion, anaphylaxis and neutropenia events of grade 2 or higher (i.e., absolute neutrophil count <1500/mm^3 and decline by at least 25% from baseline).	Weeks 0-24
Number of Treatment Emergent Adverse Events (TEAEs)	An AE (adverse event) is any undesirable event or any untoward medical occurrence that occurs to a participant during the course of a study, or the protocol-defined time after study termination, whether or not that event is considered Study Drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of study. Number of TEAEs from baseline until the end of safety follow up (week 24) were presented.	Week 0-24
Electrocardiogram (ECG)	A summary of the overall ECG interpretation and clinical significance from baseline until the end of the safety follow up period (week 24) is presented and categorized as Normal, Abnormal clinically significant (CS), Abnormal non clinically significant (NCS) and Missing.	At baseline, week 6, week 12, week 18 and week 24
Number of Participants Who Developed Anti-drug Antibodies (ADAs)	Number of participants who developed ADAs from baseline until the end of the extended follow up period (week 35) were reported. Samples with detectable ADAs were classified as positive for ADAs. Samples without detectable ADAs were classified as negative for ADAs.	Weeks 0-35
Number of Participants With ADA Titers	Number of participants with ADA titers for ADA-positive samples from baseline to week 35 is presented.	Weeks 0-35
Number of Participants With Neutralizing ADAs	Number of participants with neutralizing ADAs from baseline to week 35 are presented.	From baseline (mean of screening and week 1) to week 35
Change in Transferrin Saturation (TSAT): Week 4	Change from baseline in TSAT to week 4 is presented.	From baseline (mean of screening and day 1) to week 4
Change in TSAT: Mean of Weeks 10-12	Change from baseline in TSAT to the mean of weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Change in Reticulocyte Hemoglobin (CHr): Week 4	Change from baseline in CHr to week 4 is presented.	From baseline (mean of screening and day 1) to week 4
Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks	Change from baseline in hs-CRP to the mean of 10-12 weeks is presented.	From baseline (mean of screening and day 1), week 10, week 12
Change in SAA: Mean of Weeks 10-12	Change from baseline in SAA to the mean of weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Change in Serum Pre-albumin: Mean of 10-12 Weeks	Change from baseline in serum pre-albumin to the mean of 10-12 weeks is presented.	From baseline (mean of screening and day 1), week 10, week 12
Change in Albumin: Week 12	Change from baseline in albumin to week 12 is presented.	From baseline (mean of screening and day 1) to week 12
Change in Erythropoietin Resistance Index (ERI): Week 4	Change from baseline in ERI to week 4 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening) to week 4
Change in ERI: Mean of Weeks 8-12	Change from baseline in ERI to the mean of weeks 8-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening), week 8, week 12
Change in ERI: Mean of Weeks 10-12	Change from baseline in ERI to the mean of weeks 10-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening), week 10, week 12
Change in CHr: Mean of Weeks 10-12	Change from baseline in CHr to the mean of weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Change in Hemoglobin: Week 4	Change from baseline in hemoglobin to week 4 is presented.	From baseline (mean of screening and day 1) to week 4
Change in Hemoglobin: Mean of Weeks 10-12	Change from baseline in hemoglobin to weeks 10-12 is presented.	From baseline (mean of screening and day 1), week 10, week 12
Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose	Change from baseline in hemoglobin to weeks 10-12, excluding hemoglobin values following a change in the total weekly ESA (erythropoiesis stimulating agent) dose is presented. A change is defined as the first time when the ESA weekly dose goes up by >25% or down by >25% relative to the previous week's dose.	From baseline (mean of screening and day 1), week 10, week 12
Change in ERI: Week 12	Change from baseline in ERI to week 12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening) to week 12
Change in ERI: Mean of Weeks 9-12	Change from baseline in ERI to the mean of weeks 9-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).	From baseline (weekly mean of screening), week 9, week 12
Change in Hemoglobin: Week 12	Change from baseline in hemoglobin to week 12 is presented.	From baseline (mean of screening and day 1) to week 12
Change in Hemoglobin: Week 24	Change from baseline in hemoglobin to week 24 is presented.	From baseline (mean of screening and day 1) to week 24
Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4	Change in hemoglobin from screening to peak hemoglobin at week 4 is presented.	From screening to week 4
Basophils: Week 12	The observed values of basophils at week 12 are presented.	At week 12
Basophil: Week 24	The observed values of basophils at week 24 are presented.	At week 24
Basophils to Leukocytes Ratio: Week 12	Basophils to leukocytes ratio at week 12 is presented.	At week 12
Basophils to Leukocytes Ratio: Week 24	Basophils to leukocytes ratio at week 24 is presented.	At week 24
Eosinophils: Week 12	The observed values of eosinophils at week 12 are presented.	At week 12
Eosinophils: Week 24	The observed values of eosinophils at week 24 are presented.	At week 24
Eosinophils to Leukocytes Ratio: Week 12	Eosinophils to leukocytes ratio at week 12 is presented.	At week 12
Eosinophils to Leukocytes Ratio: Week 24	The eosinophils to leukocytes ratio at week 24 is presented.	At week 24
Erythrocyte Mean Corpuscular Hemoglobin: Week 12	The observed values of erythrocyte mean corpuscular hemoglobin at week 12 are presented.	At week 12
Erythrocyte Mean Corpuscular Hemoglobin: Week 24	The observed values of erythrocyte mean corpuscular hemoglobin at week 24 are presented.	At week 24
Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12	The observed values of erythrocyte mean corpuscular HGB concentration at week 12 are presented.	At week 12
Erythrocyte Mean Corpuscular HGB Concentration: Week 24	The observed values of erythrocyte mean corpuscular HGB concentration at week 24 are presented.	At week 24
Erythrocyte Mean Corpuscular Volume: Week 12	The observed values of erythrocyte mean corpuscular volume at week 12 are presented.	At week 12
Erythrocyte Mean Corpuscular Volume: Week 24	The observed values of erythrocyte mean corpuscular volume at week 24 are presented.	At week 24
Erythrocytes: Week 12	The observed values of erythrocytes at week 12 are presented.	At week 12
Erythrocytes: Week 24	The observed values of erythrocytes at week 24 are presented.	At week 24
Hematocrit: Week 12	The observed values of hematocrit at week 12 are presented.	At week 12
Hematocrit: Week 24	The observed values of hematocrit at week 24 are presented.	At week 24
Hemoglobin: Week 12	The observed values of hemoglobin at week 12 are presented.	At week 12
Hemoglobin: Week 24	The observed values of hemoglobin at week 24 are presented.	At week 24
Hypochromatic Red Cells Week 12	The observed values of hypochromatic red cells at week 12 are presented.	At week 12
Hypochromatic Red Cells: Week 24	The observed values of hypochromatic red cells at week 24 are presented.	At week 24
Leukocytes: Week 12	The observed values of leukocytes at week 12 are presented.	At week 12
Leukocytes: Week 24	The observed values of leukocytes at week 24 are presented.	At week 24
Lymphocytes: Week 12	The observed values of lymphocytes at week 12 are presented.	At week 12
Lymphocytes: Week 24	The observed values of lymphocytes at week 24 are presented.	At week 24
Lymphocytes to Leukocytes Ratio: Week 12	Lymphocytes to leukocytes ratio at week 12 is presented.	At week 12
Lymphocytes to Leukocytes Ratio at Week 24	Lymphocytes to leukocytes ratio at week 24 is presented.	At week 24
Monocytes: Week 12	The observed values of monocytes at week 12 are presented.	At week 12
Monocytes: Week 24	The observed values of monocytes at week 24 are presented.	At week 24
Monocytes to Leukocytes Ratio: Week 12	Monocytes to leukocytes ratio at week 12 is presented.	At week 12
Monocytes to Leukocytes Ratio: Week 24	Monocytes to leukocytes ratio at week 24 is presented.	At week 24
Neutrophils: Week 12	The observed values of neutrophils at week 12 are presented.	At week 12
Neutrophils: Week 24	The observed values of neutrophils at week 24 are presented.	At week 24
Neutrophils to Leukocytes Ratio: Week 12	Neutrophils to leukocytes ratio at week 12 is presented.	At week 12
Neutrophils to Leukocytes Ratio: Week 24	Neutrophils to leukocytes ratio at week 24 is presented.	At week 24
Platelets: Week 12	The observed values of platelets at week 12 are presented.	At week 12
Platelets: Week 24	The observed values of platelets at week 24 are presented.	At week 24
Reticulocytes to Erythrocytes Ratio: Week 12	Reticulocytes to erythrocytes ratio at week 12 is presented.	At week 12
Reticulocytes to Erythrocytes Ratio: Week 24	Reticulocytes to erythrocytes ratio at week 24 is presented.	At week 24
Alanine Aminotransferase: Week 12	The observed values of alanine aminotransferase at week 12 are presented.	At week 12
Alanine Aminotransferase: Week 24	The observed values of alanine aminotransferase at week 24 are presented.	At week 24
Albumin: Week 12	The observed values of albumin at week 12 are presented.	At week 12
Albumin: Week 24	The observed values of albumin at week 24 are presented.	At week 24
Alkaline Phosphatase: Week 12	The observed values of alkaline phosphatase at week 12 are presented.	At week 12
Alkaline Phosphatase: Week 24	The observed values of alkaline phosphatase at week 24 are presented.	At week 24
Aspartate Aminotransferase: Week 12	The observed values of aspartate aminotransferase at week 12 are presented.	At week 12
Aspartate Aminotransferase: Week 24	The observed values of aspartate aminotransferase at week 24 are presented.	At week 24
Bicarbonate: Week 12	The observed values of bicarbonate at week 12 are presented.	At week 12
Bicarbonate: Week 24	The observed values of bicarbonate at week 24 are presented.	At week 24
Bilirubin: Week 12	The observed values of bilirubin at week 12 are presented.	At week 12
Bilirubin: Week 24	The observed values of bilirubin at week 24 are presented.	At week 24
Calcium: Week 12	The observed values of calcium at week 12 are presented.	At week 12
Calcium: Week 24	The observed values of calcium at week 24 are presented.	At week 24
Chloride: Week 12	The observed values of chloride at week 12 are presented.	At week 12
Chloride: Week 24	The observed values of chloride at week 24 are presented.	At week 24
Cholesterol: Week 12	The observed values of cholesterol at week 12 are presented.	At week 12
Cholesterol: Week 24	The observed values of cholesterol at week 24 are presented.	At week 24
Creatinine: Week 12	The observed values of creatinine at week 12 are presented.	At week 12
Creatinine: Week 24	The observed values of creatinine at week 24 are presented.	At week 24
Direct Bilirubin: Week 12	The observed values of direct bilirubin at week 12 are presented.	At week 12
Direct Bilirubin: Week 24	The observed values of direct bilirubin at week 24 are presented.	At week 24
Glucose: Week 12	The observed values of glucose at week 12 are presented.	At week 12
Glucose: Week 24	The observed values of glucose at week 24 are presented.	At week 24
High-density Lipoprotein (HDL) Cholesterol: Week 12	The observed values of HDL cholesterol at week 12 are presented.	At week 12
HDL Cholesterol: Week 24	The observed values of HDL cholesterol at week 24 are presented.	At week 24
Hepcidin-25: Week 12	The observed values of hepcidin-25 at week 12 are presented.	At week 12
Hepcidin-25: Week 24	The observed values of hepcidin-25 at week 24 are presented.	At week 24
Low-density Lipoproteins (LDL) Cholesterol: Week 12	The observed values of LDL cholesterol at week 12 are presented.	At week 12
LDL Cholesterol: Week 24	The observed values of LDL cholesterol at week 24 are presented.	At week 24
Lipoprotein-a: Week 12	The observed values of lipoprotein-a at week 12 are presented.	At week 12
Lipoprotein-a: Week 24	The observed values of lipoprotein-a at week 24 are presented.	At week 24
Phosphate: Week 12	The observed values of phosphate at week 12 are presented.	At week 12
Phosphate: Week 24	The observed values of phosphate at week 24 are presented.	At week 24
Potassium: Week 12	The observed values of potassium at week 12 are presented.	At week 12
Potassium: Week 24	The observed values of potassium at week 24 are presented.	At week 24
Sodium: Week 12	The observed values of sodium at week 12 are presented.	At week 12
Sodium: Week 24	The observed values of sodium at week 24 are presented.	At week 24
Triglycerides: Week 12	The observed values of triglyceride at week 12 are presented.	At week 12
Triglycerides: Week 24	The observed values of triglycerides at week 24 are presented.	At week 24
Urea Nitrogen: Week 12	The observed values of urea nitrogen at week 12 are presented.	At week 12
Urea Nitrogen: Week 24	The observed values of urea nitrogen at week 24 are presented.	At week 24
Pre-dialysis Body Mass Index (BMI): Week 12	Pre-dialysis BMI values at week 12 are presented.	At week 12
Pre-infusion BMI: Week 11	Pre-infusion BMI values at week 11 are presented.	At week 11
Pre-dialysis Diastolic Blood Pressure: Week 12	Pre-dialysis diastolic blood pressure values at week 12 are presented.	At week 12
Pre-dialysis Diastolic Blood Pressure: Week 24	Pre-dialysis diastolic blood pressure values at week 24 are presented.	At week 24
Pre-infusion Diastolic Blood Pressure: Week 11	Pre-infusion diastolic blood pressure values at week 11 are presented.	At week 11
Pre-dialysis Heart Rate: Week 12	Pre-dialysis heart rate values at week 12 are presented.	At week 12
Pre-dialysis Heart Rate: Week 24	Pre-dialysis heart rate values at week 24 are presented.	At week 24
Pre-infusion Heart Rate: Week 11	Pre-infusion heart rate values at week 11 are presented.	At week 11
Pre-dialysis Respiration Rate: Week 12	Pre-dialysis respiration rate values at week 12 are presented.	At week 12
Pre-dialysis Respiration Rate: Week 24	Pre-dialysis respiration rate values at week 24 are presented.	At week 24
Pre-infusion Respiration Rate: Week 11	Pre-infusion respiration rate values at week 11 are presented.	At week 11
Pre-dialysis Systolic Blood Pressure: Week 12	Pre-dialysis values of systolic blood pressure at week 12 are presented.	At week 12
Pre-dialysis Systolic Blood Pressure: Week 24	Pre-dialysis values of systolic blood pressure at week 24 are presented.	At week 24
Pre-infusion Systolic Blood Pressure: Week 11	Pre-infusion systolic blood pressure values at week 11 are presented.	At week 11
Pre-dialysis Weight: Week 12	Pre-dialysis weight values at week 12 are presented.	At week 12
Pre-infusion Weight: Week 11	Pre-infusion weight values at week 11 are presented.	At week 11
Pre-dialysis Temperature: Week 12	Pre-dialysis temperature values at week 12 are presented.	At week 12
Pre-dialysis Temperature: Week 24	Pre-dialysis temperature values at week 24 are presented.	At week 24
Pre-infusion Temperature: Week 11	Pre-infusion temperature values at week 11 are presented.	At week 11
Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001	Area under the serum concentration time curve from time 0 to infinity (AUC 0-α) of COR-001 is presented.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Elimination Half-life in the Initial Phase (t 1/2,α)	Elimination half-life in the initial phase (t 1/2,α) is presented from week 0 to week 35.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Elimination Half-life in the Terminal Phase (t 1/2, z)	Elimination half-life in the terminal phase(t 1/2, z) is presented from week 0 to week 35.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Maximum Serum Concentration (Cmax)	Maximum serum concentration (Cmax) of COR-001 from week 0 to week 35 is presented.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Impact of ADAs on Pharmacokinetics	Presence of ADA was a covariate for pharmacokinetics (PK) affecting V1 (volume of distribution for the central compartment). Impact of ADAs on V1 from baseline to week 35 is presented. In the below table, result presented is the bootstrap parameter estimate of the effect of ADA on V1 for a PK model that includes data for all arms combined.	Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Pergola PE, Devalaraja M, Fishbane S, Chonchol M, Mathur VS, Smith MT, Lo L, Herzog K, Kakkar R, Davidson MH. Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2021 Jan;32(1):211-222. doi: 10.1681/ASN.2020050595. Epub 2020 Dec 3.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2016
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): December 11, 2018

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NN6018-4791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No