A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

April 18, 2022 updated by: Pfizer

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED DAILY FOR 16 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE AND TYPE 2 DIABETES MELLITUS ON METFORMIN

This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1W4R4
        • Centre de Recherche Saint-Louis
      • Quebec, Canada, G1J 0H4
        • IRM Quebec
      • Quebec, Canada, G2J 0C4
        • Alpha Recherche Clinique Lebourgneuf
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 5G4
        • Discovery Clinical Services Ltd.
      • Victoria, British Columbia, Canada, V8Z0B9
        • West Coast Medical Imaging
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health Authority QE II Health Sciences Centre
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health Authority QE II Health Sciences Centre
      • Halifax, Nova Scotia, Canada, B3K 4N1
        • Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Limited
      • London, Ontario, Canada, N6A 5B7
        • The Western Centre for Functional and Metabolic Mapping
      • Mississauga, Ontario, Canada, L5R 3K7
        • Oxford Medical Imaging
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group, Inc.
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Chicoutimi, Quebec, Canada, G7H 4J1
        • Resonance Magnetique du Saguenay-Lac-Saint-Jean
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H2L 4E9
        • Clinique de médecine Urbaine du Quartier Latin
      • Montreal, Quebec, Canada, H4A 3J1
        • MRI TTT Philips Radiation Oncology
      • Montreal, Quebec, Canada, H5B1B2
        • Radiologie Varad
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85295
        • Horizon Clinical Research Associates, PLLC
      • Tempe, Arizona, United States, 85207
        • Clinical Research Consortium an AMR company
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials LLC-Clinical Research
      • Canoga Park, California, United States, 91303
        • HOPE Clinical Research
      • Chula Vista, California, United States, 91911
        • San Diego Imaging SDI
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Coronado, California, United States, 92118
        • Sharp Coronado Hospital
      • Harbor City, California, United States, 90710
        • Holy Trinity Medical Clinic
      • Harbor City, California, United States, 90710
        • Innovative Clinical Research, Inc.
      • Inglewood, California, United States, 90301
        • ICM Medical Group
      • La Mesa, California, United States, 91942
        • eStudySite
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Northridge, California, United States, 91328
        • Renaissance Imaging Medical Associates
      • Pasadena, California, United States, 91105
        • Huntington Medical Research Institute
      • Rialto, California, United States, 92377
        • Inland Empire Clinical Trials, LLC
      • Sacramento, California, United States, 95825
        • Diagnostic Radiological Imaging Sacramento
      • San Diego, California, United States, 92114
        • Precision Research Institute
      • San Diego, California, United States, 92123-2731
        • Sharp and Children's MRI Center, LLC
      • San Diego, California, United States, 92123
        • Sharp & Children's MRI Center, LLC
      • Santa Ana, California, United States, 92705
        • West Coast Radiology
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Tarzana, California, United States, 91356
        • Liberty Pacific Advanced Imaging
      • Thousand Oaks, California, United States, 91360
        • Advanced Gastroenterology
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Incorporated
    • Florida
      • Atlantis, Florida, United States, 33461
        • Independant Imaging
      • Daytona Beach, Florida, United States, 32117
        • Twin Lakes Imaging
      • Doral, Florida, United States, 33122
        • Life Radiology
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical LLC
      • Jacksonville, Florida, United States, 32256
        • Borland Groover
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc.
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33145
        • Stand Up MRI of Miami
      • Miami, Florida, United States, 33015
        • Health Care Family Rehab and Research Center
      • Miami, Florida, United States, 33183
        • International Research Associates
      • Miami, Florida, United States, 33126
        • Clinical Research of Miami
      • Miami, Florida, United States, 33137
        • Unique Imaging
      • Miami, Florida, United States, 33144
        • Y & L Advance Health Care, Inc D/B/A Elite Clinical Research
      • Miami, Florida, United States, 33173
        • Vital Imaging Center
      • Miami, Florida, United States, 33173
        • Vital Imaging
      • Miami, Florida, United States, 33180
        • Unique Imaging
      • Miami Lakes, Florida, United States, 33014
        • Panax Clinical Research
      • Palm Harbor, Florida, United States, 34684
        • Advanced Gastroenterology Associates, LLC
      • Palm Harbor, Florida, United States, 34685
        • Rose Radiology
      • Palm Springs, Florida, United States, 33406
        • Castillo & Torres MD PA
      • Palm Springs, Florida, United States, 33406
        • Ctmd Research Inc
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • South Miami, Florida, United States, 33143
        • Qps-Mra, Llc
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Associates , LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Alliance Multispecialty Research, LLC
    • Michigan
      • Flint, Michigan, United States, 48504
        • AA MRC
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68198
        • Nebraska Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
      • Las Vegas, Nevada, United States, 89119
        • Alliance for Multispecialty, LLC
      • Las Vegas, Nevada, United States, 89128
        • Desert Radiology
      • Las Vegas, Nevada, United States, 89128
        • Pueblo Imaging
    • New York
      • Garden City, New York, United States, 11530
        • Northwell Imaging of Garden City
      • Manhasset, New York, United States, 11030
        • Northwell Health - Center for Liver Diseases and Transplantation
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston Salem
      • Winston-Salem, North Carolina, United States, 27103
        • Gastroenterology Associates of the Piedmont, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45227
        • ProScan
      • Marion, Ohio, United States, 43302
        • RAS Health
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes and Endocrine Research Center
      • Dallas, Texas, United States, 75231
        • Southwest Diagnostics Imaging Center
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development
      • Houston, Texas, United States, 77079
        • Endocrine Ips, Pllc
      • Houston, Texas, United States, 77024
        • Primecare Medical Group
      • Houston, Texas, United States, 77079
        • The Endocrine Center
      • Houston, Texas, United States, 77098
        • Houston Medical Imaging
      • Live Oak, Texas, United States, 78233
        • South Texas Radiology Imaging Centers
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78233
        • STRIC Northeast Imaging Center
      • Schertz, Texas, United States, 78154
        • Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC)
    • Virginia
      • Richmond, Virginia, United States, 23236
        • Clinical Research Partners, LLC
      • Richmond, Virginia, United States, 23236
        • Virginia Endoscopy Group
      • Richmond, Virginia, United States, 23298
        • VCU Gateway Building Basement
      • Salem, Virginia, United States, 24153
        • Salem VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center Investigational Drug Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males, or females of nonchildbearing potential
  • 18 to 70 years of age
  • Type 2 Diabetes Mellitus
  • Liver fat >/=8% by MRI-PDFF
  • On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Exclusion Criteria:

  • History of other liver disease
  • Unable to have an MRI performed
  • Significant weight loss in the previous month and/or participant in current weight loss program
  • History of diabetic complications with end-organ damage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Palacebo
Drug: Placebo
Placebo
EXPERIMENTAL: Low Dose
150 mg
Drug: PF-06835919
150 mg once daily
Drug: PF-06835919
300 mg once daily
EXPERIMENTAL: High Dose
300 mg
Drug: PF-06835919
150 mg once daily
Drug: PF-06835919
300 mg once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Whole Liver Fat at Week 16
Time Frame: Baseline, Week 16.
Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).
Baseline, Week 16.
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16
Time Frame: Baseline, Week 16.
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Baseline, Week 16.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 21 weeks.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event. An AE was considered TEAE if the event occurred during the on-treatment period. The causality of AEs were assessed by the investigator using clinical judgement. A severe AE was an event that prevents normal everyday activities.
Up to 21 weeks.
Number of Participants With Hypoglycemia TEAEs
Time Frame: Up to 21 weeks.
Hypoglycemic AEs were routinely monitored during participation in the study. Hypoglycemic AE was defined as 1 of the following: 1. Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemic AE but a plasma glucose value of <70 milligram per deciliter (mg/dL) using glucometer; 2. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemic AEs were accompanied with a glucose value of <70 mg/dL using glucometer and the clinical picture included prompt resolution with food intake, subcutaneous glucagon or intravenous (IV) glucose; 3. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemic AEs were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration of <70 mg/dL, and the clinical picture included prompt resolution with food intake, subcutaneous glucagon, or IV glucose.
Up to 21 weeks.
Cumulative Number of Participants With Clinical Laboratory Abnormalities
Time Frame: Up to 21 weeks.
Clinical laboratory tests included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy). The abnormality criteria were standard sponsor reporting criteria.
Up to 21 weeks.
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
Time Frame: Up to 21 weeks.
Vital signs data meeting the following criteria were reported: sitting diastolic blood pressure (DBP) <50 mmHg or >= 20 mmHg increase or >= 20 mmHg decrease, sitting systolic blood pressure (SBP) blood pressure <90 mmHg or >=30 mmHg increase or >=30 mmHg decrease.
Up to 21 weeks.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
Time Frame: Up to 21 weeks.
ECG data meeting the following criteria were reported: PR interval value >=300 msec, QRS interval percent change >= 50%, QTcF interval value >450 msec and <=480 msec, or change >30 msec and <=60 msec, or change >60 msec.
Up to 21 weeks.
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Time Frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Blood samples were collected to ensure sufficient serum for the analysis of hs-CRP.
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in Fasting Insulin Over 16 Weeks
Time Frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
A sufficient amount of blood was collected for the analysis of plasma insulin. The unit of insulin is milli-international units per liter (mIU/L).
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in Fasting Glucose Over 16 Weeks
Time Frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
A sufficient amount of blood was collected for the analysis of plasma glucose.
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
Time Frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
HOMA-IR values were derived from fasting plasma insulin and glucose values. Greater reduction from baseline in HOMA-IR scale values shows greater effects on glycemic metabolism.
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
Time Frame: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
ALT was assessed as one of the clinical laboratory chemistry tests.
From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.
Change From Baseline in HbA1c at All Timepoints Other Than Week 16
Time Frame: From Baseline to Week 2, Week, 4, Week 8, and Week 12.
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
From Baseline to Week 2, Week, 4, Week 8, and Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1061011
  • DOSE RESPONSE IN PATIENTS (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings