A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (SYNERGY-NASH)

January 22, 2025 updated by: Eli Lilly and Company

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).

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.
190

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

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Antwerp University Hospital
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1090
        • UZ Brussel
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ Delta vzw
  • France
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 75013
        • Pitie Salpetriere University Hospital
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • CHU Bordeaux Haut-Leveque
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87042
        • Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Centre Hospitalier Universitaire d'Angers
    • Rhône
      • Pierre-Bénite, Rhône, France, 69494 Cédex
        • Centre Hospitalier Lyon sud
    • Rhône-Alpes
      • Vénissieux, Rhône-Alpes, France, 69200
        • Groupe Hospitalier Mutualiste Les Portes du Sud
  • Israel
      • Haifa, Israel, 3436212
        • Carmel Hospital
    • HaMerkaz
      • Ramat Gan, HaMerkaz, Israel, 5265601
        • Sheba Medical Center
    • HaTsafon
      • Haifa, HaTsafon, Israel, 3109601
        • Rambam Health Care Campus
      • Nahariya, HaTsafon, Israel, 2210001
        • Galilee Medical Center
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9112001
        • Hadassah Medical Center
      • Jerusalem, Yerushalayim, Israel, 9778419
        • Shaare Zedek Medical Center
  • Italy
      • Foggia, Italy, 71100
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
      • Latina, Italy, 04100
        • Ospedale Santa Maria Goretti
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Torino, Italy, 10126
        • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • A.O.U. Policlinico Paolo Giaccone
  • Japan
      • Fukui, Japan, 918-8503
        • Fukuiken Saiseikai Hospital
      • Gifu, Japan, 500-8323
        • Gifu Municipal Hospital
      • Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital,Kyoto Prefectural University of Medicine
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 062-8618
        • JCHO Hokkaido Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital
      • Yokohama, Kanagawa, Japan, 2458575
        • National Hospital Organization Yokohama Medical Center
    • Nara-Ken
      • Nara-Shi, Nara-Ken, Japan, 630-8305
        • JADECOM Nara City Hospital
    • Osaka
      • Higashi-cho, Hirakata-city, Osaka, Japan, 573-0153
        • Hirakata kohsai Hospital
      • Suita, Osaka, Japan, 564-0013
        • Osaka Saiseikai Suita hospital
    • Shimane
      • Izumo, Shimane, Japan, 693-0021
        • Shimane University Hospital
    • Tokyo
      • Bunkyō, Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Medical Hospital
  • Mexico
      • Cuauhtémoc, Mexico, 6700
        • Centro de Investigación y Gastroenterología
    • Distrito Federal
      • Cuautitlan Izcalli, Distrito Federal, Mexico, 54769
        • Phylasis Clinicas Research
      • Mexico City, Distrito Federal, Mexico, 3310
        • Grupo Medico Camino Sc
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64988
        • Christus Muguerza Hospital Sur
  • Poland
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-672
        • Synexus Polska Sp. z o.o. Oddzial w Warszawie
    • Łódzkie
      • Lodz, Łódzkie, Poland, 90-127
        • Synexus Polska Oddział w Lodzi
  • Spain
      • Alicante, Spain, 3004
        • Instituto de Ciencias Médicas
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain, 41003
        • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
    • Balears [Baleares]
      • Palma de Mallorca, Balears [Baleares], Spain, 7014
        • Clínica Juaneda
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Hospital Universitario Ramón y Cajal
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Synexus Midlands Clinical Research Centre
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital NHS Foundation Trust
      • Manchester, United Kingdom, M15 6SX
        • Synexus Manchester Clinical Research Centre
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital Birmingham
      • Hexham, England, United Kingdom, NE46 1QJ
        • Synexus North East Clinical Research Centre
      • London, England, United Kingdom, E1 1BB
        • Royal London Hospital
      • London, England, United Kingdom, SW17 0QT
        • St. George's Hospital
    • Lancashire
      • Chorley, Lancashire, United Kingdom, PR7 7NA
        • Synexus Clinical Research Centre - Lancashire
    • London, City Of
      • London, London, City Of, United Kingdom, SE5 9RL
        • King's College Hospital
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Queen's Medical Centre, Nottingham University Hospitals
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
    • Stockton-on-Tees
      • Stockton on Tees, Stockton-on-Tees, United Kingdom, TS19 8PE
        • Synexus North Teesside Clinical Research Centre
    • Westminster
      • London, Westminster, United Kingdom, W2 1NY
        • Imperial College London - St Mary's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama-The Kirklin Clinic
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Synexus Clinical Research US, Inc.
    • California
      • Fresno, California, United States, 93720
        • Fresno Clinical Research Center
      • Huntington Park, California, United States, 90255
        • National Research Institute - Huntington Park
      • La Jolla, California, United States, 92037
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Northridge, California, United States, 91325
        • Diabetes Medical Center Of California
      • Panorama City, California, United States, 91402
        • Velocity Clinical Research, Panorama City
      • Rialto, California, United States, 92377
        • Inland Empire Clinical Trials, LLC
      • Santa Ana, California, United States, 92704
        • Velocity Clinical Research, Santa Ana
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispecialty Research, LLC
      • Hollywood, Florida, United States, 33024
        • Research Centers of America ( Hollywood )
      • Jacksonville, Florida, United States, 32204
        • East Coast Institute for Research, LLC
      • Kissimmee, Florida, United States, 34741
        • IHS Health Research
      • Maitland, Florida, United States, 32751
        • Accel Research Sites - Maitland Clinical Research Unit
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami
      • Orlando, Florida, United States, 32803
        • The Center for Digestive Health
      • Orlando, Florida, United States, 32806
        • Synexus Clinical Research US, Inc.
      • The Villages, Florida, United States, 32162
        • Synexus Clinical Research US, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Synexus Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Hospital
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
    • Mississippi
      • Biloxi, Mississippi, United States, 39532
        • The National Diabetes & Obesity Research Institute
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research (STAR) LLC
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14203
        • Buffalo Clinical and Translational Research Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • NYU Langone Health
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Diabetes & Endocrinology Consultants, PC
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch, LLC
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Dallas, Texas, United States, 75231
        • Radiant Research - Dallas North
      • Dallas, Texas, United States, 75234-7858
        • Liver Center of Texas, PLLC
      • Denison, Texas, United States, 75020
        • Texoma Medical Center
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A.
      • San Antonio, Texas, United States, 78229
        • Synexus Clinical Research US, Inc.
      • San Antonio, Texas, United States, 78215
        • American Research Corporation at Texas Liver Institute
      • San Antonio, Texas, United States, 78240
        • Endeavor Clinical Trials
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University (VCU) Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center/University of Washington

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • Participants must have a body mass index (BMI) ≥27 kilograms per square meter (kg/m²) and ≤50 kg/m² with stable body weight for at least 3 months

  • Participants with or without type 2 diabetes mellitus (T2DM)

    • If with T2DM, hemoglobin A1c (HbA1c) ≤9.5%
  • Participants must be willing to undergo baseline and endpoint liver biopsies
  • Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by liver biopsy
  • Participants must not have known or suspected alcohol abuse (>14 units/week for women and >21 units/week for men) or active substance abuse
  • Participants must not have evidence of cirrhosis or other forms of liver disease
  • Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 6 months
  • Participants must not have active cancer within the last 5 years
  • Participants must not have uncontrolled high blood pressure
  • Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <30 milliters/minute/1.73m²; for participants on metformin, eGFR <45 mL/min/1.73m²
  • Participants must not have a diagnosis of type 1 diabetes
  • Participants must not have a history of pancreatitis (acute or chronic)
  • Participants must not have calcitonin ≥35 nanograms per liter
  • Participant must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
  • Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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.
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Placebo Comparator: Placebo
Placebo administered SC once a week.
Drug: Placebo
Administered SC

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
Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology
Time Frame: Week 52
NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52.
Week 52

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
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology
Time Frame: Week 52
NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of NASH (defined as no increase in the NAS score).
Week 52
Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology
Time Frame: Week 52
Participants were evaluated with the NASH CRN scoring system with ≥1 stage increase in fibrosis.
Week 52
Percentage of Participants That Achieve a ≥2 Point Decrease in NAFLD (Non-alcoholic Fatty Liver Disease) Activity Score (NAS) on Liver Histology, With ≥1 Point Reduction in at Least 2 NAS Components
Time Frame: Week 52
Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in at least 2 NAS components (lobular inflammation, hepatocellular ballooning or steatosis). The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8, with the higher score indicating more aggressive disease.
Week 52
Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time Frame: Baseline to Week 52
MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage (%) and ranges from 0 to 100% with higher values representing higher liver fat level. Least square (LS) mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Diabetes Flag (DIABFL) + REGION1 + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline to Week 52
Mean Change From Baseline in Body Weight
Time Frame: Baseline to Week 52
Change in body weight at the end of 52 weeks measured in kilogram (kg) using a calibrated scale. LS mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + DIABFL + REGION1 + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline to Week 52

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.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

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.
November 19, 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.
December 11, 2023

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.
January 10, 2024

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).
November 15, 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.
November 15, 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.
November 18, 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.
March 25, 2025

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.
January 22, 2025

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.
January 1, 2025

More Information

Terms related to this study

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.
  • 17361
  • I8F-MC-GPHR (Other Identifier: Eli Lilly and Company)
  • 2019-001550-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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.

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