History of Changes for Study: NCT04166773

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

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Study Record Versions

Version	Submitted Date	Changes
1	November 15, 2019	None (earliest Version on record)
2	November 22, 2019	References and Study Status
3	December 2, 2019	Recruitment Status, Study Status, Contacts/Locations and Oversight
4	December 16, 2019	Contacts/Locations and Study Status
5	January 2, 2020	Contacts/Locations and Study Status
6	January 16, 2020	Contacts/Locations and Study Status
7	February 4, 2020	Contacts/Locations and Study Status
8	February 19, 2020	Contacts/Locations and Study Status
9	March 2, 2020	Contacts/Locations and Study Status
10	March 16, 2020	Contacts/Locations and Study Status
11	April 21, 2020	Contacts/Locations and Study Status
12	May 4, 2020	Contacts/Locations and Study Status
13	May 18, 2020	Contacts/Locations and Study Status
14	June 4, 2020	Contacts/Locations and Study Status
15	June 17, 2020	Contacts/Locations and Study Status
16	July 2, 2020	Contacts/Locations and Study Status
17	July 6, 2020	Contacts/Locations and Study Status
18	July 17, 2020	Contacts/Locations and Study Status
19	August 3, 2020	Contacts/Locations and Study Status
20	August 17, 2020	Contacts/Locations and Study Status
21	September 2, 2020	Contacts/Locations and Study Status
22	September 16, 2020	Contacts/Locations and Study Status
23	October 2, 2020	Contacts/Locations and Study Status
24	October 16, 2020	Contacts/Locations and Study Status
25	November 3, 2020	Contacts/Locations and Study Status
26	November 17, 2020	Contacts/Locations and Study Status
27	December 3, 2020	Contacts/Locations and Study Status
28	December 17, 2020	Contacts/Locations and Study Status
29	January 6, 2021	Contacts/Locations and Study Status
30	January 8, 2021	References and Study Status
31	January 18, 2021	Contacts/Locations and Study Status
32	February 4, 2021	Contacts/Locations and Study Status
33	February 17, 2021	Contacts/Locations and Study Status
34	March 3, 2021	Contacts/Locations and Study Status
35	March 18, 2021	Contacts/Locations and Study Status
36	April 6, 2021	Contacts/Locations and Study Status
37	April 16, 2021	Contacts/Locations and Study Status
38	May 4, 2021	Contacts/Locations and Study Status
39	May 18, 2021	Contacts/Locations and Study Status
40	June 8, 2021	Contacts/Locations and Study Status
41	June 17, 2021	Contacts/Locations and Study Status
42	July 6, 2021	Contacts/Locations and Study Status
43	July 15, 2021	Study Status
44	August 4, 2021	Study Status
45	August 17, 2021	Study Status and Contacts/Locations
46	September 2, 2021	Contacts/Locations and Study Status
47	September 20, 2021	Contacts/Locations and Study Status
48	October 5, 2021	Contacts/Locations and Study Status
49	October 15, 2021	Contacts/Locations and Study Status
50	November 8, 2021	Contacts/Locations and Study Status
51	November 17, 2021	Contacts/Locations and Study Status
52	December 8, 2021	Contacts/Locations and Study Status
53	December 16, 2021	Contacts/Locations and Study Status
54	January 5, 2022	Study Status and Contacts/Locations
55	January 18, 2022	Contacts/Locations and Study Status
56	February 3, 2022	Contacts/Locations and Study Status
57	February 18, 2022	Contacts/Locations and Study Status
58	March 9, 2022	Contacts/Locations and Study Status
59	March 22, 2022	Contacts/Locations and Study Status
60	April 6, 2022	Study Status and Contacts/Locations
61	April 18, 2022	Contacts/Locations and Study Status
62	May 9, 2022	Contacts/Locations and Study Status
63	May 20, 2022	Contacts/Locations and Study Status
64	June 9, 2022	Contacts/Locations and Study Status
65	June 20, 2022	Contacts/Locations and Study Status
66	July 7, 2022	Study Status and Contacts/Locations
67	July 19, 2022	Contacts/Locations and Study Status
68	August 8, 2022	Study Status
69	August 17, 2022	Contacts/Locations and Study Status
70	September 8, 2022	Contacts/Locations and Study Status
71	October 11, 2022	Contacts/Locations and Study Status
72	October 18, 2022	Contacts/Locations and Study Status
73	November 10, 2022	Contacts/Locations and Study Status
74	November 23, 2022	Contacts/Locations and Study Status
75	December 9, 2022	Contacts/Locations and Study Status
76	December 26, 2022	Contacts/Locations and Study Status
77	January 10, 2023	Contacts/Locations and Study Status
78	January 17, 2023	Recruitment Status, Contacts/Locations and Study Status
79	February 13, 2023	Study Status
80	February 22, 2023	Study Status
81	March 7, 2023	Study Status
82	April 12, 2023	Study Status
83	April 16, 2023	Study Status
84	May 12, 2023	Study Status
85	May 23, 2023	Study Status
86	June 11, 2023	Study Status
87	July 12, 2023	Study Status
88	July 28, 2023	Contacts/Locations and Study Status
89	September 6, 2023	Contacts/Locations and Study Status
90	October 5, 2023	Contacts/Locations and Study Status
91	October 19, 2023	Study Status
92	April 17, 2024	Recruitment Status, Contacts/Locations, Study Status and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	17361
Brief Title:	A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (SYNERGY-NASH)
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Secondary IDs:	I8F-MC-GPHR [Eli Lilly and Company] 2019-001550-26 [EudraCT Number]

Study Status


Record Verification:	November 15, 2019
Overall Status:	Not yet recruiting
Study Start:	November 18, 2019
Primary Completion:	March 21, 2022 [Anticipated]
Study Completion:	March 21, 2022 [Anticipated]

First Submitted:	November 15, 2019
First Submitted that Met QC Criteria:	November 15, 2019
First Posted:	November 18, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	November 15, 2019
Last Update Posted:	November 18, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Eli Lilly and Company
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description


Brief Summary:	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).
Detailed Description:

Conditions


Conditions:	Nonalcoholic Steatohepatitis
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	4
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	196 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


Primary Outcome Measures:
1.	Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology [ Time Frame: Week 52 ] Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology
Secondary Outcome Measures:
1.	Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology [ Time Frame: Week 52 ] Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology
2.	Percentage of Participants with ≥1 Point Increase in Fibrosis Stage on Liver Histology [ Time Frame: Week 52 ] Percentage of Participants with ≥1 Point Increase in Fibrosis Stage on Liver Histology
3.	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 ] Percentage of Participants that Achieve a ≥2 Point Decrease in NAS on Liver Histology, with ≥1 Point Reduction in at Least 2 NAS Components
4.	Mean Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: Baseline, Week 52 ] Mean Absolute Change from Baseline in Liver Fat Content by MRI-PDFF
5.	Mean Change from Baseline in Body Weight [ Time Frame: Baseline, Week 52 ] Mean Change from Baseline in Body Weight

Eligibility


Minimum Age:	18 Years
Maximum Age:	80 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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)

Contacts/Locations


Central Contact Person:	There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or Telephone: 1-317-615-4559 Email: clinicaltrials.gov@lilly.com
Study Officials:	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Locations:	United States, Alabama
	University of Alabama - The Clinical Research Enterprise Birmingham, Alabama, United States, 35233 Contact:Contact: 205-975-5683 Contact:Principal Investigator: Omar Massoud
	United States, California
	Fresno Clinical Research Center Fresno, California, United States, 93720 Contact:Contact: 559-297-2259 Contact:Principal Investigator: Muhammad Sheikh
	National Research Institute Huntington Park, California, United States, 90255 Contact:Contact: 323-588-1968 Contact:Principal Investigator: Stanley Hsia
	NAFLD Research Center, UCSD Altman Clinical and Translational Research Institute (ACTRI) La Jolla, California, United States, 92037 Contact:Contact: 858-246-2201 Contact:Principal Investigator: Rohit Loomba
	National Research Institute Los Angeles, California, United States, 90057 Contact:Contact: 213-413-2500 Contact:Principal Investigator: Juan P Frias
	Catalina Research Institute, LLC Montclair, California, United States, 91763 Contact:Contact: 909-590-8409 Contact:Principal Investigator: Rizwana H. Mohseni
	Diabetes Medical Center of California Northridge, California, United States, 91325 Contact:Contact: 818-368-4212 Contact:Principal Investigator: Gholamreza Bonabi
	National Research Institute Panorama City, California, United States, 91402 Contact:Contact: 818-532-6880 Contact:Principal Investigator: Robert A Jenders
	Alliance Clinical Research, LLC Poway, California, United States, 90264 Contact:Contact: 949-973-3704 Contact:Principal Investigator: Kevin Merkes
	Inland Empire Liver Foundation Rialto, California, United States, 92377 Contact:Contact: 909-883-2999 Contact:Principal Investigator: Zeid Kayali
	United States, Florida
	Excel Medical Clinical Trials, LLC Boca Raton, Florida, United States, 33434 Contact:Contact: 561-488-5535 Contact:Principal Investigator: Seth Baum
	Clinical Research of South Florida Coral Gables, Florida, United States, 33134 Contact:Contact: 305-445-5637 Contact:Principal Investigator: Jeffrey B Rosen
	University of Florida- Division of Endocrinology,Diabetes and Metabolism Gainesville, Florida, United States, 32610 Contact:Contact: 352-273-7236 Contact:Principal Investigator: Kenneth Cusi
	Research Centers of America, LLC-Hollywood Hollywood, Florida, United States, 33024 Contact:Contact: 954-919-7809 Contact:Principal Investigator: HOWARD SCHWARTZ
	East Coast Clinical Research Jacksonville, Florida, United States, 32204 Contact:Contact: 9043842240 ext 4280 Contact:Principal Investigator: James S Magee
	Meridien Research Maitland, Florida, United States, 32751 Contact:Contact: 407-644-1165 Contact:Principal Investigator: Eva Maria Heurich
	Clinical Pharmacology of Miami Miami, Florida, United States, 33014 Contact:Contact: 305-817-2900 Contact:Principal Investigator: Ernesto Fuentes
	Endoscopic Research Inc Orlando, Florida, United States, 32803 Contact:Contact: 407-241-3229 Contact:Principal Investigator: Henry Levine
	United States, Illinois
	Northwestern Feinberg School of Medicine Chicago, Illinois, United States, 60611 Contact:Contact: 312-695-5878 Contact:Principal Investigator: Mary Rinella
	United States, Indiana
	Indiana Universtiy Division of Gastroenterology and Hepatology Indianapolis, Indiana, United States, 46202 Contact:Contact: 317-278-1652 Contact:Principal Investigator: Raj K Vuppalanchi
	United States, Iowa
	Iowa Diabetes Research West Des Moines, Iowa, United States, 50265 Contact:Contact: 515-329-6800 Contact:Principal Investigator: Anuj Bhargava
	United States, Kansas
	Cotton O'Neil Diabetes and Endocrinology Center Topeka, Kansas, United States, 66606 Contact:Contact: 785-368-0482 Contact:Principal Investigator: Susan R Brian
	Heartland Research Associates Wichita, Kansas, United States, 67207 Contact:Contact: 316-689-6629 Contact:Principal Investigator: Thomas C. Klein
	Heartland Research Associates Wichita, Kansas, United States, 67207 Contact:Contact: 316-283-0828 Contact:Principal Investigator: Richard M Glover
	United States, Louisiana
	Tandem Clinical Research,LLC Marrero, Louisiana, United States, 70072 Contact:Contact: 504-934-8424 Contact:Principal Investigator: Gary Reiss
	United States, Mississippi
	GEN1 Research - NDORI Biloxi, Mississippi, United States, 39532 Contact:Contact: 512-717-8610 Contact:Principal Investigator: Mark Borchelt
	Southern Therapy and Advanced Research (STAR) LLC Jackson, Mississippi, United States, 39216 Contact:Contact: 769-251-5674 Contact:Principal Investigator: Brian Borg
	United States, New York
	Montefiore Medical Center Bronx, New York, United States, 10467-2490 Contact:Contact: 718-920-4664 Contact:Principal Investigator: Samuel Sigal
	University at Buffalo-Clinical and Translational Research Center Buffalo, New York, United States, 14203-1070 Contact:Contact: 716-888-4737 Contact:Principal Investigator: Andrew Talal
	NYU Langone Medical Center New York, New York, United States, 10016 Contact:Contact: 646-501-4927 Contact:Principal Investigator: Ira Jacobson
	Mount Sinai School of Medicine New York, New York, United States, 10029-6574 Contact:Contact: 212-241-7270 Contact:Principal Investigator: Amon Asgharpour
	United States, North Carolina
	Diabetes & Endocrinology Consultants PC Morehead City, North Carolina, United States, 28557 Contact:Contact: 2522225700 x25 Contact:Principal Investigator: Kathryn Jean Lucas
	United States, Pennsylvania
	Geisinger Clinic- Danville Danville, Pennsylvania, United States, 17822 Contact:Contact: 570-214-2215 Contact:Principal Investigator: Christopher Still
	United States, Tennessee
	ClinSearch Chattanooga, Tennessee, United States, 37421 Contact:Contact: 423-698-4584 Contact:Principal Investigator: Mark McKenzie
	United States, Texas
	Texas Diabetes and Endocrinology Austin, Texas, United States, 78749 Contact:Contact: 512-458-8400 Contact:Principal Investigator: Tira Chaicha-Brom
	Dallas Diabetes Endocrine Center Dallas, Texas, United States, 75230 Contact:Contact: 972-566-8631 Contact:Principal Investigator: Pablo Mora
	Liver Center of Texas, PLLC Dallas, Texas, United States, 75234-7858 Contact:Contact: 469-317-7703 Contact:Principal Investigator: Abdullah Mubarak
	UT Health San Antonio Texas Diabetes Institute San Antonio, Texas, United States, 78207 Contact:Principal Investigator: Ralph DeFronzo
	The Texas Liver Institute San Antonio, Texas, United States, 78215 Contact:Contact: 210-253-3426 Contact:Principal Investigator: Eric Lawitz
	Endeavor Clinical Trials San Antonio, Texas, United States, 78229 Contact:Contact: 210-949-0807 Contact:Principal Investigator: Hernan A Salazar
	United States, Virginia
	National Clinical Research - Richmond Richmond, Virginia, United States, 23294 Contact:Contact: 804-672-2295 Contact:Principal Investigator: JOHN W. SCOTT
	Virginia Commonwealth University Medical Center Gastroenterology Hepatology Richmond, Virginia, United States, 23298 Contact:Contact: 804-920-0717 Contact:Principal Investigator: Mohammad S Siddiqui
	United States, Washington
	Harborview Medical Center/University of Washington Seattle, Washington, United States, 98104 Contact:Contact: 206-744-7064 Contact:Principal Investigator: Charles Landis
	Belgium
	UZ Brussel - Gastro-enterology Brussel, Belgium, 1090 Contact:Contact: 003224777760 Contact:Principal Investigator: Hendrik Reynaert
	Universitair Ziekenhuis Antwerpen Edegem, Belgium, 2650 Contact:Contact: 32382134780 Contact:Principal Investigator: Christophe De Block
	Belgium, East Flanders
	UZ Gent Hospital Gent, East Flanders, Belgium, 9000 Contact:Contact: 003293322374 Contact:Principal Investigator: Anja Geerts
	Belgium, Flemish Brabant
	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven, Flemish Brabant, Belgium, 3000 Contact:Contact: 003216346994 Contact:Principal Investigator: Ann Mertens
	Belgium, West Flanders
	AZ Delta Roeselare, West Flanders, Belgium, 8800 Contact:Contact: +32051237534 Contact:Principal Investigator: Charlotte DeVloo
	France
	CHRU de Limoges Hopital Dupuytren Limoges CEDEX, France, 87042 Contact:Contact: 33 (0)5 55 05 66 41 Contact:Principal Investigator: Véronique LOUSTAUD-RATTI
	Hôpital de la Pitié-Salpêtrière Paris, France, 75013 Contact:Contact: 0331 84 82 77 62 Contact:Principal Investigator: Vlad Ratziu
	Chu Haut-Leveque Pessac, France, 33604 Contact:Contact: +33557656995 Contact:Principal Investigator: Victor De Ledinghen
	Centre Hospitalier Lyon Sud Pierre Benite Cedex, France, 69495 Contact:Contact: 033472666401 Contact:Principal Investigator: Cyrielle Caussy
	France, Cedex 12
	Hôpital Saint Antoine - Service d'Hépato-gastro-entérologie Paris, Cedex 12, France, 75012 Contact:Contact: +33149283398 Contact:Principal Investigator: Marie Lequoy
	France, Cedex 9
	CHU Angers Angers, Cedex 9, France, 49933 Contact:Contact: +33241353410 Contact:Principal Investigator: Jerome Boursier
	Israel
	Rambam Medical Center Haifa, Israel, 3109601 Contact:Contact: 97247772956 Contact:Principal Investigator: Ella Veitsman
	Hadassah Medical Center Jerusalem, Israel, 91120 Contact:Contact: +97226777337 Contact:Principal Investigator: Rifaat Safadi
	Sheba Medical Center Ramat Gan, Israel, 5266202 Contact:Contact: 97235307180 Contact:Principal Investigator: Ziv Ben-Ari
	Italy
	Ospedali Riuniti Foggia Foggia, Italy, 71100 Contact:Contact: 390881741587 Contact:Principal Investigator: Gaetano Serviddio
	Ospedale Santa Maria Goretti Latina, Italy, 04100 Contact:Contact: 3907736553805 Contact:Principal Investigator: Frida Leonetti
	Ospedale Maggiore di Milano Milano, Italy, 20122 Contact:Contact: 390250320610 Contact:Principal Investigator: Emanuela Orsi
	A.O. Universitaria Policlinico P. Giaccone Palermo, Italy, 90127 Contact:Contact: 393288265282 Contact:Principal Investigator: Salvatore Petta
	Azienda Ospedaliera Citta della Salute della Scienza Torino Torino, Italy, 10126 Contact:Contact: 39011633541 Contact:Principal Investigator: Elisabetta Bugianesi
	Japan
	Gifu Municipal Hospital Gifu, Japan, 500-8513 Contact:Contact: 81120023812 Contact:Principal Investigator: Hideki Hayashi
	Saga Medical School Hospital Saga, Japan, 849-8501 Contact:Contact: 81120023812 Contact:Principal Investigator: Yuichiro Eguchi
	Japan, Aichi-ken
	Aichi Medical University Hospital Nagakute-shi, Aichi-ken, Japan, 480-1195 Contact:Contact: 81120023812 Contact:Principal Investigator: Yoshio Sumida
	Japan, Kanagawa
	Yokohama City University Hospital Yokohama, Kanagawa, Japan, 236-0004 Contact:Contact: 81120023812 Contact:Principal Investigator: Kento Imajo
	Japan, Osaka
	Saiseikai Suita Hospital Suita-shi, Osaka, Japan, 5640013 Contact:Contact: 81120023812 Contact:Principal Investigator: Toshihide Shima
	Japan, Shimane
	Shimane University Hospital Izumo, Shimane, Japan, 693-8501 Contact:Contact: 81120023812 Contact:Principal Investigator: Hiroshi Tobita
	Spain
	Hospital Universitario Ramon y Cajal Madrid, Spain, 28034 Contact:Contact: 34913368592 Contact:Principal Investigator: Agustin Albillos Martinez
	Hospital Universitario Virgen del Rocio Sevilla, Spain, 41013 Contact:Contact: 955012065 Contact:Principal Investigator: Manuel Romero Gomez
	Spain, Cantabria
	Hospital Universitario Marques De Valdecilla Santander, Cantabria, Spain, 39008 Contact:Contact: 34942202680 Contact:Principal Investigator: Javier Crespo Garcia
	Spain, Madrid
	Hospital Puerta De Hierro Majadahonda, Madrid, Spain, 28222 Contact:Contact: 0034911917334 Contact:Principal Investigator: Jose Luis Calleja
	United Kingdom
	Aintree Hospitals Liverpool, United Kingdom, L9 7AL Contact:Contact: 01515292814 Contact:Principal Investigator: Nick Stern
	St Thomas's Hospital London, United Kingdom, SE1 7EH Contact:Contact: 07855274704 Contact:Principal Investigator: Jude Oben
	St. George'S Healthcare Nhs Trust London, United Kingdom, SW17 0RE Contact:Contact: 0208 266 6866 Contact:Principal Investigator: Daniel Forton
	Imperial College London and Imperial College Healthcare NHS Trust London, United Kingdom, W2 1NY Contact:Contact: 02033126666 Contact:Principal Investigator: Pinelopi Manousou
	Southampton General Hospital Southampton, United Kingdom, SO16 6YD Contact:Contact: 023 8120 4862 Contact:Principal Investigator: Janisha Patel
	United Kingdom, London
	Royal London Hospital Whitechapel, London, United Kingdom, E3 4NG Contact:Contact: +44 20 3594 6773 Contact:Principal Investigator: William Alazawi
	United Kingdom, Nottinghamshire
	Queen's MedicaL Centre/University of Nottingham Nottingham, Nottinghamshire, United Kingdom, NG7 2UH Contact:Contact: 441159249924 Contact:Principal Investigator: Stephen Ryder
	United Kingdom, Oxfordshire
	John Radcliffe Hospital Headington, Oxfordshire, United Kingdom, OX3 9DU Contact:Contact: 01865228756 Contact:Principal Investigator: Jeremy Cobbold
	United Kingdom, West Midlands
	Queen Elizabeth Hospital Birmingham, West Midlands, United Kingdom, B15 2TH Contact:Contact: 0121 371 4673 Contact:Principal Investigator: Matthew Armstrong

IPDSharing


Plan to Share IPD:	Yes Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
	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.
	Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
	URL: http://vivli.org/

References


Citations:
Links:
Available IPD/Information: