A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes (SURPASS-2)

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Tirzepatide; Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 1879
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina, C1204AAD
    • Instituto Centenario
  • Cordoba, Argentina, X5008HHW
    • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
  • Ar-b
    • Caba, Ar-b, Argentina, C1425DES
      • CEDIC
    • Ciudad Autonoma de Buenos Aire, Ar-b, Argentina, C1119ACN
      • CIPREC
  • Ar-c
    • Buenos Aires, Ar-c, Argentina, C1179AAB
      • Investigaciones Medicas IMOBA SRL
    • C.a.b.a., Ar-c, Argentina, C1205AAO
      • CEMEDIAB
  • Ar-g
    • Santiago del Estero, Ar-g, Argentina, 4200
      • Sanatorio Norte
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1120AAC
      • Centro Medico Viamonte
    • Caba, Buenos Aires, Argentina, C1056ABJ
      • Centro de Investigaciones Metabólicas (CINME)
    • Caba, Buenos Aires, Argentina, C1425AGC
      • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
    • Ciudad Autonoma De Buenos Air, Buenos Aires, Argentina, C1128AAF
      • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
  • Mendoza
    • Godoy Cruz, Mendoza, Argentina, M5501ARP
      • CIPADI
  • Provincia De Buenos Aires
    • Mar del Plata, Provincia De Buenos Aires, Argentina, (B7600FZN)
      • Instituto de Investigaciones Clinicas Mar del Plata
• Australia
  • Woodville South, Australia, 5011
    • Adelaide Medical Solutions
  • Au-nsw
    • Blacktown, Au-nsw, Australia, 2148
      • Paratus Clinical Research Western Sydney
    • Campbelltown, Au-nsw, Australia, 2560
      • Campbelltown Medical & Dental Centre
    • Kanwal, Au-nsw, Australia, 2259
      • Paratus Clinical Research Central Coast
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
  • Queensland
    • Bundaberg, Queensland, Australia, 4670
      • GenesisCare - Bundaberg
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Womens Hospital
    • Milton, Queensland, Australia, 4064
      • Core Research Group
    • Taringa, Queensland, Australia, 4068
      • Austrials
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Clinical Research Unit
    • Geelong, Victoria, Australia, 3220
      • Barwon Health - The Geelong Hospital
  • Western Australia
    • Joondalup, Western Australia, Australia, 6027
      • GenesisCare - Wexford Medical Centre WA
    • Murdoch, Western Australia, Australia, 6150
      • GenesisCare - Wexford Medical Centre WA
• Brazil
  • São Paulo, Brazil, 05016-090
    • Dr. Consulta Clínica Médica LTDA
  • Br-es
    • Vitória, Br-es, Brazil, 29055450
      • CEDOES
  • Br-sp
    • São José dos Campos, Br-sp, Brazil, 12243-280
      • ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
    • São Paulo, Br-sp, Brazil, 01228-000
      • CPQuali Pesquisa Clínica
    • São Paulo, Br-sp, Brazil, 04266-010
      • CEPIC - Centro Paulista de Investigacao Clinica
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
      • Centro de Pesquisas em Diabetes
  • SP
    • São Paulo, SP, Brazil, 01228-200
      • CPCLIN
• Canada
  • Ca-on
    • London, Ca-on, Canada, N5W 6A2
      • Milestone Research Inc.
    • Sarnia, Ca-on, Canada, N7T 4X3
      • Bluewater Clinical Research Group Inc.
    • Toronto, Ca-on, Canada, M9V 4B4
      • Dr. Anil K. Gupta Medicine Professional Corporation
  • Ca-qc
    • Lévis, Ca-qc, Canada, G6W 0M5
      • Manna Research
  • Ontario
    • Burlington, Ontario, Canada, L7M 4Y1
      • Manna Research - Burlington North
    • Nepean, Ontario, Canada, K2J 4A7
      • Manna Research - Burlington North
    • Stoney Creek, Ontario, Canada, L8J 3W2
      • Manna Research - Burlington North
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research - Burlington North
• Israel
  • Sakhnin, Israel, 3081000
    • Clalit Health Services - Sakhnin Community Clinic
  • Tel Aviv Jaffa, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center
    • Raanana, HaMerkaz, Israel, 43405
      • Clalit Health Services - Shuali Clinic
    • Ramat Gan, HaMerkaz, Israel, 5262100
      • Sheba Medical Center
  • Il-ta
    • Tel Aviv, Il-ta, Israel, 51549
      • Diabetes Medical Center
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 9112001
      • Hadassah Medical Center
  • Ḥeifā
    • Haifa, Ḥeifā, Israel, 3109601
      • Rambam Health Care Campus
    • Haifa, Ḥeifā, Israel, 3515209
      • Linn Medical Center
• Mexico
  • Chihuahua, Mexico, 31238
    • Investigacion en Salud y Metabolismo S.C
  • D.f.
    • Mexico, D.f., Mexico, 11650
      • Centro Especializado en Diabetes Obesidad y Enfermedades
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Diseno y Planeacion en Investigacion Medica
    • Guadalajara, Jalisco, Mexico, 44600
      • Instituto Jalisciense de Investigacion en Diabetes y Obesida
  • Mx-jal
    • Guadalajara, Mx-jal, Mexico, 44150
      • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
  • N.l.
    • Monterrey, N.l., Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio González
  • Nuevo León
    • San Nicolás de los Garza, Nuevo León, Mexico, 66465
      • Unidad Médica para la Salud Integral
  • Tamaulipas
    • Ciudad Madero, Tamaulipas, Mexico, 89440
      • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
• Puerto Rico
  • Guaynabo, Puerto Rico, 00970
    • Paola Mansilla-Letelier, MD
  • Ponce, Puerto Rico, 00717
    • Research and Cardiovascular Corp.
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Martha Gomez Cuellar M.D.
• United Kingdom
  • Rotherham, United Kingdom, S65 1DA
    • Wickersley Health Centre - Clifton Medical Centre
  • Avon
    • Bath, Avon, United Kingdom, BA2 3HT
      • Oldfield Surgery
  • Gb-cam
    • Ely, Gb-cam, United Kingdom, CB7 5JD
      • Staploe Medical Centre
  • Gb-con
    • Fowey, Gb-con, United Kingdom, PL23 1DT
      • Fowey River Practice
    • Liskeard, Gb-con, United Kingdom, PL14 3XA
      • Oak Tree Surgery
    • Torpoint, Gb-con, United Kingdom, PL11 2TB
      • Rame Medical Ltd
  • Gb-dby
    • Chesterfield, Gb-dby, United Kingdom, S40 4AA
      • Royal Primary Care Chesterfield North west
  • Gb-dev
    • Plymouth, Gb-dev, United Kingdom, PL5 3JB
      • Knowle House Surgery
  • Gb-ham
    • Portsmouth, Gb-ham, United Kingdom, PO6 3LY
      • Queen Alexandra Hospital
  • Gb-hrt
    • Stevenage, Gb-hrt, United Kingdom, SG1 4AB
      • Lister Hospital
  • Gb-lan
    • Blackburn, Gb-lan, United Kingdom, BB2 1AX
      • Oakenhurst Medical Practice
  • Gb-wil
    • cHIPPENHAM, Gb-wil, United Kingdom, SN15 2SB
      • Rowden Surgery
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE5 4PW
      • Leicester General Hospital
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • University Hospital Coventry & Warwickshire
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research
    • Sheffield, Alabama, United States, 35660
      • Syed Research Consultants LLC
  • California
    • Huntington Park, California, United States, 90255
      • National Research Institute - Huntington Park
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Panorama City, California, United States, 91402
      • National Research Institute - Huntington Park
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
    • Tustin, California, United States, 92780
      • University Clinical Investigators, Inc.
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • CMR of Greater New Haven
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
    • Lake City, Florida, United States, 32055
      • East Coast Institute for Research at The Jones Center
    • Margate, Florida, United States, 33063
      • South Florida Clinical Research Institute
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
    • Miami, Florida, United States, 33165 3338
      • New Horizon Research Center
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research
    • Pembroke Pines, Florida, United States, 33027
      • South Broward Research
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • United Osteoporosis Center
    • Union City, Georgia, United States, 30291
      • Sky Clinical Research Network
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital & Clinic
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinic
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Diabetes and Endocrinology Center
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices and Research
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
  • Missouri
    • Springfield, Missouri, United States, 65810
      • Clinvest Research LLC
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • New York
    • Albany, New York, United States, 12206
      • Albany Medical College, Division of Community Endocrinology
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • Morehead City, North Carolina, United States, 28557
      • Diabetes & Endocrinology Consultants, PC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research LLC
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Inc
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group, Inc.
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine & Associates
    • Lansdale, Pennsylvania, United States, 19446
      • Green & Seidner Family Practice Associates
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15243
      • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes Research Center
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, Inc.
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
    • Sugar Land, Texas, United States, 77478
      • Carl R. Meisner Medical Clinic, PLLC
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
  • Virginia
    • Burke, Virginia, United States, 22015
      • Burke Internal Medicine and Research
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clinical Research Center
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have been diagnosed with type 2 diabetes mellitus (T2DM)
• Have HbA1c between ≥7.0% and ≤10.5%
• Be on stable treatment with unchanged dose of metformin >1500 mg/day for at least 3 months prior to screening
• Be of stable weight (±5%) for at least 3 months before screening
• Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Exclusion Criteria:

• Have type 1 diabetes mellitus
• Have had chronic or acute pancreatitis any time prior to study entry
• Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
• Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
• Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
• Have an estimated glomerular filtration rate <45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
• Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
• Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
• Have been taking any other diabetes medicines other than metformin during the last 3 months
• Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Active Comparator: 1 mg Semaglutide; 1 mg semaglutide administered SC once a week.	Drug: Semaglutide; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Weight Loss ≥5%	Percentage of Participants who Achieved Weight Loss ≥5%.	Week 40
Change From Baseline in HbA1c (5 mg)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 40
Change From Baseline in Body Weight	Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 40
Percentage of Participants Achieving an HbA1c Target Value of <7%	Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.	Week 40
Change From Baseline in Fasting Serum Glucose (FSG)	Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 40
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values	The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 40
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score	DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares).	Baseline, Week 40
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia	The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment.	Baseline through Safety Follow-Up (Up to Week 44)
Percentage of Participants Achieving an HbA1c Target Value of <5.7%	Percentage of Participants Achieving an HbA1c Target Value of <5.7%.	Week 40

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
• Ten Doesschate T, van der Vaart TW, Debisarun PA, Taks E, Moorlag SJCFM, Paternotte N, Boersma WG, Kuiper VP, Roukens AHE, Rijnders BJA, Voss A, Veerman KM, Kerckhoffs APM, Oever JT, van Crevel R, van Nieuwkoop C, Lalmohamed A, van de Wijgert JHHM, Netea MG, Bonten MJM, van Werkhoven CH. Bacillus Calmette-Guérin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial. Clin Microbiol Infect. 2022 Sep;28(9):1278-1285. doi: 10.1016/j.cmi.2022.04.009. Epub 2022 Apr 28.
• Frias JP, Davies MJ, Rosenstock J, Perez Manghi FC, Fernandez Lando L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515. doi: 10.1056/NEJMoa2107519. Epub 2021 Jun 25.

Helpful Links

• A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: T2DM; GLP-1 RA; Glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 17001 (REGISTRY: CNRS); I8F-MC-GPGL (Other Identifier: Eli Lilly and Company); 2018-004422-29 (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; Statistical Analysis Plan (SAP); Clinical Study Report (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