A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)

December 5, 2025 updated by: Eli Lilly and Company

A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 (Estimated)

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.
780

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 4

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CT LILLY (1-877-285-4559) or
  • Phone Number: : 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
    • Buenos Air
      • Morón, Buenos Air, Argentina, B1708EPE
        • CIAD Moron
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1056
        • Centro de Investigaciones Metabolicas (CINME)
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto de Investigaciones Clinicas Mar del Plata
      • San Nicolás de los Arroyos, Buenos Aires, Argentina, 2900
        • Go Centro Medico San Nicolas
    • Ciudad Aut
      • Buenos Aires, Ciudad Aut, Argentina, C1120AAC
        • Centro Medico Viamonte
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 4A1
        • Dr. M.B. Jones Inc.
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
      • Stouffville, Ontario, Canada, L4A 1H2
        • Stouffville Medical Centre
    • Quebec
      • Montreal, Quebec, Canada, H4N 2W2
        • 9109-0126 Quebec Inc.
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Diabetespraxis Mergentheim
      • Gelnhausen, Germany, 63571
        • Diabetes Zentrum Dr. Tews
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • ClinPhenomics CVC GmbH
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44869
        • Diabetes- und Stoffwechselpraxis Bochum
      • Essen, North Rhine-Westphalia, Germany, 45136
        • InnoDiab Forschung GmbH
    • Saarland
      • Saint Ingbert, Saarland, Germany, 66386
        • Zentrum für klinische Studien
    • Saxony
      • Pirna, Saxony, Germany, 01796
        • Arztpraxis Christine Kosch Pirna
    • Schleswig-Holstein
      • Oldenburg in Holstein, Schleswig-Holstein, Germany, 23758
        • Red-Institut GmbH
  • Israel
    • Central District
      • Holon, Central District, Israel, 5810001
        • Edith Wolfson Medical Center
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Central District, Israel, 5262100
        • Sheba medical center
      • Rehovot, Central District, Israel, 7610001
        • Kaplan Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Hadassah Medical Center
    • Northern District
      • Haifa, Northern District, Israel, 3339419
        • Bnai Zion Medical Center
      • Sakhnin, Northern District, Israel, 3081000
        • Clalit Health Services - Sakhnin Community Clinic
    • Southern District
      • Atlit, Southern District, Israel
        • Clalit Health Services - Atlit
    • Ḥeifā
      • Haifa, Ḥeifā, Israel, 3515209
        • Linn Medical Center
  • Italy
      • Catanzaro, Italy, 88100
        • AOU Renato Dulbecco
    • Apulia
      • Bari, Apulia, Italy, 70124
        • A.O.U.C. Policlinico di Bari
    • Campania
      • Napoli, Campania, Italy, 80131
        • University of Naples Federico II
    • Milano
      • Milan, Milano, Italy, 20138
        • Centro Cardiologico Monzino
    • Piedmont
      • Moncalieri, Piedmont, Italy, 10024
        • Ospedale Civile Santa Croce Pronto Soccorso
    • Sardinia
      • Olbia, Sardinia, Italy, 07026
        • Ospedale san Giovanni di Dio-Diabetologia
    • Sicily
      • Palermo, Sicily, Italy, 90129
        • A.O.U. Policlinico Paolo Giaccone
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • Azienda Ospedaliera Universitaria Pisana
  • Mexico
      • Chihuahua City, Mexico, 31217
        • Investigacion En Salud Y Metabolismo Sc
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Private Practice - Dr. Arechavaleta Granell Maria del Rosario
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Dorado Medical Complex
    • PR
      • Caguas, PR, Puerto Rico, 00725
        • San Juan Bautista School of Medicine - Clinical Research Unit
      • San Juan, PR, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
  • Romania
      • Galați, Romania, 800001
        • Milena Sante
      • Satu Mare, Romania, 440055
        • Clinica Korall
    • Bihor County
      • Oradea, Bihor County, Romania, 410147
        • Diabdana
    • Brașov County
      • Brasov, Brașov County, Romania, 500283
        • C.M.D.T.A. Neomed
    • București
      • Bucharest, București, Romania, 013764
        • Centrul Medical NutriLife
    • Constanța County
      • Mangalia, Constanța County, Romania, 905500
        • Gama Diamed
    • Prahova
      • Ploieşti, Prahova, Romania, 100179
        • Diabmed Dr. Popescu Alexandrina
  • Slovakia
      • Piešťany, Slovakia, 921 01
        • MEDIKALS
      • Považská Bystrica, Slovakia, 017 01
        • ProDia s.r.o.
      • Trnava, Slovakia, 917 01
        • JAL
    • Žilina Region
      • Vrútky, Žilina Region, Slovakia, 038 61
        • IRIDIA
  • United Kingdom
      • Rotherham, United Kingdom, S65 1DA
        • Wickersley Health Centre - Clifton Medical Centre
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
    • Cambridgeshire
      • Ely, Cambridgeshire, United Kingdom, CB7 5JD
        • Staploe Medical Centre
    • Devon
      • Plymouth, Devon, United Kingdom, PL5 3JB
        • Knowle House Surgery
    • Kingston Upon Hull
      • Hull, Kingston Upon Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Leicester General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Cahaba Research - Trussville
    • California
      • Canoga Park, California, United States, 91304
        • San Fernando Valley Health Institute
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research, Huntington Park
      • La Mesa, California, United States, 91942
        • Velocity Clinical Research, San Diego
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research, Westlake
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • North Hollywood, California, United States, 91606
        • Velocity Clinical Research, North Hollywood
      • Panorama City, California, United States, 91402
        • Velocity Clinical Research, Panorama City
      • Pomona, California, United States, 91766
        • Western University of Health Sciences
      • Santa Ana, California, United States, 92704
        • Velocity Clinical Research, Santa Ana
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • New England Research Associates, LLC
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispecialty Research, LLC
      • Margate, Florida, United States, 33063
        • South Florida Clinical Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University School of Medicine- Grady Campus
      • Gainesville, Georgia, United States, 30501
        • Center for Advanced Research & Education
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Qualmedica Research
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC
    • New York
      • Buffalo, New York, United States, 14221
        • Research Foundation of SUNY - University of Buffalo
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research, Inc
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic, P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
      • Spartanburg, South Carolina, United States, 29303
        • Velocity Clinical Research, Spartanburg
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
  • Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.

  • Have been on a stable treatment of metformin only at least 90 days preceding baseline

    • with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
    • <1500 mg/day in case of intolerance of full therapeutic dose.

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have a history of chronic or acute pancreatitis any time prior to study entry

  • Have a history of

    • proliferative diabetic retinopathy
    • diabetic macular edema, or
    • no proliferative diabetic retinopathy requiring immediate or urgent treatment

  • Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry

    • myocardial infarction
    • percutaneous coronary revascularization procedure
    • carotid stenting or surgical revascularization
    • nontraumatic amputation
    • peripheral vascular procedure (e.g., stenting or surgical revascularization)
    • cerebrovascular accident (stroke), or congestive heart failure
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
  • Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
  • Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.

  • Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.

    • Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

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: None (Open Label)

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: Tirzepatide
Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Active Comparator: Intensified Conventional Care Dose
Participants will receive an antihyperglycemic medication
Drug: Antihyperglycemic medication
As prescribed

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
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 104
Baseline, Week 104

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
Change from Baseline in HbA1c
Time Frame: Baseline, Week 208
Baseline, Week 208
Change from Baseline in Weight
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Weight
Time Frame: Baseline, Week 208
Baseline, Week 208
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 208
Baseline, Week 208
Change from Baseline in Fasting Serum Glucose (FSG)
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in FSG
Time Frame: Baseline, Week 208
Baseline, Week 208
Change from Baseline in Lipids
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Lipids
Time Frame: Baseline, Week 208
Baseline, Week 208
Percentage of Participants Achieving HbA1c <7.0%
Time Frame: Week 104
Week 104
Percentage of Participants Achieving HbA1c ≤6.5%
Time Frame: Week 104
Week 104
Percentage of Participants Achieving HbA1c <5.7%
Time Frame: Week 104
Week 104
Percentage of Participants Achieving HbA1c <7.0%
Time Frame: Week 208
Week 208
Percentage of Participants Achieving HbA1c ≤6.5%
Time Frame: Week 208
Week 208
Percentage of Participants Achieving HbA1c <5.7%
Time Frame: Week 208
Week 208
Change from Baseline in Weight loss of ≥5%,
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Weight loss of ≥10%
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Weight loss of ≥15%
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in Weight loss of ≥5%
Time Frame: Baseline, Week 208
Baseline, Week 208
Change from Baseline in Weight loss of ≥10%
Time Frame: Baseline, Week 208
Baseline, Week 208
Change from Baseline in Weight loss of ≥15%
Time Frame: Baseline, Week 208
Baseline, Week 208
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Time Frame: Week 104
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia
Week 104
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Time Frame: Week 208
A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG <54 mg/dL (<3.0 mmol/L) and/or severe hypoglycemia
Week 208
Change from Baseline in β-cell Glucose Sensitivity
Time Frame: Baseline, Week 104
β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)
Baseline, Week 104
Change from Baseline in β-cell glucose sensitivity
Time Frame: Baseline, Week 208
Change from baseline in β-cell glucose sensitivity assessed by OGTT
Baseline, Week 208
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Time Frame: Baseline, Week 104
Insulin Secretion Rate assessed by OGTT
Baseline, Week 104
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Time Frame: Baseline, Week 208
Insulin Secretion Rate assessed by OGTT
Baseline, Week 208
Change from Baseline in Postprandial Insulin Sensitivity Indices
Time Frame: Baseline, Week 104
Postprandial Insulin Sensitivity Indices assessed by OGTT
Baseline, Week 104
Change from Baseline in Postprandial Insulin Sensitivity Indices
Time Frame: Baseline, Week 208
Postprandial Insulin Sensitivity Indices assessed by OGTT
Baseline, Week 208
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
Time Frame: Baseline through Week 104
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Baseline through Week 104
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
Time Frame: Baseline through Week 208
Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT
Baseline through Week 208
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain
Time Frame: Baseline, Week 104
Baseline, Week 104
Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain
Time Frame: Baseline, Week 208
Baseline, Week 208

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.
August 1, 2022

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.
October 21, 2025

Study Completion (Estimated)

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.
November 1, 2027

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).
June 22, 2022

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.
June 22, 2022

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.
June 27, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
December 12, 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.
December 5, 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.
December 1, 2025

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.
  • 17205 (UIUC)
  • I8F-MC-GPHE (Other Identifier: Eli Lilly and Company)
  • 2022-000130-42 (EudraCT Number)
  • 2022-5010733-40-00 (Other Identifier: EU Trial Number)
  • U1111-1282-0263 (Registry Identifier: World Health Organization)

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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