A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

April 17, 2026 updated by: Eli Lilly and Company

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/ LY3650150 in Adult Participants With Perennial Allergic Rhinitis

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis.

Participants can expect study participation to last up to 29.5 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

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

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Not yet recruiting
        • Hôpital Erasme, Service Pharmacie
        • Contact:
          • Phone Number: +32 2 555 52 39
        • Principal Investigator:
          • Alain Michils
      • Erpent, Belgium, 5101
        • Recruiting
        • Pneumocare
        • Principal Investigator:
          • Jean-Benoît Martinot
        • Contact:
          • Phone Number: +32 495 82 34 43
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • Uz Gent
        • Principal Investigator:
          • Philippe Geveart
        • Contact:
          • Phone Number: 0032 9 332 29 73
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven, Pharmacy
        • Principal Investigator:
          • Peter Hellings
        • Contact:
          • Phone Number: +32 16 34 12 45
      • Liège, Belgium, 4000
        • Recruiting
        • Hôpital de la Citadelle
        • Contact:
          • Phone Number: +32 (0)4 321 52 37
        • Principal Investigator:
          • Helene Simonis
  • China
      • Beijing, China, 100032
        • Recruiting
        • Internal Medicine Building
        • Contact:
          • Phone Number: 13691496059
        • Principal Investigator:
          • Mei Zhu
      • Beijing, China, 100730
        • Recruiting
        • Department of Nasal Allergy
        • Principal Investigator:
          • Chengshuo Wang
        • Contact:
          • Phone Number: 13269208812
      • Changsha, China, 410013
        • Recruiting
        • The third xiangya hospital of Central South University
        • Principal Investigator:
          • Guolin Tan
        • Contact:
          • Phone Number: 0731-88618931/15974183357
      • Guangzhou, China, 510000
        • Recruiting
        • GCP Pharmacy
        • Principal Investigator:
          • chang Lin
        • Contact:
          • Phone Number: 13799400365
      • Hangzhou, China, 310014
        • Recruiting
        • Zhejiang People's Hospital
        • Principal Investigator:
          • Lizhong Su
        • Contact:
          • Phone Number: 0571-85893645/13732293639
      • Jingzhou, China, 434020
        • Recruiting
        • Jingzhou Central Hospital
        • Principal Investigator:
          • Lijia Wan
        • Contact:
          • Phone Number: 18171998217
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Jing Ye
        • Contact:
          • Phone Number: 0791-88692982
      • Nanchang, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Hongbing Liu
        • Contact:
          • Phone Number: 18702556606
      • Nanning, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Phone Number: 18377223715
        • Principal Investigator:
          • Guangyao Liu
      • Nanning, China, 530021
        • Not yet recruiting
        • People's Hospital of Guangxi Zhuang Autonomous Region
        • Principal Investigator:
          • Shenhong Qu
        • Contact:
          • Phone Number: 18277195903
      • Shanghai, China, 200065
        • Recruiting
        • Tongji Hospital
        • Contact:
          • Phone Number: 021-66111103
        • Principal Investigator:
          • Shaoqing Yu
      • Wuhan, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • Yu Xu
      • Wuhan, China, 430022
        • Recruiting
        • Outpatient Department, Union Hospital
        • Principal Investigator:
          • Jianjun Chen
        • Contact:
          • Phone Number: 18971294483/19971138040
      • Wuhan, China, 430014
        • Recruiting
        • Outpatient building
        • Principal Investigator:
          • Wei Chen
        • Contact:
          • Phone Number: 18071083208
      • Yangzhou, China, 225001
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Principal Investigator:
          • Bing Guan
        • Contact:
          • Phone Number: 18940254497/18940254987
      • Yangzhou, China, 225012
        • Recruiting
        • Yangzhou University
        • Contact:
          • Phone Number: 18051062223
        • Principal Investigator:
          • Pan Zhang
      • Zhongshan, China, 528403
        • Not yet recruiting
        • Zhongshan City People's Hospital
        • Principal Investigator:
          • Minyi Fu
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitätsmedizin Berlin Klinik für Dermatologie
        • Principal Investigator:
          • Margitta Worm
        • Contact:
          • Phone Number: +49 30 450 518 305
      • Dresden, Germany, 1307
        • Not yet recruiting
        • Universitätsklinikum Carl Gustav Carus an der TU
        • Contact:
          • Phone Number: '+49 351 45813506
        • Principal Investigator:
          • Marie-Luise Polk
      • Dresden, Germany, 1139
        • Recruiting
        • Praxis für HNO und Allergologie
        • Principal Investigator:
          • Yury Yarin
        • Contact:
          • Phone Number: '+49 1743195510
      • Frankfurt am Main, Germany, 60596
        • Not yet recruiting
        • IKF Pneumologie
        • Contact:
          • Phone Number: '+49 69 695972580
        • Principal Investigator:
          • Marc Kornmann
      • Heidelberg, Germany, 69115
        • Recruiting
        • Siteworks - Zentrum für klinische Studien Heidelberg
        • Principal Investigator:
          • Niels-Christian Hoellger
        • Contact:
          • Phone Number: +4952510000000
      • Marburg, Germany, 35043
        • Recruiting
        • Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
        • Principal Investigator:
          • Oliver Pfaar
        • Contact:
          • Phone Number: +49 6421 58 66478
      • Weisbaden, Germany, 65183
        • Recruiting
        • Zentrum für Rhinologie und Allergologie
        • Principal Investigator:
          • Jan Hagemann
        • Contact:
          • Phone Number: +49 611 308 608 270
  • Poland
      • Kielce, Poland, 25-355
        • Recruiting
        • Polimedica PTG Kielce
        • Contact:
          • Phone Number: 48791002233
        • Principal Investigator:
          • Latos Anna
      • Krakow, Poland, 31-513
        • Recruiting
        • Centrum Medyczne Promed ul. Olszańska 5G
        • Principal Investigator:
          • Piotr Lach
        • Contact:
          • Phone Number: +48 602460190
      • Krakow, Poland, 31-623
        • Recruiting
        • Malopolskie Centrum Alergologii
        • Principal Investigator:
          • Malgorzata Bederska
      • Lodz, Poland, 90-302
        • Recruiting
        • gab. 114, ul. inż. pilota Wigury
        • Contact:
          • Phone Number: +48 508 489 097
        • Principal Investigator:
          • Cezary Chwala
      • Lublin, Poland, 20-412
        • Recruiting
        • ETG Lublin
        • Contact:
          • Phone Number: 48 575002885
        • Principal Investigator:
          • Zofia Bartnik
      • Piła, Poland, 64-920
        • Recruiting
        • Centrum Alergologii Teresa Hofman Sp z.o.o.
        • Contact:
          • Phone Number: 48506123774
        • Principal Investigator:
          • Anna Hofman
      • Rzeszów, Poland, 35-205
        • Recruiting
        • EMED Centrum Usług Medycznych
        • Contact:
          • Phone Number: 48608380738
        • Principal Investigator:
          • Slawomir Tokarski
      • Skierniewice, Poland, 96-100
        • Recruiting
        • ClinMedica Research
        • Contact:
          • Phone Number: 48 609 702 525
        • Principal Investigator:
          • Bozena Kucinska
      • Tarnów, Poland, 33-100
        • Recruiting
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
        • Principal Investigator:
          • Bernadetta Majorek-Olechowska
        • Contact:
          • Phone Number: +48 516 772 221
      • Warsaw, Poland, 02-793
        • Recruiting
        • ETG Warszawa
        • Contact:
          • Phone Number: 48575000824
        • Principal Investigator:
          • Beata Adamczyk
      • Wroclaw, Poland, 53-201
        • Recruiting
        • ALL-MED - Specjalistyczna Opieka Medyczna
        • Contact:
          • Phone Number: +48 731 021 221
        • Principal Investigator:
          • Marek Jutel
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje university Haeundae Paik Hospital
        • Principal Investigator:
          • Chan Sun Park
        • Contact:
          • Phone Number: 82-10-4200-8063
      • Incheon, South Korea, 21565
        • Not yet recruiting
        • B1F, Pharmacy department, Gachon University Gil Medical Center
        • Contact:
          • Phone Number: 82-32-460-9466
        • Principal Investigator:
          • Sang-Pyo Lee
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Sungwoo Cho
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Min-Seok Rha
        • Contact:
          • Phone Number: 82-2-2228-0515
      • Seoul, South Korea, 05278
        • Recruiting
        • Kyunghee University Hospital at Gangdong
        • Principal Investigator:
          • KunHee Lee
      • Seoul, South Korea, 7061
        • Not yet recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
          • Phone Number: 82-2-870-3928
        • Principal Investigator:
          • Dae Woo Kim
      • Seoul, South Korea, 8308
        • Not yet recruiting
        • Clinical trial Pharmacy
        • Contact:
          • Phone Number: 82-2-2626-1624
        • Principal Investigator:
          • Heung-Man Lee
      • Seoul, South Korea, 6273
        • Recruiting
        • Gangnam Severance Hospital 211
        • Contact:
          • Phone Number: 82-2-2019-2929
        • Principal Investigator:
          • Kyung-Su Kim
  • United States
    • California
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Allergy and Asthma Specialists Medical Group
        • Principal Investigator:
          • Steven Weinstein
        • Contact:
          • Phone Number: 714-848-8585
      • Inglewood, California, United States, 90301
        • Recruiting
        • 310 Clinical Research
        • Contact:
          • Phone Number: 310-878-2636
        • Principal Investigator:
          • Soheil Hekmat
      • Laguna Niguel, California, United States, 92677
        • Recruiting
        • Allergy & Asthma Associates of Southern California dba. Southern California Research
        • Contact:
          • Phone Number: 949-276-4917
        • Principal Investigator:
          • Warner Carr
      • San Diego, California, United States, 92123
        • Recruiting
        • Allergy and Asthma
        • Principal Investigator:
          • Bob Geng
        • Contact:
          • Phone Number: 858-268-2368 ext. 143
    • Colorado
      • Colorado Springs, Colorado, United States, 80907-6231
        • Recruiting
        • Asthma and Allergy Associates, PC
        • Contact:
          • Phone Number: 719-473-8330 x5
        • Principal Investigator:
          • Luke Webb
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Not yet recruiting
        • Allergy and Asthma Diagnostic Center
        • Contact:
          • Phone Number: 850-386-8034-X307
        • Principal Investigator:
          • Ronald Saff
      • Tampa, Florida, United States, 33613
        • Not yet recruiting
        • University of South Florida
        • Contact:
          • Phone Number: 813-631-4024
        • Principal Investigator:
          • Thomas Casale
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern University
        • Contact:
          • Phone Number: 312-695-6518
        • Principal Investigator:
          • Anju Peters
      • River Forest, Illinois, United States, 60305
        • Recruiting
        • Asthma Allergy Center of Chicago
        • Principal Investigator:
          • Rachana Shah
        • Contact:
          • Phone Number: 708-695-4259
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • Bluegrass Allergy Research
        • Principal Investigator:
          • William Greisner
        • Contact:
          • Phone Number: 859-303-7191
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Respiratory Medicine Research Institute of Michigan, PLC
        • Contact:
          • Phone Number: 734-528-0477
        • Principal Investigator:
          • Jeffrey Leflein
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Recruiting
        • Clinical Research Institute
        • Principal Investigator:
          • Gary Berman
        • Contact:
          • Phone Number: 612-333-2200 ext 378
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Not yet recruiting
        • University of Missouri Hospital
        • Principal Investigator:
          • Christine Franzese
        • Contact:
          • Phone Number: 573-882-2549
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Allergy and Asthma Consultants
        • Contact:
          • Phone Number: 314-991-5117
        • Principal Investigator:
          • William Johnson
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Asthma and Allergy Center
        • Contact:
          • Phone Number: 402-592-2055
        • Principal Investigator:
          • Linda Ford
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Recruiting
        • Circuit Clinical/Hudson-Essex Allergy
        • Principal Investigator:
          • Mark Weinstein
      • Hamilton, New Jersey, United States, 08619
        • Recruiting
        • Circuit Clinical/Mercer Allergy and Pulmonary Associates
        • Contact:
          • Phone Number: 201-401-0713
        • Principal Investigator:
          • Peter Ricketti
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Dr. Patrick Perin
        • Principal Investigator:
          • Patrick Perin
    • New York
      • Horseheads, New York, United States, 14845
        • Recruiting
        • Smith Allergy and Asthma
        • Principal Investigator:
          • Christopher Smith
        • Contact:
          • Phone Number: 607-463-2223
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Not yet recruiting
        • Allergy Partners
        • Principal Investigator:
          • Ellen Sher
        • Contact:
          • Phone Number: 732-695-2555
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Allergy Partners
        • Principal Investigator:
          • David Cypcar
        • Contact:
          • Phone Number: 828-348-7047
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Bernstein Clinical Research Center, LLC
        • Contact:
          • Phone Number: 314-991-5117
        • Principal Investigator:
          • David Bernstein
    • Oregon
      • Portland, Oregon, United States, 97202
        • Recruiting
        • Northwest Research Center
        • Contact:
          • Phone Number: 503-238-6233
        • Principal Investigator:
          • Subramaniam Seetharaman
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy and Clinical Immunology Associates
        • Principal Investigator:
          • Michael Palumbo
        • Contact:
          • Phone Number: 412-833-4051 Ext 116
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • AARA Research Center
        • Contact:
          • Phone Number: 214-365-0365
        • Principal Investigator:
          • W LUMRY
      • Kerrville, Texas, United States, 78028
        • Recruiting
        • Kerrville Allergy and Asthma Associates
        • Principal Investigator:
          • Dale Mohar
        • Contact:
          • Phone Number: 830-896-1433
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Recruiting
        • Allergy, Asthma & Sinus Center
        • Contact:
          • Phone Number: 414-529-8519
        • Principal Investigator:
          • Gary Steven

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physician-diagnosed perennial allergic rhinitis (PAR).
  • Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
  • The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test.
  • A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
  • Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.

Exclusion Criteria:

  • Have received a dose of lebrikizumab.
  • Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.
  • Have received treatment with any rescue medication during the run-in period.

  • Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:

    • Any current or prior use of biologics indicated for asthma or AD are prohibited.
    • B cell-depleting biologics, including rituximab, within 6 months.
    • Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
    • Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline.
  • Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period.
  • Anticipates significant changes in their daily environmental exposure.
  • Has a known history of recurrent acute or chronic sinusitis.
  • Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.

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
Intervention / Treatment
Experimental: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Drug: LY3650150
Administered SC
Drug: Standard therapy for INCS
Administered as intranasal spray
Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Drug: LY3650150
Administered SC
Drug: Standard therapy for INCS
Administered as intranasal spray
Placebo Comparator: Placebo Q2W/Q4W
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Drug: Placebo
Administered SC
Drug: Standard therapy for INCS
Administered as intranasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Time Frame: Baseline, Week 16
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Baseline, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean CFBL in TNSS at Week 4
Time Frame: Baseline, Week 4
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Baseline, Week 4
Mean CFBL in TNSS at Week 56
Time Frame: Baseline, Week 56
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Baseline, Week 56
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Time Frame: Baseline, Week 16
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Baseline, Week 16
Mean CFBL in RQLQ(S) Activities Domain at Week 56
Time Frame: Baseline, Week 56
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment)
Baseline, Week 56
Mean CFBL in RQLQ(S) Total Score at Week 16
Time Frame: Baseline, Week 16
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Baseline, Week 16
Mean CFBL in RQLQ(S) Total Score at Week 56
Time Frame: Baseline, Week 56
The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Baseline, Week 56
Mean CFBL in Postnasal Drip Score at Week 16
Time Frame: Baseline, Week 16
Postnasal drip is mucus drainage down the throat, as part of their Allergic Rhinitis (AR), will be rated by participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours.
Baseline, Week 16

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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)

April 26, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18789
  • J2T-MC-KGBT (Other Identifier: Eli Lilly and Company)
  • 2023-508817-18-00 (Other Identifier: EU Clinical Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant 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 European Union (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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