A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)

August 13, 2026 updated by: Eli Lilly and Company

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
559

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 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

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-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China, 241001
        • Wannan Medical College Yijishan Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Hospital
      • Beijing, Beijing Municipality, China, 101200
        • Beijing Pinggu District Hospital
      • Beijing, Beijing Municipality, China, 100000
        • Luhe Hospital
    • Guangdong
      • Foshan, Guangdong, China, 528399
        • Shunde Hospital of Southern Medical Univesity
      • Huizhou, Guangdong, China, 516001
        • Huizhou Municipal Central Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Nanyang, Henan, China, 473001
        • Nanyang First People's Hospital
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201200
        • Pudong New Area People's Hospital Shanghai
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
  • India
    • Gujarat
      • Vadodara, Gujarat, India, 390021
        • GMERS Medical College and General Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • M S Ramaiah Medical College and Hospitals
      • Bangalore, Karnataka, India, 560092
        • Medstar Speciality Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400058
        • BSES MG Hospital
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Pune, Maharashtra, India, 411001
        • Grant Medical Foundation - Ruby Hall Clinic
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Madras Diabetes Research Foundation
    • Telangana
      • Hyderabad, Telangana, India, 500072
        • Kumudini Devi Diabetes Research Center
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
  • Japan
      • Kumamoto, Japan, 860-0863
        • Morinaga Ueno Clinic
      • Ōita, Japan, 870-0039
        • Abe Clinic
    • Chiba
      • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
        • Tokuyama Clinic
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 805-8508
        • Steel Memorial Yahata Hospital
    • Hokkaido
      • Chitose, Hokkaido, Japan, 066-0032
        • Hasegawa Medical Clinic
    • Ibaraki
      • Mito, Ibaraki, Japan, 311-4153
        • MinamiAkatsukaClinic
    • Kagawa-ken
      • Zentsujichó, Kagawa-ken, Japan, 765-0071
        • Iwamoto Clinic
    • Kanagawa
      • Chigasaki, Kanagawa, Japan, 253-0044
        • Hayashi Diabetes Internal Medicine Clinic
      • Yamato-shi, Kanagawa, Japan, 242-0004
        • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Fukuwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0002
        • The Institute of Medical Science, Asahi Life Foundation
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • Mexico
      • Chihuahua City, Mexico, 31110
        • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
      • Querétaro, Mexico, 76100
        • PanAmerican Clinical Research - Querétaro - Avenida Antea
      • Veracruz, Mexico, 91900
        • FAICIC S. de R.L. de C.V.
      • Veracruz, Mexico, 91851
        • Instituto Veracruzano en Investigación Clínica S.C.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44150
        • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
      • Guadalajara, Jalisco, Mexico, 44860
        • Salud Cardiovascular
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro de Investigacion Medica Integral
      • Zapopan, Jalisco, Mexico, 44260
        • Centro de Investigacion Medica de Occidente, S.C.
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Puerto Rico Health Institute
      • San Juan, Puerto Rico, 00926
        • Advance Medical Research Center
  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Syed Research Consultants Llc
    • Arizona
      • Surprise, Arizona, United States, 85378
        • Epic Medical Research - Surprise
      • Tucson, Arizona, United States, 85712
        • Quality of Life Medical & Research Center
    • California
      • Escondido, California, United States, 92025
        • Neighborhood Healthcare Institute of Health
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research, Huntington Park
      • Long Beach, California, United States, 90815
        • ARK Clinical Research
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research, Westlake
      • Norco, California, United States, 92860
        • Infinity Clinical Research - Norco
      • San Ramon, California, United States, 94583
        • Norcal Endocrinology & Internal Medicine
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Connecticut Clinical Research - Cromwell
    • Florida
      • Coconut Creek, Florida, United States, 33073
        • Invictus Clinical Research Group
      • DeLand, Florida, United States, 32720
        • Hillcrest Medical Research
      • Maitland, Florida, United States, 32751
        • K2 Medical Research
      • Miami Lakes, Florida, United States, 33016
        • Global Health Research Center, Inc.
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Family First Medical Center
    • Indiana
      • Muncie, Indiana, United States, 47304
        • American Health Network of Indiana, LLC - Muncie
    • Kansas
      • Wichita, Kansas, United States, 67218
        • Tekton Research - Wichita
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Alliance for Multispecialty Research, LLC
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Revival Research Institute
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • New York
      • Brooklyn, New York, United States, 11215
        • Ellipsis Research Group - Brooklyn - 7th Street
      • Manlius, New York, United States, 13104
        • Central New York Clinical Research
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • New Bern, North Carolina, United States, 28562
        • Lucas Research - New Bern
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Centricity Research Dublin Multispecialty
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research, LLC
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic, P.C.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • The Research Center of The Upstate
      • Lancaster, South Carolina, United States, 29720
        • MDFirst Research, LLC
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic
    • Texas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Houston, Texas, United States, 77040
        • Juno Research
      • Houston, Texas, United States, 77079
        • Endocrine Ips, Pllc
      • Houston, Texas, United States, 77089
        • Amir A Hassan, MD, PA
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine and Research

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have Type 2 Diabetes
  • Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
  • Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
  • Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
  • Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

  • Have Type 1 Diabetes
  • Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
  • Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  • Have New York Heart Association functional classification IV congestive heart failure.
  • Have acute or chronic pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
Drug: Placebo
Administered orally
Experimental: 3 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: 12 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: 36 mg Orforglipron
Participants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c
Time Frame: Baseline, Week 40
  • Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.
  • Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ [less than or equal to] 8.0%, > [greater than] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)
Time Frame: Week 40
Percentage of participants with an HbA1c target value of less than (<) 7.0% (53 millimoles per mole [mmol/mol]) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no).
Week 40
Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)
Time Frame: Week 40
Percentage of Participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no).
Week 40
Change From Baseline in Fasting Serum Glucose (FSG)
Time Frame: Baseline, Week 40
Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ [less than or equal to] 8.0%, > [greater than] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40
Percent Change From Baseline in Body Weight
Time Frame: Baseline, Week 40
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40
Change From Baseline in Body Weight
Time Frame: Baseline, Week 40
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40
Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol
Time Frame: Baseline, Week 40
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40
Percent Change From Baseline in Triglycerides
Time Frame: Baseline, Week 40
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)
Time Frame: Baseline, Week 40
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction
Time Frame: Week 40
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no).
Week 40
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 40
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 40
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores
Time Frame: Baseline, Week 40
The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
Baseline, Week 40

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.

General Publications

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 9, 2023

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.
April 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2025

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).
July 25, 2023

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.
July 25, 2023

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.
August 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

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.
August 13, 2026

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.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18564
  • J2A-MC-GZGT (Other Identifier: Eli Lilly and Company)
  • U1111-1290-5157 (Other Identifier: UTN 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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