A Study of LY3437943 in Participants With Type 2 Diabetes

June 8, 2023 updated by: Eli Lilly and Company

A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 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.
281

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 2

Contacts and Locations

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

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Advanced Clinical Research, LLC
      • Manati, Puerto Rico, 674
        • Manati Center for Clinical Research
      • San Juan, Puerto Rico, 909
        • Latin Clinical Trial Center
  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Syed Research Consultants Llc
    • California
      • Canoga Park, California, United States, 91304
        • San Fernando Valley Health Institute
      • Fresno, California, United States, 93720
        • Valley Endocrine, Fresno
      • Huntington Park, California, United States, 90255
        • National Research Institute - Huntington Park
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Panorama City, California, United States, 91402
        • National Research Institute - Panorama City
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • Riverside, California, United States, 92503
        • Artemis Institute for Clinical Research
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Santa Ana, California, United States, 92704
        • National Research Institute (NRI) - Santa Ana
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Margate, Florida, United States, 33063
        • South Florida Clinical Research Institute
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
      • Weston, Florida, United States, 33331
        • Encore Medical Research - Weston
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Boise, Idaho, United States, 83702
        • Humphreys Diabetes Center
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
      • Rexburg, Idaho, United States, 83440
        • Elite Clinical Trials
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinic
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
    • Mississippi
      • Petal, Mississippi, United States, 39465
        • MediSync Clinical Research
    • Missouri
      • Springfield, Missouri, United States, 65810
        • Clinvest Research LLC
    • Montana
      • Kalispell, Montana, United States, 59901
        • Logan Health Research
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Medical Group, Inc.
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, LLC
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • The Research Center of The Upstate
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Fort Worth, Texas, United States, 76132
        • Diabetes and Thyroid Center of Fort Worth
      • Houston, Texas, United States, 77079
        • Endocrine Ips, Pllc
      • Houston, Texas, United States, 77089
        • Laila A Hassan, MD, PA
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • North Richland Hills, Texas, United States, 76180
        • North Hills Family Medicine/North Hills Medical Research
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center
      • Tacoma, Washington, United States, 98405
        • Universal Research Group
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have Type 2 Diabetes (T2D)
  • Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.

Exclusion Criteria:

  • Have type 1 diabetes mellitus (T1DM)
  • Have ketoacidosis
  • Have retinopathy, maculopathy
  • Have history of pancreatitis
  • Have obesity induced by other endocrine disorders
  • Have uncontrolled hypertension
  • Have acute or chronic hepatitis
  • Have chronic kidney disease
  • Have an autoimmune abnormality for example, lupus or rheumatoid arthritis
  • Have an active or untreated malignancy

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.
Experimental: 0.5 milligrams (mg) LY3437943
Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
Drug: LY3437943
Administered SC
Experimental: 4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
Administered SC
Experimental: 4 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
Administered SC
Experimental: 8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
Drug: LY3437943
Administered SC
Experimental: 8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
Drug: LY3437943
Administered SC
Experimental: 12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.
Drug: LY3437943
Administered SC
Active Comparator: 1.5 mg Dulaglutide
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
Drug: Dulaglutide
Administered SC
Placebo Comparator: Placebo
Participants received placebo administered as SC injection QW.
Drug: Placebo
Administered SC

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 Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 24 Weeks
Change in HbA1c (%) from baseline in LY3437943 relative to placebo. 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 calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.
Baseline, 24 Weeks

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, 24 Weeks
Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.
Baseline, 24 Weeks
Change From Baseline in HbA1c
Time Frame: Baseline, 36 Weeks
Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline Body Mass Index (BMI) Group (<30 kilograms/square meter (kg/m2), >=30 kg/m2)*Time + Baseline*Time.
Baseline, 36 Weeks
Percentage of Participants Reaching HbA1c <7.0%
Time Frame: Week 24
Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, ≥30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate.
Week 24
Percentage of Participant Reaching HbA1c <7.0%
Time Frame: Week 36
Percentage of participants reaching HbA1c <7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum [<30 kg/m2, ≥30 kg/m2] as fixed effects, and baseline HbA1c value as a covariate.
Week 36
Change From Baseline in Fasting Blood Glucose (FBG)
Time Frame: Baseline, 24 Weeks
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.
Baseline, 24 Weeks
Change From Baseline in Fasting Blood Glucose (FBG)
Time Frame: Baseline, 36 Weeks
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time.
Baseline, 36 Weeks
Change From Baseline in Body Weight
Time Frame: Baseline, 24 Weeks
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Strata*Time + Baseline*Time.
Baseline, 24 Weeks
Change From Baseline in Body Weight
Time Frame: Baseline, 36 Weeks
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment*Time + Baseline HbA1c Group (<=8.5%, >8.5%)*Time + Baseline BMI Group (<30kg/m2, >=30kg/m2)*Time + Baseline*Time.
Baseline, 36 Weeks
Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943
Time Frame: Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36
The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.
Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

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.
May 13, 2021

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.
July 8, 2022

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.
October 27, 2022

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).
April 29, 2021

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.
April 29, 2021

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.
April 30, 2021

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.
July 3, 2023

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.
June 8, 2023

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.
June 1, 2023

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.
  • 17774
  • J1I-MC-GZBD (Other Identifier: Eli Lilly and Company)

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 or 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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