A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin

July 10, 2026 updated by: Eli Lilly and Company

A Phase 2, Randomized, Open-Label, Comparator-Controlled Trial to Evaluate the Efficacy and Safety of LY3938577 in Study Participants, With Type 2 Diabetes Previously Treated With Basal Insulin

The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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

  • Argentina
      • Buenos Aires, Argentina, C1119ACN
        • CIPREC
      • Buenos Aires, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e investigación
      • Buenos Aires, Argentina, 1424
        • Cicemo Srl
      • CABA, Argentina, 1204
        • Instituto Centenario
      • Rosario, Argentina, 2000
        • Instituto Médico Catamarca IMEC
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Tucson Clinical Research Institute
    • California
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research
      • Hollywood, Florida, United States, 33024
        • Encore Medical Research
      • Lakeland, Florida, United States, 33805
        • Clinical Research of Central Florida
      • Weston, Florida, United States, 33331
        • Encore Medical Research - Weston
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diabetes and Endocrinology Research Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare - Wilmington
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • AMR Clinical
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
    • Texas
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology, P.A.
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Houston, Texas, United States, 77040
        • Juno Research
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
      • Weslaco, Texas, United States, 78596
        • Texas Valley Clinical Research
    • Utah
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have type 2 diabetes
  • Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening
  • Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive
  • Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)

Exclusion Criteria:

  • Have type 1 diabetes

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
Intervention / Treatment
Experimental: LY3938577
Participants will receive LY3938577 subcutaneously (SC)
Drug: LY3938577
Administered SC
Active Comparator: Degludec
Participants will receive degludec SC
Drug: Degludec
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)
Time Frame: Baseline through Week 20
Baseline through Week 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis)
Time Frame: Baseline through Week 20
Baseline through Week 20
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 20
Baseline, Week 20
Pharmacokinetics (PK): Average Concentration of LY3938577
Time Frame: Baseline through Week 20
Baseline through Week 20

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

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)

October 13, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 9, 2025

First Submitted That Met QC Criteria

October 9, 2025

First Posted (Actual)

October 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27409
  • J4P-MC-IYAC (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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