A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

July 23, 2024 updated by: Eli Lilly and Company

A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

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

  • United States
    • California
      • Anaheim, California, United States, 92801
        • CenExel ACT
    • Florida
      • Miami, Florida, United States, 33143
        • Qps-Mra, Llc
    • Texas
      • Dallas, Texas, United States, 75247
        • Labcorp CRU

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

Yes

Description

Inclusion Criteria:

  • Male and female participants who are overtly healthy as determined by medical evaluation (Part A)
  • Participants with T2DM diagnosed greater than 1 year before enrollment (Part A and Part B)
  • Have a body mass index within the range of 18.5 to less than or equal to (<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants.
  • Male or female participants of nonchildbearing potential

Exclusion Criteria:

  • Have proliferative retinopathy or maculopathy and/or severe neuropathy
  • Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months
  • Have received chronic systemic glucocorticoid therapy in the past 3 months
  • Are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (Part A)
Placebo administered SC.
Drug: Placebo
Administered SC.
Experimental: LY3938577 (Part A)
LY3938577 administered Subcutaneously (SC).
Drug: LY3938577
Administered SC.
Active Comparator: Insulin degludec (Part A)
Insulin degludec administered SC.
Drug: Insulin degludec
Administered SC.
Experimental: LY3938577 (Part B)
LY3938577 administered SC.
Drug: LY3938577
Administered SC.
Active Comparator: Insulin degludec (Part B)
Insulin degludec administered SC.
Drug: Insulin degludec
Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Time Frame: Baseline up to 16 days
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Baseline up to 16 days
Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Time Frame: Baseline up to 44 days
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Baseline up to 44 days
Part A: Incidence of Hypoglycemia
Time Frame: Baseline up to 16 days
Baseline up to 16 days
Part B: Incidence of Hypoglycemia
Time Frame: Baseline up to 44 days
Baseline up to 44 days
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: Baseline up to 16 days
Baseline up to 16 days
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: Baseline up to 44 days
Baseline up to 44 days
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time Frame: Baseline up to 16 days
Baseline up to 16 days
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time Frame: Baseline up to 44 days
Baseline up to 44 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)
Time Frame: Part A: Predose up to 16 Days and Part B: Predose up to 44 Days
Part A: Predose up to 16 Days and Part B: Predose up to 44 Days

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 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)

November 17, 2023

Primary Completion (Actual)

June 28, 2024

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18779
  • J4P-MC-IYAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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