A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04143802
Collaborator
(none)
72
Enrollment
4
Locations
3
Arms
12.4
Actual Duration (Months)
18
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to learn about the side effects of LY3437943 when given to participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date :
Dec 18, 2019
Actual Primary Completion Date :
Dec 28, 2020
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3437943

LY3437943 administered subcutaneously (SC)

Drug: LY3437943
Administered SC

Active Comparator: Dulaglutide

Dulaglutide administered SC

Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265
  • Placebo Comparator: Placebo

    Placebo administered SC

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 106]

      A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943 [Baseline through study completion (12 weeks)]

      PK: AUC of LY3437943

    2. PK: Maximum Concentration (Cmax) of LY3437943 [Baseline through study completion (12 weeks)]

      PK: Cmax of LY3437943

    3. Change from Baseline in Mean Daily Plasma Glucose (PG) [Baseline through Day 80]

      Change from baseline in mean daily PG from 6-point PG profile

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus

    • Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening

    • Have had a stable body weight for the 3 months prior to randomization (<5% body weight change)

    • Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive

    • Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose

    • Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal

    Exclusion Criteria:
    • Have type 1 diabetes mellitus or latent autoimmune diabetes in adults

    • Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening

    • Have a known clinically significant gastric emptying abnormality

    • Have had an episode of severe hypoglycemia

    • Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of

    500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening

    • Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3X upper limit of normal (ULN) at screening and/or Day -2

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
    2Miami Research AssociatesMiamiFloridaUnited States33143
    3PRA InternationalLenexaKansasUnited States66219
    4Clinical Trials of Texas, Inc.San AntonioTexasUnited States78229

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04143802
    Other Study ID Numbers:
    • 17137
    • J1I-MC-GZBB
    First Posted:
    Oct 29, 2019
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Jan 15, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2021