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A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05377333
Collaborator
(none)
86
Enrollment
4
Locations
4
Arms
15.7
Anticipated Duration (Months)
21.5
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in 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. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 Alone and in Combination With GLP-1 RA in Patients With Type 2 Diabetes
Actual Study Start Date :
Jun 2, 2022
Anticipated Primary Completion Date :
Sep 22, 2023
Anticipated Study Completion Date :
Sep 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3457263 (Alone)

LY3457263 administered subcutaneously (SC).

Drug: LY3457263
Administered SC.
Placebo Comparator: Placebo (Alone)

Placebo administered SC.

Drug: Placebo
Administered SC.
Experimental: LY3457263 + Dulaglutide

LY3457263 in combination with dulaglutide administered SC.

Drug: LY3457263
Administered SC.

Drug: Dulaglutide
Administered SC.
Other Names:
  • LY2189265

    		•
    Experimental: Placebo + Dulaglutide

    Placebo in combination with dulaglutide administered SC.

    Drug: Placebo
    Administered SC.

    Drug: Dulaglutide
    Administered SC.
    Other Names:
  • LY2189265

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Predose up to 16 weeks]

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

    Secondary Outcome Measures

    1. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263 [Pre-dose on Day 1 up to 85 days post-dose]

      PK: AUC of LY3457263

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants with type 2 diabetes (T2D) at least 6 months before screening

    • Participants treated for T2D with diet and exercise, with or without metformin

    • Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%

    • Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)

    • Male participants who agree to use effective methods of contraception and female participants not of childbearing potential

    Exclusion Criteria:

    • Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs

    • Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young

    • Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy

    • Have known allergies to GLP-1 receptor agonists

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pinnacle Research Group, LLC Anniston Alabama United States 36207
    2 CenExcel ACT Anaheim California United States 92801
    3 Qps-Mra, Llc South Miami Florida United States 33143
    4 Hassman Research Institute Berlin New Jersey United States 08009

    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

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05377333
    Other Study ID Numbers:
    • 18129
    • J1R-MC-GZFB
    First Posted:
    May 17, 2022
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 9, 2022
    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:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Dulaglutide

    Study Results

    No Results Posted as of Jun 27, 2022