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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: LY3457263; Drug: Dulaglutide

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
  • California
    • Anaheim, California, United States, 92801
      • CenExel ACT
  • Florida
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc
  • Georgia
    • Atlanta, Georgia, United States, 30331 2012
      • Atlanta Center of Medical Research
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • CenExel-HRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Predose up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263	PK: AUC of LY3457263	Pre-dose on Day 1 up to 85 days post-dose

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: 18129; J1R-MC-GZFB (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