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

NCT05377333 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18129J1R-MC-GZFB
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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

  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 Outcomes (1)

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263

  Pre-dose on Day 1 up to 85 days post-dose

Study Arms (4)

LY3457263 (Alone)

EXPERIMENTAL

LY3457263 administered subcutaneously (SC).

Drug: LY3457263

Placebo (Alone)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

LY3457263 + Dulaglutide

EXPERIMENTAL

LY3457263 in combination with dulaglutide administered SC.

Drug: LY3457263; Drug: Dulaglutide

Placebo + Dulaglutide

EXPERIMENTAL

Placebo in combination with dulaglutide administered SC.

Drug: Placebo; Drug: Dulaglutide

Interventions

LY3457263 DRUG

Administered SC.

LY3457263 (Alone); LY3457263 + Dulaglutide

Placebo DRUG

Administered SC.

Placebo (Alone); Placebo + Dulaglutide

Dulaglutide DRUG

Administered SC.

Also known as: LY2189265

LY3457263 + Dulaglutide; Placebo + Dulaglutide

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

CenExel ACT

Anaheim, California, 92801, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Atlanta Center of Medical Research

Atlanta, Georgia, 30331 2012, United States

Location

CenExel-HRI

Berlin, New Jersey, 08009, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 17, 2022
• Study Start: June 2, 2022
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)