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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: LY3457263; Drug: Dulaglutide

• Registration Number: NCT05377333
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-17
• Study Start: 2022-06-02
• Primary Completion: 2023-11-22
• Study Completion: 2023-11-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Alone)	Placebo	Placebo administered SC.
LY3457263 (Alone)	LY3457263	LY3457263 administered subcutaneously (SC).
LY3457263 + Dulaglutide	LY3457263	LY3457263 in combination with dulaglutide administered SC.
Placebo + Dulaglutide	Placebo	Placebo in combination with dulaglutide administered SC.
LY3457263 + Dulaglutide	Dulaglutide	LY3457263 in combination with dulaglutide administered SC.
Placebo + Dulaglutide	Dulaglutide	Placebo in combination with dulaglutide administered SC.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States

CenExel-HRI; 🇺🇸 Berlin, New Jersey, United States

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

CenExel ACT; 🇺🇸 Anaheim, California, United States

Atlanta Center of Medical Research; 🇺🇸 Atlanta, Georgia, United States