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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377333
• Other study ID #: 18129
• Secondary ID: J1R-MC-GZFB
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2022
• Est. completion date: November 22, 2023

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 22, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3457263
Administered SC.
• Placebo
Administered SC.
• Dulaglutide
Administered SC.

Locations

Country	Name	City	State
United States	CenExel ACT	Anaheim	California
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Atlanta Center of Medical Research	Atlanta	Georgia
United States	CenExel-HRI	Berlin	New Jersey
United States	Qps-Mra, Llc	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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