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Completed

NCT Number: NCT05377333

A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3457263

Drug

Administered SC.

Placebo

Drug

Administered SC.

Dulaglutide

Drug

Administered SC.

Other names: LY2189265

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

    Time frame: 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 outcomes

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

    Time frame: Pre-dose on Day 1 up to 85 days post-dose

    PK: AUC of LY3457263

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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