Clinical trial NCT05377333: A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Predose up to 16 weeks
Secondary outcomes:
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263
timeFrame: Pre-dose on Day 1 up to 85 days post-dose
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Anaheim
country: United States
facility: CenExel ACT
state: California
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center of Medical Research
state: Georgia
city: Berlin
country: United States
facility: CenExel-HRI
state: New Jersey
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: