NCT05377333CompletedPhase 1
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 11 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 16 May 2022
- Start date
- 2 Jun 2022
- Primary completion date
- 22 Nov 2023
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT05377333
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 94
- From 2 Jun 2022 to the primary completion date, 22 Nov 2023
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CenExel ACT Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Pinnacle Research Group, LLC Coordinator of this site? Confirm its status | Anniston | United States | Unknown status |
| Atlanta Center of Medical Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Cenexel HRI Coordinator of this site? Confirm its status | Berlin | United States | Unknown status |
| Qps-Mra, Llc Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.