A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
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Voluntary — you can stop anytime
What is this study?
The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Have type 2 diabetes
- •HbA1c between 7.5% and 10.5% at screening (HbA1c is a blood test that shows average blood sugar over time)
- •BMI of at least 27 at screening (BMI is a body-size measure)
- •Have had steady body weight for the 3 months before screening
- •Taking a stable dose of injectable semaglutide or tirzepatide for at least 3 months before screening
🚫 You may not be able to join if…
- •Have type 1 diabetes, latent autoimmune diabetes, or a history of ketoacidosis or hyperosmolar coma
- •Have had or plan weight-loss surgery
- •Had certain heart or blood-vessel problems within 3 months before screening (including heart attack, stroke, unstable angina, or being hospitalized for congestive heart failure)
- •Used insulin to control blood sugar within the past year (short-term use is allowed)
- •Used certain diabetes medicines or weight-loss medicines too recently (and the study lists which are allowed if stopped early enough)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults with type 2 diabetes
- ✓HbA1c between 7.5% and 10.5% at screening
- ✓BMI 27 or higher
- ✓Currently on a stable semaglutide or tirzepatide dose for at least 3 months
- ✓Weight has been stable for 3 months before screening
- ✓No recent major heart/brain events or certain diabetes complications/history
- !Some conditions may not be a fit: Heart / cardiovascular disease
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- •Some participants receive a . The study team tells you your chances of getting the active treatment before you decide.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 4 groups in this study.
What to expect, step by step
· This study lasts about 24 weeks (~6 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 24 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: LY3457263
- Drug: Placebo
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Eli Lilly and Company
Overseen by Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06897475 · Locations: Arizona · California · Florida · Georgia · Idaho · Indiana · New Jersey · New York · North Carolina · Ohio · Oklahoma · Pennsylvania · Texas · Washington