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Study of LY3457263 compared to placebo in adults with type 2 diabetes who are taking semaglutide or tirzepatide but have not reached their blood sugar goals

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Type 2 Diabetes who are currently using either semaglutide or tirzepatide injections but have not achieved their desired blood sugar control. The study will test a new medication called LY3457263 (also known as nisotirotide) to see if it can help lower blood sugar levels when added to current treatment.

The study medication or placebo will be given as an injection under the skin (subcutaneous injection) once per week. The study will compare how well LY3457263 works compared to placebo in controlling blood sugar levels, specifically by measuring HbA1c (a measure of average blood sugar over the past 2-3 months).

Participants will receive either the study medication or placebo for 24 weeks. During this time, they will continue their regular diabetes medication (semaglutide or tirzepatide). The study will involve people who are overweight or have obesity and whose body weight has been stable for at least three months.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial phase
After qualifying for the study, you will be assigned to receive either LY3457263 or placebo (an inactive substance).
You will continue taking your current medication (semaglutide or tirzepatide) throughout the study.
Step 2
Treatment administration
You will receive weekly injections under the skin (subcutaneous injections).
The medication will be provided in pre-filled syringes for your convenience.
These injections will continue for 24 weeks (approximately 6 months).
Step 3
Monitoring period
Your blood sugar levels will be monitored through a test called HbA1c (a measure of average blood sugar over the past 2-3 months).
The main measurement of the study will compare your HbA1c levels at the start of the study to your levels after 24 weeks.
Your body weight will be monitored throughout the study period.
Step 4
Study completion
The study will evaluate how well the new medication controls blood sugar compared to placebo after 24 weeks of treatment.
The entire study is expected to run from July 2025 through December 2026.

Who can join the trial?

6 criteria

You must be diagnosed with type 2 diabetes
You must have overweight or obesity (a body weight above what is considered healthy for your height)
Your body weight must have remained stable for 3 months before the initial screening visit
You must be currently using either injectable semaglutide (a medication that helps control blood sugar) or injectable tirzepatide (a medication that helps control blood sugar and may help with weight loss) at the same dose for at least 3 months
You can be either male or female
You must be an adult (18 years or older)

Who cannot join the trial?

15 criteria

History of type 1 diabetes or other types of diabetes besides type 2 diabetes
Current pregnancy or breastfeeding
Age below 18 years old
HbA1c (average blood sugar level over past 3 months) outside required range
Severe heart, kidney, or liver disease
Current participation in other clinical trials
History of severe allergic reactions to medications
Use of certain diabetes medications that could interfere with the study drug
Unstable blood pressure or other uncontrolled medical conditions
History of diabetic ketoacidosis (a serious complication where the body produces high levels of blood acids)
Major surgery within the past 3 months
Substance abuse or alcohol dependency
Mental health conditions that could affect study participation
Unable to follow study procedures or attend scheduled visits
History of cancer within the past 5 years (except certain skin cancers)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu
Wroclaw, Poland
Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Verified
Institut fuer Diabetesforschung Muenster GmbH
Munster, Germany

Trial locations

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Investigated drugs

LY3457263
is an investigational medication being studied for treating type 2 diabetes mellitus. It is given once weekly as an injection under the skin (subcutaneously). This medication is being tested to see if it can help lower blood sugar levels in patients who are not achieving their treatment goals.
Semaglutide
is a medication used to treat type 2 diabetes. It helps control blood sugar levels by helping the body produce more insulin when blood sugar is high and reducing the amount of sugar made by the liver. It is given as a weekly injection under the skin.
Tirzepatide
is a medication for type 2 diabetes that helps lower blood sugar levels. It works by helping the body release insulin and slowing down digestion. Like semaglutide, it is also given as a weekly injection under the skin.

Tirzepatide

What is already known about the treatment

LY3457263
An investigational injectable medication administered once weekly via subcutaneous injection, currently being studied in Phase 2 clinical trials for the treatment of Type 2 Diabetes Mellitus. This experimental drug is being evaluated in patients who are already on stable doses of semaglutide or tirzepatide but haven't achieved their target HbA1c levels. While the exact mechanism of action is still under investigation in clinical trials, it is being studied as a potential add-on therapy to enhance glycemic control in diabetic patients.
Semaglutide
A once-weekly injectable medication belonging to the GLP-1 receptor agonist class, approved for treating Type 2 Diabetes Mellitus. It works by mimicking the natural hormone GLP-1, which helps regulate blood sugar levels by stimulating insulin production, reducing glucagon secretion, and slowing down digestion. This medication helps lower blood sugar levels and may also contribute to weight loss as a secondary effect.
Tirzepatide
A dual GIP and GLP-1 receptor agonist administered as a once-weekly subcutaneous injection for the treatment of Type 2 Diabetes Mellitus. It works by activating both the GIP and GLP-1 receptors, which helps improve blood sugar control through multiple mechanisms including enhanced insulin secretion, reduced glucagon levels, and delayed gastric emptying. This medication is known for its powerful effects on both blood sugar control and weight management.

Investigated diseases

Type 2 Diabetes - A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition develops gradually, often beginning with insulin resistance, where body cells don't respond effectively to insulin. Over time, the pancreas may produce less insulin, leading to consistently elevated blood glucose levels. The condition typically appears in adults and is often associated with lifestyle factors and genetic predisposition. Type 2 diabetes can affect how the body processes carbohydrates, fats, and proteins, leading to various metabolic changes.