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

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What is this study about?

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.

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.

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).

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.

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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
InnoDiab Forschung GmbH Essen Germany
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. Cracow Poland
Velocity Clinical Research Leipzig GmbH Leipzig Germany
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
Ecinjk Sma z orzm Lublin Poland
Czifowf Bjcjs Kodfdrszpnn Pyamimjm Ssl z ompw Gdansk Poland
Gdeuoxjuzpdqmugxbqi Dzt Tjpknopkg / Dgh Batfzac Leipzig Germany
Setijrv Cvjmrhfmghcao Sch z oyky Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
15.07.2025
Poland Poland
Recruiting
15.07.2025

Trial locations

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.

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.

Trial ID:
2024-520328-27-00
Protocol code:
J1R-MC-GZFD
Trial Phase:
Therapeutic exploratory (Phase II)

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