GZFD LY3457263
Research type
Research Study
Full title
A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants with Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide who Failed to Achieve HbA1c Goal.
IRAS ID
1011791
Contact name
Tetiana Rudenok
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
A Study to Investigate HbA1c reduction with LY3457263 Compared with Placebo in Adult Participants with Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide.
Patients with Type 2 Diabetes Mellitus (T2DM) have above normal levels of glucose (sugar) in their blood. T2DM is associated with co-existing conditions such as obesity, hypertension, high cholesterol, and a higher risk of problems with the heart and blood vessels (that can lead to conditions such as heart attack or stroke). To help prevent diabetes related complications, in addition to addressing co-existing conditions as part of standard care, treatments are used to control the high levels of glucose in the blood.
This study will enrol adults (age 18 to 75 years) with T2DM who have been on a stable dose of either semaglutide or tirzepatide for at least 3 months and not achieved Haemoglobin A1C (HbA1c) goal. HbA1c is a blood test that measures a person’s average blood sugar level over the past two to three months.
The main purpose of this study is to learn more about nisotirostide, a possible new medicine for the treatment of T2DM. The study aims to learn whether nisotirostide, in combination with tirzepatide or semaglutide, can reduce HbA1c levels. Participants will be randomly assigned to nisotirostide or placebo (a placebo is an inactive or “pretend” study drug). Participation in the study is expected to last up to 40 weeks. Participants will have up to 12 clinic visits with the study doctor.
Approximately 200 participants will be enrolled in the study globally, including approximately 40 participants from the UK. The study will be ongoing for about 2 years.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0107
Date of REC Opinion
19 Jun 2025
REC opinion
Further Information Favourable Opinion