Recruiting NCT06897475
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY3457263, Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Germany, Poland, Puerto Rico +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug LY3457263
Administered SC - Drug Placebo
Administered SC
Primary outcome measures
- Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 24]
Secondary outcome measures (2)
- Change from Baseline in Fasting Serum Glucose [Time frame: Baseline, Week 24]
- Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 24]
Eligibility criteria
Inclusion criteria
- Have type 2 diabetes
- Have HbA1c ≥7.5% to ≤10.5% at screening
- Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
- Have had a stable body weight for the three months prior to screening
- On stable treatment dose of one of the following incretins for at least three months prior to screening:
- Injectable semaglutide (1 and 2 milligram (mg))
- Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)
Exclusion criteria
- Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
- Have a prior or planned surgical treatment for obesity
- Have any of the following cardiovascular conditions within three months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure
- Have used insulin to control blood glucose within the past year (short-term use allowed)
- Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening
- If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
- Have taken any medications or alternative remedies for weight loss within three months prior to screening
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 25 centers
- Helios Clinical Research - Phoenix — Phoenix
- Wolverine Clinical Trials — Santa Ana
- Renstar Medical Research — Ocala
- Oviedo Medical Research — Oviedo
- Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville
- Physicians Research Associates — Lawrenceville
- Rophe Adult and Pediatric Medicine/SKYCRNG — Union City
- North Georgia Clinical Research — Woodstock
- … and 17 more centers
United Kingdom · 10 centers
- FutureMeds - Birmingham — Birmingham
- Layton Medical Centre — Blackpool
- Southmead Hospital — Bristol
- FutureMeds - Liverpool — Bromborough
- Futuremeds-Newcastle — Newcastle
- Newquay Health Centre — Newquay
- George Eliot Hospital — Nuneaton
- The Adam Practice — Poole
- … and 2 more centers
Canada · 9 centers
- Centricity Research Brampton Endocrinology — Brampton
- Ecogene-21 — Chicoutimi
- Winterberry Research Inc. — Hamilton
- Viacar Recherche Clinique — Longueuil
- G A Research Associates — Moncton
- Bluewater Clinical Research Group Inc. — Sarnia
- Maple Leaf Research — Toronto
- Diabetes Heart Research Centre — Toronto
- … and 1 more center
Poland · 9 centers
- Legeartis - Poradnie Specjalistyczne — Bialystok
- Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
- Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET — Krakow
- Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna — Lodz
- Ekamed — Lublin
- Private Practice - Dr. Robert Witek — Tarnów
- NBR Polska — Warsaw
- Szpital Czerniakowski — Warsaw
- … and 1 more center
Germany · 5 centers
- InnoDiab Forschung Gmbh — Essen
- Velocity Clinical Research, Leipzig — Leipzig
- Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut — Leipzig
- Institut für Diabetesforschung GmbH Münster — Münster
- RED-Institut GmbH — Oldenburg
Puerto Rico · 2 centers
- Centro de Endocrinologia Alcantara Gonzalez — Bayamón
- Mgcendo Llc — San Juan
Identifiers
NCT: NCT06897475 · 27344 · 2024-520328-27-00 · J1R-MC-GZFD