Clinical trial NCT06897475: A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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:

  * 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 another oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the additional 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 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

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 24
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Helios Clinical Research - Phoenix
state: Arizona
city: Tustin
country: United States
facility: Wolverine Clinical Trials
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research
state: Florida
city: Lawrenceville
country: United States
facility: Balanced Life Health Care Solutions/SKYCRNG
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Rexburg
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Brownsburg
country: United States
facility: Investigators Research Group
state: Indiana
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group
state: New York
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Shelby
country: United States
facility: Shelby Clinical Research
state: North Carolina
city: Dayton
country: United States
facility: Providence Health Partners-Center for Clinical Research
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Moncton
country: Canada
facility: G A Research Associates
state: New Brunswick
city: Brampton
country: Canada
facility: Centricity Research Brampton Endocrinology
state: Ontario
city: Hamilton
country: Canada
facility: Winterberry Research Inc.
state: Ontario
city: Oshawa
country: Canada
facility: Private Practice - Dr. James Cha
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research
state: Ontario
city: Toronto
country: Canada
facility: Diabetes Heart Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: Fadia El Boreky Medicine
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Greenfield Park
country: Canada
facility: Viacar Recherche Clinique
state: Quebec
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Velocity Clinical Research, Leipzig
state: Sachsen
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
state: Dolnośląskie
city: Lublin
country: Poland
facility: Ekamed
state: Lubelskie
city: Warszawa
country: Poland
facility: NBR Polska
state: Mazowieckie
city: Warszawa
country: Poland
facility: Szpital Czerniakowski
state: Mazowieckie
city: Krakow
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
state: Małopolskie
city: Tarnów
country: Poland
facility: Private Practice - Dr. Robert Witek
state: Małopolskie
city: Bialystok
country: Poland
facility: Legeartis - Poradnie Specjalistyczne
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Bayamon
country: Puerto Rico
facility: Centro de Endocrinologia Alcantara Gonzalez
city: San Juan
country: Puerto Rico
facility: Mgcendo Llc
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: Bristol, City Of
city: Newquay
country: United Kingdom
facility: Newquay Health Centre
state: Cornwall
city: Torpoint
country: United Kingdom
facility: Rame Group Practice
state: Cornwall
city: Poole
country: United Kingdom
facility: The Adam Practice
state: Dorset
city: Newcastle
country: United Kingdom
facility: Futuremeds-Newcastle
state: England
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
state: Lancashire
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital
state: Warwickshire
city: Bromborough
country: United Kingdom
facility: FutureMeds - Liverpool
state: Wirral
city: Birmingham
country: United Kingdom
facility: FutureMeds - Birmingham
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: