A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3)

CompletadoFase 3ClinicalTrials.gov

ID: NCT06045221Tipo: INTERVENTIONALInicio: 22 de sept de 2023Fin estimado: 22 de ago de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have Type 2 Diabetes
Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening.
Have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization.
Are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment

Criterios de exclusión

Have Type 1 Diabetes
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
Have a New York Heart Association functional classification IV congestive heart failure.
Have an estimated glomerular filtration rate (eGFR) \<45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.

Intervenciones

drug

Orforglipron

Administered orally

drug

Semaglutide

Administered orally

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

CIMeL

Lanús, Buenos Aires, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Policlinica Red OMIP

Mar del Plata, Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., Argentina

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Centenario

CABA, Buenos Aires F.D., Argentina