Type 2 Diabetes Clinical Trial
— ACHIEVE-3Official title:
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)
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.
| Status | Recruiting |
| Enrollment | 1576 |
| Est. completion date | July 25, 2025 |
| Est. primary completion date | July 25, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Médico Viamonte | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | CIPREC | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Instituto Centenario | Caba | Ciudad Autónoma De Buenos Aires |
| Argentina | Consultorio de Investigación Clínica EMO SRL | Ciudad Autonoma de Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aires | Buenos Aires |
| Argentina | Instituto de Investigaciones Clínicas Córdoba | Córdoba | |
| Argentina | Instituto Médico DAMIC | Córdoba | |
| Argentina | CIMeL Clinical Research | Lanus | 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 | Fundacion Estudios Clinicos | Rosario | Santa Fe |
| Argentina | INECO Neurociencias Oroño | Rosario | Santa Fe |
| Argentina | Instituto de Especialidades de la Salud Rosario | Rosario | Santa Fe |
| Argentina | Instituto Médico Catamarca IMEC | Rosario | Santa Fe |
| Argentina | Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Rosario | Santa Fe |
| Argentina | Centro de Salud e Investigaciones Médicas | Santa Rosa | La Pampa |
| Argentina | Sanatorio Norte | Santiago del Estero | |
| China | Beijing Pinggu District Hospital | Beijing | Beijing |
| China | West China Hospital of Sichuan University | ChengDu | Sichuan |
| China | Chongqing General Hospital | Chongqing | Chongqing |
| China | Dalian Municipal Central Hospital Affiliated of Dalian Medical University | Dalian | Liaoning |
| China | Shunde Hospital of Southern Medical Univesity | Foshan | Guangdong |
| China | Zhejiang Hospital | Hangzhou | Zhejiang |
| China | The Fourth Hospital of Harbin Medical University | Harbin | Heilongjiang |
| China | Huizhou Municipal Central Hospital | Huizhou | Guangdong |
| China | Huzhou Central Hospital | Huzhou | Zhejiang |
| China | Jinan Central Hospital | Jinan | Shandong |
| China | First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan |
| China | The First Affiliated Hospital of Henan University of Science &Technology | Luoyang Shi | Henan |
| China | Nanjing First Hospital | Nanjing | Jiangsu |
| China | The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
| China | Nanyang First People's Hospital | Nanyang | Henan |
| China | Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi |
| China | Pudong New Area People's Hospital Shanghai | Shanghai | Shanghai |
| China | Shanghai Sixth People's Hospital | Shanghai | Shanghai |
| China | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
| China | The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
| China | Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu |
| Japan | Gifu University Hospital | Gifu | |
| Japan | Takai Internal Medicine Clinic | Kamakura-shi | Kanagawa |
| Japan | Shiraiwa Medical Clinic | Kashiwara | Osaka |
| Japan | Mikannohana Clinic, Diabetes, Endocrinology and Metabolism | Matsuyama | Ehime |
| Japan | Nakamoto Internal Medicine Clinic | Mito | Ibaraki |
| Japan | Nakakinen clinic | Naka | Ibaraki |
| Japan | Medical Corporation Sato Medical clinic | Ootaku | Tokyo |
| Japan | Manda Memorial Hospital | Sapporo | Hokkaido |
| Japan | Ohishi Internal Medicine Clinic | Tsuchiura | Ibaraki |
| Mexico | Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. | Culiacan | Sinaloa |
| Mexico | Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia | Durango | |
| Mexico | Centro de Investigacion Medica Integral | Guadalajara | Jalisco |
| Mexico | CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C | Guadalajara | Jalisco |
| Mexico | Consultorio Médico | Guadalajara | Jalisco |
| Mexico | Instituto Jalisciense de Investigacion en Diabetes y Obesidad | Guadalajara | Jalisco |
| Mexico | Private Practice - Dr. Arechavaleta Granell Maria del Rosario | Guadalajara | Jalisco |
| Mexico | Virgen Cardiovascular Research SC | Guadalajara | Jalisco |
| Mexico | CAIMED México | Mexico City | Distrito Federal |
| Mexico | Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares | Mexico City | Distrito Federal |
| Mexico | Cardiolink Clin Trials | Monterrey | Nuevo León |
| Mexico | Clínica García Flores SC | Monterrey | Nuevo León |
| Mexico | Eukarya PharmaSite | Monterrey | Nuevo León |
| Mexico | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León |
| Mexico | Unidad biomedica avanzada monterrey | Monterrey | Nuevo León |
| Mexico | Centro de investigación y control metabólico | San Nicolás de los Garza | Nuevo León |
| Mexico | Centro de Investigacion Medica de Occidente, S.C. | Zapopan | Jalisco |
| Puerto Rico | Private Practice - Dr. Paola Mansilla-Letelier | Guaynabo | |
| Puerto Rico | Research and Cardiovascular Corp. | Ponce | |
| Puerto Rico | Endocrinologist Metabolic Clinic & Research Institute | San Juan | |
| Puerto Rico | Latin Clinical Trial Center | San Juan | |
| United States | Albany Medical College, Division of Community Endocrinology | Albany | New York |
| United States | Velocity Clinical Research, Austin | Austin | Texas |
| United States | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania |
| United States | Northwest Clinical Trials | Boise | Idaho |
| United States | Joslin Diabetes Center | Boston | Massachusetts |
| United States | Ellipsis Research Group | Brooklyn | New York |
| United States | San Fernando Valley Health Institute | Canoga Park | California |
| United States | Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida |
| United States | Aventiv Research Inc | Columbus | Ohio |
| United States | The Corvallis Clinic, P.C. | Corvallis | Oregon |
| United States | Connecticut Clinical Research - Cromwell | Cromwell | Connecticut |
| United States | Dallas Diabetes Research Center | Dallas | Texas |
| United States | Revival Research Institute - Dearborn | Dearborn | Michigan |
| United States | Neighborhood Healthcare Institute of Health | Escondido | California |
| United States | Diabetes and Thyroid Center of Ft. Worth | Fort Worth | Texas |
| United States | Velocity Clinical Research, Gardena | Gardena | California |
| United States | New West Physicians Clinical Research | Golden | Colorado |
| United States | American Health Network of IN, LLC | Greenfield | Indiana |
| United States | PharmQuest | Greensboro | North Carolina |
| United States | The Research Center of The Upstate | Greenville | South Carolina |
| United States | Clear Brook Medical Associates | Houston | Texas |
| United States | Endocrine Ips, Pllc | Houston | Texas |
| United States | Juno Research | Houston | Texas |
| United States | Family First Medical Center | Idaho Falls | Idaho |
| United States | Glacier View Research Institute - Endocrinology | Kalispell | Montana |
| United States | Kansas City Research Institute | Kansas City | Missouri |
| United States | New Phase Research and Development | Knoxville | Tennessee |
| United States | Wr-Crcn, Llc | Las Vegas | Nevada |
| United States | Balanced Life Health Care Solutions/SKYCRNG | Lawrenceville | Georgia |
| United States | Biopharma Informatic | Los Angeles | California |
| United States | National Research Institute - Wilshire | Los Angeles | California |
| United States | South Florida Clinical Research Institute | Margate | Florida |
| United States | Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee |
| United States | Southern Endocrinology Associates | Mesquite | Texas |
| United States | Miami Dade Medical Research Institute, LLC | Miami | Florida |
| United States | Tekton Research, Inc | Moore | Oklahoma |
| United States | Lucas Research, Inc | Morehead City | North Carolina |
| United States | DelRicht Research | New Orleans | Louisiana |
| United States | Infinity Clinical Research - Norco | Norco | California |
| United States | Intend Research, LLC | Norman | Oklahoma |
| United States | Valley Clinical Trials, Inc. | Northridge | California |
| United States | West Orange Endocrinology | Ocoee | Florida |
| United States | Absolute Clinical Research | Phoenix | Arizona |
| United States | Office 18 | Pittsburgh | Pennsylvania |
| United States | Eastside Research Associates | Redmond | Washington |
| United States | Rainier Clinical Research Center | Renton | Washington |
| United States | SKY Clinical Research Network Group-Quinn | Ridgeland | Mississippi |
| United States | Synexus Clinical Research US, Inc. | Salt Lake City | Utah |
| United States | Norcal Endocrinology & Internal Medicine | San Ramon | California |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | Accellacare - Piedmont | Statesville | North Carolina |
| United States | Clinical Research Atlanta | Stockbridge | Georgia |
| United States | Latin Clinical Trial Center Florida | Tamarac | Florida |
| United States | Clinical Research of West Florida | Tampa | Florida |
| United States | Cotton O'Neil Clinical Research Center | Topeka | Kansas |
| United States | Premier Research | Trenton | New Jersey |
| United States | University Clinical Investigators, Inc. | Tustin | California |
| United States | Velocity Clinical Research, Valparaiso | Valparaiso | Indiana |
| United States | Texas Valley Clinical Research | Weslaco | Texas |
| United States | Metabolic Research Institute, Inc. | West Palm Beach | Florida |
| United States | Great Lakes Medical Research, LLC | Westfield | New York |
| United States | Tekton Research - Wichita | Wichita | Kansas |
| United States | Wake Forest University Baptist Medical Center (WFUBMC) | Winston-Salem | North Carolina |
| United States | North Georgia Clinical Research | Woodstock | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, China, Japan, Mexico, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 52 | ||
| Secondary | Change from Baseline in HbA1c | Baseline, Week 52 | ||
| Secondary | Percentage of Participants Who Achieved HbA1c <7.0% 53 millimole/mole (mmol/mol) | Week 52 | ||
| Secondary | Percentage of Participants Who Achieved HbA1c =6.5% (48 mmol/mol) | Week 52 | ||
| Secondary | Percentage Change from Baseline in Body Weight | Baseline, Week 52 | ||
| Secondary | Change from Baseline in Body Weight | Baseline, Week 52 | ||
| Secondary | Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/mol) | Week 52 | ||
| Secondary | Change from Baseline in Fasting Serum Glucose | Baseline, Week 52 | ||
| Secondary | Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG) | Baseline, Week 52 | ||
| Secondary | Percentage of Participants Who Achieved Weight Loss of =5% | Week 52 | ||
| Secondary | Percentage of Participants Who Achieved Weight Loss of =10% | Week 52 | ||
| Secondary | Percentage of Participants Who Achieved Weight Loss of =15% | Week 52 | ||
| Secondary | Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 52 | ||
| Secondary | Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 52 | ||
| Secondary | Percentage Change from Baseline in Total Cholesterol | Baseline, Week 52 | ||
| Secondary | Percentage Change from Baseline in High Density Lipoprotein (HDL)-Cholesterol | Baseline, Week 52 | ||
| Secondary | Percentage Change from Baseline in Low Density Lipoprotein (LDL)-Cholesterol | Baseline, Week 52 | ||
| Secondary | Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-Cholesterol | Baseline, Week 52 | ||
| Secondary | Percentage Change from Baseline in Non-HDL-Cholesterol | Baseline, Week 52 | ||
| Secondary | Percentage Change from Baseline in Triglycerides | Baseline, Week 52 | ||
| Secondary | Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores | Baseline, Week 52 |
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