A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: OrforglipronDrug: Semaglutide
- Registration Number
- NCT06045221
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1576
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 1 Orforglipron Participants will receive orforglipron orally. Orforglipron Dose 2 Orforglipron Participants will receive orforglipron orally. Semaglutide Dose 1 Semaglutide Participants will receive semaglutide orally. Semaglutide Dose 2 Semaglutide Participants will receive semaglutide orally.
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 52
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol) Week 52 Percentage Change from Baseline in Body Weight Baseline, Week 52 Change from Baseline in Body Weight Baseline, Week 52 Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/mol) Week 52 Change from Baseline in Fasting Serum Glucose Baseline, Week 52 Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG) Baseline, Week 52 Percentage of Participants Who Achieved Weight Loss of ≥5% Week 52 Change from Baseline in HbA1c Baseline, Week 52 Percentage of Participants Who Achieved HbA1c <7.0% 53 millimole/mole (mmol/mol) Week 52 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 52 Percentage of Participants Who Achieved Weight Loss of ≥10% Week 52 Percentage of Participants Who Achieved Weight Loss of ≥15% Week 52 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 52 Percentage Change from Baseline in Total Cholesterol Baseline, Week 52 Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-Cholesterol Baseline, Week 52 Percentage Change from Baseline in High Density Lipoprotein (HDL)-Cholesterol Baseline, Week 52 Percentage Change from Baseline in Low Density Lipoprotein (LDL)-Cholesterol Baseline, Week 52 Percentage Change from Baseline in Triglycerides Baseline, Week 52 Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores Baseline, Week 52 Percentage Change from Baseline in Non-HDL-Cholesterol Baseline, Week 52
Trial Locations
- Locations (130)
Caimed Investigacion En Salud S.A. de C.V.
🇲🇽Mexico City, Distrito Federal, Mexico
Absolute Clinical Research
🇺🇸Phoenix, Arizona, United States
San Fernando Valley Health Institute
🇺🇸Canoga Park, California, United States
Neighborhood Healthcare Institute of Health
🇺🇸Escondido, California, United States
Velocity Clinical Research, Gardena
🇺🇸Gardena, California, United States
Biopharma Informatic, LLC
🇺🇸Los Angeles, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Infinity Clinical Research - Norco
🇺🇸Norco, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
New West Physicians Clinical Research
🇺🇸Golden, Colorado, United States
Connecticut Clinical Research - Cromwell
🇺🇸Cromwell, Connecticut, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
South Florida Clinical Research Institute
🇺🇸Margate, Florida, United States
Miami Dade Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
Latin Clinical Trial Center Florida
🇺🇸Tamarac, Florida, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Balanced Life Health Care Solutions/SKYCRNG
🇺🇸Lawrenceville, Georgia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Family First Medical Center
🇺🇸Idaho Falls, Idaho, United States
American Health Network of Indiana, LLC - Greenfield
🇺🇸Greenfield, Indiana, United States
Velocity Clinical Research, Valparaiso
🇺🇸Valparaiso, Indiana, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
Tekton Research, Inc
🇺🇸Moore, Oklahoma, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Revival Research Institute, LLC
🇺🇸Dearborn, Michigan, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
Logan Health Research
🇺🇸Kalispell, Montana, United States
Wr-Crcn, Llc
🇺🇸Las Vegas, Nevada, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
Ellipsis Research Group - Brooklyn - 7th Street
🇺🇸Brooklyn, New York, United States
Albany Medical College, Division of Community Endocrinology
🇺🇸Albany, New York, United States
Great Lakes Medical Research, LLC
🇺🇸Westfield, New York, United States
PharmQuest Life Sciences, LLC
🇺🇸Greensboro, North Carolina, United States
Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
Accellacare - Piedmont
🇺🇸Statesville, North Carolina, United States
Wake Forest University Baptist Medical Center (WFUBMC)
🇺🇸Winston-Salem, North Carolina, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
The Corvallis Clinic, P.C.
🇺🇸Corvallis, Oregon, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
🇺🇸Pittsburgh, Pennsylvania, United States
The Research Center of The Upstate
🇺🇸Greenville, South Carolina, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Velocity Clinical Research, Austin
🇺🇸Austin, Texas, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Diabetes and Thyroid Center of Ft. Worth
🇺🇸Fort Worth, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Endocrine Ips, Pllc
🇺🇸Houston, Texas, United States
Clear Brook Medical Associates
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Texas Valley Clinical Research
🇺🇸Weslaco, Texas, United States
Synexus Clinical Research US, Inc.
🇺🇸Salt Lake City, Utah, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
CIMeL
🇦🇷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
CIPREC
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷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 Salud e Investigaciones Médicas
🇦🇷Santa Rosa, La Pampa, 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
Fundacion Estudios Clinicos
🇦🇷Rosario, Santa Fe, Argentina
Instituto de Investigaciones Clínicas Córdoba
🇦🇷Córdoba, Argentina
Instituto Médico DAMIC
🇦🇷Córdoba, Argentina
Sanatorio Norte
🇦🇷Santiago del Estero, Argentina
Beijing Pinggu District Hospital
🇨🇳Beijing, Beijing, China
Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
Shunde Hospital of Southern Medical Univesity
🇨🇳Foshan, Guangdong, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, Guangdong, China
The Fourth Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
Nanyang First People's Hospital
🇨🇳Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
Pudong New Area People's Hospital Shanghai
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳ChengDu, Sichuan, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
🇯🇵Matsuyama, Ehime, Japan
Manda Memorial Hospital
🇯🇵Sapporo, Hokkaido, Japan
Nakamoto Internal Medicine Clinic
🇯🇵Mito, Ibaraki, Japan
Nakakinen clinic
🇯🇵Naka, Ibaraki, Japan
Ohishi Internal Medicine Clinic
🇯🇵Tsuchiura, Ibaraki, Japan
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Shiraiwa Medical Clinic
🇯🇵Kashiwara, Osaka, Japan
Medical Corporation Sato Medical clinic
🇯🇵Ootaku, Tokyo, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
🇲🇽Mexico City, Distrito Federal, Mexico
Centro de Investigacion Medica Integral
🇲🇽Guadalajara, Jalisco, Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
🇲🇽Guadalajara, Jalisco, Mexico
CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C
🇲🇽Guadalajara, Jalisco, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
🇲🇽Guadalajara, Jalisco, Mexico
Virgen Cardiovascular Research SC
🇲🇽Guadalajara, Jalisco, Mexico
Centro de Investigacion Medica de Occidente, S.C.
🇲🇽Zapopan, Jalisco, Mexico
Cardiolink Clin Trials
🇲🇽Monterrey, Nuevo León, Mexico
Unidad biomedica avanzada monterrey
🇲🇽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
Centro de investigación y control metabólico
🇲🇽San Nicolás de los Garza, Nuevo León, 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
Isis Clinical Research Center
🇵🇷Guaynabo, Puerto Rico
Research and Cardiovascular Corp.
🇵🇷Ponce, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Mgcendo Llc
🇵🇷San Juan, Puerto Rico