MedPath

A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Phase 3
Active, not recruiting
Conditions
Type 2 Diabetes
Interventions
Drug: Orforglipron
Drug: 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
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
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Orforglipron Dose 1OrforglipronParticipants will receive orforglipron orally.
Orforglipron Dose 2OrforglipronParticipants will receive orforglipron orally.
Semaglutide Dose 1SemaglutideParticipants will receive semaglutide orally.
Semaglutide Dose 2SemaglutideParticipants will receive semaglutide orally.
Primary Outcome Measures
NameTimeMethod
Change from Baseline in Hemoglobin A1c (HbA1c)Baseline, Week 52
Secondary Outcome Measures
NameTimeMethod
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)Week 52
Percentage Change from Baseline in Body WeightBaseline, Week 52
Change from Baseline in Body WeightBaseline, Week 52
Percentage of Participants Who Achieved HbA1c <5.7% (39 mmol/mol)Week 52
Change from Baseline in Fasting Serum GlucoseBaseline, 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 HbA1cBaseline, 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 CholesterolBaseline, Week 52
Percentage Change from Baseline in Very Low Density Lipoprotein (VLDL)-CholesterolBaseline, Week 52
Percentage Change from Baseline in High Density Lipoprotein (HDL)-CholesterolBaseline, Week 52
Percentage Change from Baseline in Low Density Lipoprotein (LDL)-CholesterolBaseline, Week 52
Percentage Change from Baseline in TriglyceridesBaseline, Week 52
Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary ScoresBaseline, Week 52
Percentage Change from Baseline in Non-HDL-CholesterolBaseline, 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

© Copyright 2025. All Rights Reserved by MedPath