New diabetes pill takes on semaglutide in Head-to-Head trial

NCT ID NCT06045221

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This phase 3 study tested a new once-daily pill called orforglipron against an existing oral semaglutide in nearly 1,700 adults with type 2 diabetes whose blood sugar was not well controlled on metformin. The main goal was to see how well orforglipron lowers blood sugar levels over about 61 weeks. Researchers also looked at weight loss and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: orforglipron (LY3502970)
What this could lead to: If it works, this could offer a new once-daily pill option for type 2 diabetes that may lower blood sugar and help with weight loss.
What could go wrong: This is a completed phase 3 trial, but results are not yet published. Orforglipron may not prove better than semaglutide, and side effects like nausea or vomiting are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,698 people

The number who actually took part.

Started

Sep 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

Absolute Clinical Research

Phoenix, Arizona, 85051, United States
Accellacare - Piedmont

Statesville, North Carolina, 28625, United States
Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000, China
Albany Medical College, Division of Community Endocrinology

Albany, New York, 12203, United States
Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States
American Health Network of Indiana, LLC - Greenfield

Greenfield, Indiana, 46140, United States
Aventiv Research Inc

Columbus, Ohio, 43213, United States
Balanced Life Health Care Solutions/SKYCRNG

Lawrenceville, Georgia, 30046, United States
Beijing Pinggu District Hospital

Beijing, Beijing Municipality, 101200, China
Biopharma Informatic, LLC

Los Angeles, California, 90035, United States
CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C

Guadalajara, Jalisco, 44670, Mexico
CIMeL

Lanus, Buenos Aires, B1824KAJ, Argentina
CIPREC

Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina
Caimed Investigacion En Salud S.A. de C.V.

Mexico City, Mexico City, 06760, Mexico
Cardiolink Clin Trials

Monterrey, Nuevo León, 64060, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

Mexico City, Mexico City, 11650, Mexico
Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

Culiacán, Sinaloa, 80230, Mexico
Centro de Investigacion Medica Integral

Guadalajara, Jalisco, 44160, Mexico
Centro de Investigacion Medica de Occidente, S.C.

Zapopan, Jalisco, 44260, Mexico
Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina
Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, 7600, Argentina
Centro de Salud e Investigaciones Médicas

Santa Rosa, La Pampa Province, 6300, Argentina
Centro de investigación y control metabólico

San Nicolás de los Garza, Nuevo León, 66465, Mexico
Chongqing General Hospital

Chongqing, Chongqing Municipality, 400014, China
Clear Brook Medical Associates

Houston, Texas, 77089, United States
Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, 38119, United States
Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States
Clinical Research of West Florida

Tampa, Florida, 33606, United States
Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765, United States
Clínica García Flores SC

Monterrey, Nuevo León, 64610, Mexico
Connecticut Clinical Research - Cromwell

Cromwell, Connecticut, 06416, United States
Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., 1405, Argentina
Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States
Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, 116033, China
DelRicht Research

New Orleans, Louisiana, 70115, United States
Diabetes and Thyroid Center of Ft. Worth

Fort Worth, Texas, 76132, United States
Eastside Research Associates

Redmond, Washington, 98052, United States
Ellipsis Research Group - Brooklyn - 7th Street

Brooklyn, New York, 11215, United States
Encompass Clinical Research

Spring Valley, California, 91978, United States
Endocrine Ips, Pllc

Houston, Texas, 77079, United States
Eukarya PharmaSite

Monterrey, Nuevo León, 64718, Mexico
Family First Medical Center

Idaho Falls, Idaho, 83404, United States
First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China
Fundacion Estudios Clinicos

Rosario, Santa Fe Province, S2000DEJ, Argentina
Gifu University Hospital

Gifu, 501-1112, Japan
Great Lakes Medical Research, LLC

Westfield, New York, 14787, United States
Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, 15009, United States
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 66460, Mexico
Huizhou Municipal Central Hospital

Huizhou, Guangdong, 516001, China
Huzhou Central Hospital

Huzhou, Zhejiang, 313000, China
INECO Neurociencias Oroño

Rosario, Santa Fe Province, 2000, Argentina
Infinity Clinical Research - Norco

Norco, California, 92860, United States
Instituto Centenario

CABA, Buenos Aires F.D., 1204, Argentina
Instituto Jalisciense de Investigacion en Diabetes y Obesidad

Guadalajara, Jalisco, 44600, Mexico
Instituto Médico Catamarca IMEC

Rosario, Santa Fe Province, 2000, Argentina
Instituto Médico DAMIC

Córdoba, 5003DCE, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, Santa Fe Province, 2000, Argentina
Instituto de Especialidades de la Salud Rosario

Rosario, Santa Fe Province, 2000, Argentina
Instituto de Investigaciones Clínicas Córdoba

Córdoba, 5000, Argentina
Isis Clinical Research Center

Guaynabo, PR, 00968, Puerto Rico
Jiangxi Pingxiang People's Hospital

Pingxiang, Jiangxi, 337055, China
Jinan Central Hospital

Jinan, Shandong, 250013, China
Joslin Diabetes Center

Boston, Massachusetts, 02215, United States
Juno Research

Houston, Texas, 77040, United States
Kansas City Research Institute

Kansas City, Missouri, 64131, United States
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

Durango, 34000, Mexico
Latin Clinical Trial Center

San Juan, 00909, Puerto Rico
Latin Clinical Trial Center Florida

Tamarac, Florida, 33321, United States
Logan Health Research

Kalispell, Montana, 59901, United States
Lucas Research, Inc

Morehead City, North Carolina, 28557, United States
Manda Memorial Hospital

Sapporo, Hokkaido, 060-0062, Japan
Medical Corporation Sato Medical clinic

Ootaku, Tokyo, 143-0015, Japan
Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States
Mgcendo Llc

San Juan, PR, 00921, Puerto Rico
Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

Matsuyama, Ehime, 116099, Japan
Nakakinen clinic

Naka, Ibaraki, 311-0113, Japan
Nakamoto Internal Medicine Clinic

Mito, Ibaraki, 310-0826, Japan
Nanjing First Hospital

Nanjing, Jiangsu, 210006, China
Nanyang First People's Hospital

Nanyang, Henan, 473014, China
Neighborhood Healthcare Institute of Health

Escondido, California, 92025, United States
New Phase Research and Development

Knoxville, Tennessee, 37909, United States
New West Physicians Clinical Research

Golden, Colorado, 80401, United States
Norcal Endocrinology & Internal Medicine

San Ramon, California, 94583, United States
North Georgia Clinical Research

Woodstock, Georgia, 30189, United States
Northwest Clinical Trials

Boise, Idaho, 83704, United States
Ohishi Internal Medicine Clinic

Tsuchiura, Ibaraki, 300-0835, Japan
PharmQuest Life Sciences, LLC

Greensboro, North Carolina, 27408, United States
Policlinica Red OMIP

Mar del Plata, Buenos Aires, 7600, Argentina
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

Pittsburgh, Pennsylvania, 15236, United States
Premier Research

Trenton, New Jersey, 08611, United States
Private Practice - Dr. Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco, 44670, Mexico
Pudong New Area People's Hospital Shanghai

Shanghai, Shanghai Municipality, 201200, China
Rainier Clinical Research Center

Renton, Washington, 98057, United States
Research and Cardiovascular Corp.

Ponce, 00717, Puerto Rico
Revival Research Institute, LLC

Dearborn, Michigan, 48126, United States
SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States
San Fernando Valley Health Institute

Canoga Park, California, 91304, United States
Sanatorio Norte

Santiago del Estero, 4200, Argentina
Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200030, China
Shiraiwa Medical Clinic

Kashihara, Osaka, 582-0005, Japan
Shunde Hospital of Southern Medical Univesity

Foshan, Guangdong, 528399, China
South Florida Clinical Research Institute

Margate, Florida, 33063, United States
Southern Endocrinology Associates

Mesquite, Texas, 75149, United States
Synexus Clinical Research US, Inc.

Salt Lake City, Utah, 84106, United States
Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, 247-0056, Japan
Tekton Research, Inc

Wichita, Kansas, 67218, United States
Tekton Research, Inc

Moore, Oklahoma, 73160, United States
Texas Valley Clinical Research

Weslaco, Texas, 78596, United States
The Corvallis Clinic, P.C.

Corvallis, Oregon, 97330, United States
The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Henan, 471003, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China
The Research Center of The Upstate

Greenville, South Carolina, 29607, United States
The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China
The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China
Unidad biomedica avanzada monterrey

Monterrey, Nuevo León, 64460, Mexico
University Clinical Investigators, Inc.

Tustin, California, 92780, United States
Valley Clinical Trials, Inc.

Northridge, California, 91325, United States
Velocity Clinical Research, Austin

Austin, Texas, 78759, United States
Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States
Velocity Clinical Research, Gardena

Gardena, California, 90247, United States
Velocity Clinical Research, Valparaiso

Valparaiso, Indiana, 46383, United States
Velocity Clinical Research, Westlake

Los Angeles, California, 90057, United States
Virgen Cardiovascular Research SC

Guadalajara, Jalisco, 44670, Mexico
Wake Forest University Baptist Medical Center (WFUBMC)

Winston-Salem, North Carolina, 27104, United States
West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China
West Orange Endocrinology

Ocoee, Florida, 34761, United States
Wr-Crcn, Llc

Las Vegas, Nevada, 89106, United States
Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

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