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COMPLETED
NCT06109311
PHASE3

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Official title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

546

Start Date

2023-11-10

Completion Date

2025-09-15

Last Updated

2026-10-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Orforglipron

Administered orally.

DRUG

Placebo

Administered orally.

Locations (70)

MD First Research - Chandler

Chandler, Arizona, United States

Phoenix Clinical LLC

Phoenix, Arizona, United States

SanRo Clinical Research Group

Bryant, Arkansas, United States

Velocity Clinical Research, Gardena

Gardena, California, United States

Loma Linda University Health System

Loma Linda, California, United States

Western University of Health Sciences

Pomona, California, United States

Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.

Toluca Lake, California, United States

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Care Access - Brandon

Brandon, Florida, United States

Encore Medical Research

Hollywood, Florida, United States

Encore Medical Research - Weston

Weston, Florida, United States

Orita Clinical Research

Decatur, Georgia, United States

Bingham Memorial Hospital

Blackfoot, Idaho, United States

St. Luke's Humphreys Diabetes Center: Boise

Boise, Idaho, United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

The Research Group of Lexington

Lexington, Kentucky, United States

Clinvest Headlands Llc

Springfield, Missouri, United States

Richmond University Medical Center

Staten Island, New York, United States

Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Tristar Clinical Investigations

Philadelphia, Pennsylvania, United States

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, United States

Lifedoc Research - Lenox Park Drive

Memphis, Tennessee, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Texas Valley Clinical Research

Weslaco, Texas, United States

CEDOES

Vitória, Espírito Santo, Brazil

L2IP - Instituto de Pesquisas Clínicas

Brasília, Federal District, Brazil

Quanta Diagnóstico e Terapia

Curitiba, Paraná, Brazil

Insight Centro de Pesquisas

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, Brazil

Centro Multidisciplinar de Estudos Clinicos

São Bernardo do Campo, São Paulo, Brazil

ISPEM - Instituto São José dos Campos em Pesquisas Médicas

São José dos Campos, São Paulo, Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, Brazil

CPQuali Pesquisa Clínica

São Paulo, Brazil

The Second People's Hospital of Hefei

Hefei, Anhui, China

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Henan, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Jinan Central Hospital

Jinan, Shandong, China

Tokuyama Clinic

Mihama-ku,Chiba City, Chiba, Japan

Hasegawa Medical Clinic

Chitose, Hokkaido, Japan

MinamiAkatsukaClinic

Mito, Ibaraki, Japan

Matoba Internal Medicine Clinic

Ebina, Kanagawa, Japan

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, Japan

Shiraiwa Medical Clinic

Kashihara, Osaka, Japan

The Institute of Medical Science, Asahi Life Foundation

Chuo-ku, Tokyo, Japan

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Medical Corporation Sato Medical clinic

Ootaku, Tokyo, Japan

Tama Center Clinic Mirai

Tama, Tokyo, Japan

Jinnouchi Hospital

Kumamoto, Japan

Kansai Electric Power Hospital

Osaka, Japan

Abe Clinic

Ōita, Japan

Centro de Endocrinologia y Nutricion

Caguas, Puerto Rico

FDI Clinical Research

San Juan, Puerto Rico

Diabdana

Oradea, Bihor County, Romania

C.M.D.T.A. Neomed

Brasov, Brașov County, Romania

Geea Medical Easy Diet

Bucharest, Bucharest, Romania

Centrul Medical NutriLife

Bucharest, Bucharest, Romania

Centrul Medical Endocrinologie si Diabet Dr. Paveliu

Bucharest, Bucharest, Romania

CMI DNBM Dr. Pop Lavinia

Baia Mare, Maramureş, Romania

SC Dentosim Queen SRL - Centrul Medical Diamed

Târgu Mureş, Mureș County, Romania

Milena Sante

Galați, Romania

Diamed Obesity

Galați, Romania

Clinica Korall

Satu Mare, Romania