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NCT05872620 | Active, not recruiting | Obesity


A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
Sponsor:

Eli Lilly and Company

Brief Summary:

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Condition or disease

Obesity

Overweight

Type 2 Diabetes

Intervention/treatment

Orforglipron

Placebo

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 1500 participants
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)
Actual Study Start Date : June 5, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025
Arm Intervention/treatment

Experimental: Orforglipron Dose 1

Participants will receive orforglipron administered orally.

Drug: Orforglipron

Experimental: Orforglipron Dose 2

Participants will receive orforglipron administered orally.

Drug: Orforglipron

Experimental: Orforglipron Dose 3

Participants will receive orforglipron administered orally.

Drug: Orforglipron

Placebo Comparator: Placebo

Participants will receive placebo

Drug: Placebo

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
  • Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of
    • either diet/exercise alone or
    • up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).
    Exclusion Criteria
    • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
    • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
    • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
    • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
    • Have had a history of chronic or acute pancreatitis.

A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Location Details


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A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Alabama

Cahaba Research - Pelham

Pelham, Alabama, United States, 35124

Not yet recruiting

United States, Arizona

Novak Clinical Research - Tucson - North La Cholla Boulevard

Tucson, Arizona, United States, 85741

Not yet recruiting

United States, Arizona

Yuma Clinical Trials

Yuma, Arizona, United States, 85364

Not yet recruiting

United States, California

AMCR Institute

Escondido, California, United States, 92025

Not yet recruiting

United States, California

National Research Institute - Huntington Park

Huntington Park, California, United States, 90255

Not yet recruiting

United States, California

National Research Institute - Wilshire

Los Angeles, California, United States, 90057

Not yet recruiting

United States, California

Catalina Research Institute, LLC

Montclair, California, United States, 91763

Not yet recruiting

United States, California

University Clinical Investigators, Inc.

Tustin, California, United States, 92780

Not yet recruiting

United States, Florida

Encore Medical Research

Hollywood, Florida, United States, 33021

Not yet recruiting

United States, Florida

East Coast Institute for Research, LLC

Jacksonville, Florida, United States, 32216

Not yet recruiting

United States, Florida

South Florida Clinical Research Institute

Margate, Florida, United States, 33063

Not yet recruiting

United States, Florida

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States, 34652

Not yet recruiting

United States, Georgia

Balanced Life Health Care Solutions/SKYCRNG

Lawrenceville, Georgia, United States, 30046

Not yet recruiting

United States, Georgia

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States, 30076

Not yet recruiting

United States, Georgia

North Georgia Clinical Research

Woodstock, Georgia, United States, 30189

Not yet recruiting

United States, Hawaii

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States, 96813

Not yet recruiting

United States, Idaho

Solaris Clinical Research

Meridian, Idaho, United States, 83646

Not yet recruiting

United States, Iowa

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States, 50265

Not yet recruiting

United States, Maryland

MedStar Good Samaritan Hospital

Baltimore, Maryland, United States, 21239

Not yet recruiting

United States, Michigan

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States, 48098

Not yet recruiting

United States, Missouri

StudyMetrix Research

Saint Peters, Missouri, United States, 63303

Not yet recruiting

United States, Nevada

Las Vegas Medical Research

Las Vegas, Nevada, United States, 89113

Not yet recruiting

United States, New Mexico

Albuquerque Neuroscience Inc.

Albuquerque, New Mexico, United States, 87109

Not yet recruiting

United States, New York

Albany Medical College, Division of Community Endocrinology

Albany, New York, United States, 12203

Not yet recruiting

United States, New York

Albany Stratton VA Medical Center

Albany, New York, United States, 12208

Not yet recruiting

United States, New York

NYC Research INC

Long Island City, New York, United States, 11106

Not yet recruiting

United States, North Carolina

Accellacare - Raleigh

Raleigh, North Carolina, United States, 27609

Not yet recruiting

United States, Oregon

Summit Headlands

Portland, Oregon, United States, 97210

Not yet recruiting

United States, Tennessee

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States, 37909

Not yet recruiting

United States, Texas

Dallas Diabetes Research Center

Dallas, Texas, United States, 75230

Not yet recruiting

United States, Texas

Soma Clinical Trials

Denison, Texas, United States, 75020

Not yet recruiting

United States, Texas

Epic Medical Research - DeSoto

DeSoto, Texas, United States, 75115

Not yet recruiting

United States, Texas

Biopharma Informatic, LLC

Houston, Texas, United States, 77043

Not yet recruiting

United States, Texas

Diabetes and Glandular Disease Center

San Antonio, Texas, United States, 78229

Not yet recruiting

United States, Texas

VIP Trials

San Antonio, Texas, United States, 78230

Not yet recruiting

United States, Virginia

Charlottesville Medical Research

Charlottesville, Virginia, United States, 22911

Not yet recruiting

United States, Washington

Universal Research Group

Tacoma, Washington, United States, 98405

Not yet recruiting

Argentina, Ciudad Aut

CEMEDIAB

C.a.b.a., Ciudad Aut, Argentina, C1205AAO

Not yet recruiting

Argentina, Ciudad Autónoma De Buenos Aires

Mautalen Salud e Investigación

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF

Not yet recruiting

Argentina, Ciudad Autónoma De Buenos Aire

Instituto Centenario

Caba, Ciudad Autónoma De Buenos Aire, Argentina, 1204

Not yet recruiting

Argentina, Santa Fe

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe, Argentina, 2000

Not yet recruiting

Argentina, Santa Fe

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, Santa Fe, Argentina, 2000

Not yet recruiting

Argentina, Santa Fe

Sanatorio San Martin

Venado Tuerto, Santa Fe, Argentina, 2600

Not yet recruiting

Argentina, Tucumán

Centro de Investigaciones Médicas Tucuman

SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL

Not yet recruiting

Argentina, New South Wales

CONEXA Investigacion Clinica S.A.

Buenos Aires, New South Wales, Argentina, 1012

Not yet recruiting

Argentina, New South Wales

Centro Diabetológico Dr. Waitman

Córdoba, New South Wales, Argentina, 5000

Not yet recruiting

Argentina, Queensland

Clínica Universitaria Reina Fabiola

Córdoba, Queensland, Argentina, X50004FHP

Not yet recruiting

Argentina, Queensland

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, Queensland, Argentina, 3000

Not yet recruiting

Australia, Queensland

Optimus Clinical Research

Botany, Queensland, Australia, 2019

Not yet recruiting

Australia, South Australia

The AIM Centre / Hunter Diabetes Centre

Merewether, South Australia, Australia, 2291

Not yet recruiting

Australia, Victoria

Royal Brisbane and Women's Hospital

Brisbane, Victoria, Australia, 4029

Not yet recruiting

Australia, Victoria

Core Research Group

Brisbane, Victoria, Australia, 4064

Not yet recruiting

Australia, Victoria

Logan Hospital

Meadowbrook, Victoria, Australia, 4131

Not yet recruiting

Australia, Victoria

Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, Victoria, Australia, 5046

Not yet recruiting

Australia, Western Australia

Box Hill Hospital

Box Hill, Western Australia, Australia, 3128

Not yet recruiting

Australia, Distrito Federal

Emeritus Research

Camberwell, Distrito Federal, Australia, 3124

Not yet recruiting

Australia, Goiás

Austin Health - Repatriation Hospital

Heidelberg West, Goiás, Australia, 3081

Not yet recruiting

Australia, Rio De Janeiro

Baker IDI Heart and Diabetes Institute - Melbourne

Melbourne, Rio De Janeiro, Australia, 3004

Not yet recruiting

Australia, Rio Grande Do Sul

GenesisCare

Joondalup, Rio Grande Do Sul, Australia, 6027

Not yet recruiting

Brazil, São Paulo

Centro de Pesquisa Clinica do Brasil

Brasilia, São Paulo, Brazil, 71625-175

Not yet recruiting

Brazil, São Paulo

Cendi - Endocrinologia e Diabetes

Goiânia, São Paulo, Brazil, 74230-035

Not yet recruiting

Brazil, São Paulo

Instituto Lóbus

Volta Redonda, São Paulo, Brazil, 27253-003

Not yet recruiting

Brazil, Anhui

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, Anhui, Brazil, 99010-120

Not yet recruiting

Brazil, Beijing

Instituto de Pesquisa clinica de Campinas

Campinas, Beijing, Brazil, 13060-080

Not yet recruiting

Brazil, Chongqing

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Chongqing, Brazil, 17504-072

Not yet recruiting

Brazil, Guangdong

Pesquisare Saude

Santo André, Guangdong, Brazil, 09080-110

Not yet recruiting

Brazil, Heilongjiang

Hospital das Clinicas FMUSP

São Paulo, Heilongjiang, Brazil, 04266-010

Not yet recruiting

China, Henan

The Second People's Hospital of Hefei

Hefei, Henan, China, 230011

Not yet recruiting

China, Henan

Chinese PLA General Hospital

Beijing, Henan, China, 100853

Not yet recruiting

China, Jiangsu

Chongqing General Hospital

Chongqing, Jiangsu, China, 400014

Not yet recruiting

China, Jiangsu

ShenZhen People's Hospital

Shenzhen, Jiangsu, China, 518020

Not yet recruiting

China, Jiangsu

The Fourth Hospital of Harbin Medical University

Harbin, Jiangsu, China, 150001

Not yet recruiting

China, Jiangsu

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Jiangsu, China, 471003

Not yet recruiting

China, Jiangsu

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Jiangsu, China, 450014

Not yet recruiting

China, Jiangxi

Nanjing First Hospital

Nanjing, Jiangxi, China, 210006

Not yet recruiting

China, Liaoning

Jiangsu Province Official Hospital

Nanjing, Liaoning, China, 210008

Not yet recruiting

China, Shandong

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Shandong, China, 210011

Not yet recruiting

China, Tianjin

Nantong First People's Hospital

Nantong, Tianjin, China, 226001

Not yet recruiting

China, Tianjin

Wuxi People's Hospital

Wuxi, Tianjin, China, 214023

Not yet recruiting

China, Yunnan

Jiangxi Provincial People's Hospital

Nanchang, Yunnan, China, 330006

Not yet recruiting

China, Jihočeský

Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Jihočeský, China, 116033

Not yet recruiting

China, Moravskosl

Jinan Central Hospital

Jinan, Moravskosl, China, 250013

Not yet recruiting

China, Pardubice

Tianjin Medical University General Hospital

Tianjin, Pardubice, China, 300052

Not yet recruiting

China, Plzeň-město

Tianjin Medical University Zhu Xianyi Memorial Hospital

Tianjin, Plzeň-město, China, 650034

Not yet recruiting

China, Praha 1

The First People's Hospital of Yunnan Province

Kunming, Praha 1, China, 37011

Not yet recruiting

Czechia, Praha 4

MUDr. Alena Vachova

Ceske Budejovice, Praha 4, Czechia, 79401

Not yet recruiting

Czechia, Praha 8

MUDr. Tomas Edelsberger

Krnov, Praha 8, Czechia, 530 02

Not yet recruiting

Czechia, Praha-západ

Diahelp s.r.o

Pardubice V, Praha-západ, Czechia, 301 00

Not yet recruiting

Czechia, Středočeský Kraj

Dialine - Interni a diabetologicka ambulance

Pilsen, Středočeský Kraj, Czechia, 11000

Not yet recruiting

Czechia, Bayern

Diabet2 s.r.o., diabetologicka a interni ambulance

Praha, Bayern, Czechia, 14900

Not yet recruiting

Czechia, Bayern

Milan Kvapil s.r.o., Diabetologicka ambulance

Praha, Bayern, Czechia, 18100

Not yet recruiting

Czechia, Hessen

ResTrial s.r.o.

Praha, Hessen, Czechia, 252 42

Not yet recruiting

Czechia, Nordrhein-Westfalen

MUDr. Sabina Palova

Jilove u Prahy, Nordrhein-Westfalen, Czechia, 26201

Not yet recruiting

Czechia, Nordrhein-Westfalen

Milan Kvapil s.r.o., Diabetologicka ambulance Pribram

Pribram, Nordrhein-Westfalen, Czechia, 500 12

Not yet recruiting

Czechia, Nordrhein-Westfalen

Endokrinologie MUDr. Rehorkova s.r.o.

Hradec Kralove, Nordrhein-Westfalen, Czechia, 326 00

Not yet recruiting

Czechia, Nordrhein-

MUDr. Jitka Zemanová - diabetologie a interna s.r.o.

Plzen, Nordrhein-, Czechia, 381 01

Not yet recruiting

Czechia, Sachsen-Anhalt

Nemocnice Cesky Krumlov

Český Krumlov, Sachsen-Anhalt, Czechia, 80809

Not yet recruiting

Germany, Sachsen-Anhalt

CDG Studienambulanz Hartard

München, Sachsen-Anhalt, Germany, 94574

Not yet recruiting

Germany, Sachsen

Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf

Wallerfing, Sachsen, Germany, 35415

Not yet recruiting

Germany, Sachsen

Diabetologische Schwerpunktpraxis Marck Linn Pickel

Pohlheim, Sachsen, Germany, 45136

Not yet recruiting

Germany, Schleswig-Holstein

InnoDiab Forschung Gmbh

Essen, Schleswig-Holstein, Germany, 45355

Not yet recruiting

Germany, Attikí

Medizentrum Essen Borbeck

Essen, Attikí, Germany, 50937

Not yet recruiting

Germany, Kentrikí Makedonía

University Hospital of Cologne

Köln, Kentrikí Makedonía, Germany, 48145

Not yet recruiting

Germany, Thessaloníki

Institut für Diabetesforschung GmbH Münster

Münster, Thessaloníki, Germany, 06679

Not yet recruiting

Germany, Thessaloníki

Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels

Hohenmölsen, Thessaloníki, Germany, 39120

Not yet recruiting

Germany, Thessaloníki

SMO.MD GmbH

Magdeburg, Thessaloníki, Germany, 04107

Not yet recruiting

Germany, Chhattisgarh

AmBeNet GmbH

Leipzig, Chhattisgarh, Germany, 01796

Not yet recruiting

Germany, Delhi

Private Practice - Dr. Christine Kosch

Pirna, Delhi, Germany, 23758

Not yet recruiting

Germany, Gujarat

RED-Institut GmbH

Oldenburg, Gujarat, Germany, 63571

Not yet recruiting

Germany, Karnataka

Diabetes Zentrum Dr. Tews

Gelnhausen, Karnataka, Germany, 21109

Not yet recruiting

Germany, Karnataka

Diabetes Zentrum Wilhelmsburg

Hamburg, Karnataka, Germany, 23562

Not yet recruiting

Germany, Madhya Pradesh

Universität zu Lübeck - Institut für Endokrinologie und Diabetes

Lübeck, Madhya Pradesh, Germany, 151 25

Not yet recruiting

Greece, Maharashtra

Athens Medical Center

Athens, Maharashtra, Greece, 54642

Not yet recruiting

Greece, Maharashtra

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Maharashtra, Greece, 546 45

Not yet recruiting

Greece, Maharashtra

Euromedica General Clinic of Thessaloniki

Thessaloniki, Maharashtra, Greece, 564 29

Not yet recruiting

Greece, Maharashtra

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Maharashtra, Greece, 570 01

Not yet recruiting

Greece, Tamil Nadu

Thermi Clinic

Thessaloniki, Tamil Nadu, Greece, 41110

Not yet recruiting

Greece, Telangana

University General Hospital of Larissa

Larissa, Telangana, Greece, 564 29

Not yet recruiting

Greece, Kang-won-do

424 Military General Training Hospital

Thessaloniki, Kang-won-do, Greece, 492099

Not yet recruiting

India, Kyǒnggi-do

All India Institute of Medical Sciences

Raipur, Kyǒnggi-do, India, 110005

Not yet recruiting

India, Kyǒngsangbuk-do

Dr B. L. Kapur Memorial Hospital

New Delhi, Kyǒngsangbuk-do, India, 388325

Not yet recruiting

India, Seoul-teukbyeolsi [Seoul]

Shree Krishna Hospital

Anand, Seoul-teukbyeolsi [Seoul], India, 560092

Not yet recruiting

India, Seoul-teukbyeolsi [Seoul]

Medstar Speciality Hospital

Bangalore, Seoul-teukbyeolsi [Seoul], India, 580021

Not yet recruiting

India, Seoul-teukbyeolsi [Seoul]

Karnataka Institute of Medical Sciences

Hubli, Seoul-teukbyeolsi [Seoul], India, 452010

Not yet recruiting

India,

TOTALL Diabetes Hormone Institute

Indore, India, 400008

Not yet recruiting

India,

Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

Mumbai, India, 400058

Not yet recruiting

India,

BSES MG Hospital

Mumbai, India, 441108

Not yet recruiting

India,

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, India, 411004

Not yet recruiting

India,

Sahyadri Super Speciality Hospital

Pune, India, 625020

Not yet recruiting

India,

Arthur Asirvatham Hospital

Madurai, India, 500072

Not yet recruiting

India,

Kumudini Devi Diabetes Research Center

Hyderabad, India, 26426

Not yet recruiting

Korea, Republic of,

Yonsei University-Wonju Severance Christian Hospital

Wonju, Korea, Republic of, 13620

Not yet recruiting

Korea, Republic of,

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of, 42415

Not yet recruiting

Korea, Republic of,

Yeungnam Univeristy Medical Center

Gyeongsan-si, Korea, Republic of, 02841

Not yet recruiting

Korea, Republic of,

Korea University Anam Hospital

Seoul, Korea, Republic of, 06591

Not yet recruiting

Korea, Republic of,

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 134-090

Not yet recruiting

Korea, Republic of,

Kyung Hee University Hospital at Gangdong

Seoul, Korea, Republic of, 00960

Not yet recruiting

Puerto Rico,

Advanced Clinical Research, LLC

Bayamón, Puerto Rico, 00970

Not yet recruiting

Puerto Rico,

Private Practice - Dr. Paola Mansilla-Letelier

Guaynabo, Puerto Rico,

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