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

Obesity Clinical Trial

— ATTAIN-2  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05872620
• Other study ID #: 18560
• Secondary ID: J2A-MC-GZGQ2022-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 5, 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes

Intervention

Drug:
• Orforglipron
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Argentina	CONEXA Investigacion Clinica S.A.	Buenos Aires
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CEMEDIAB	C.a.b.a.	Ciudad Aut
Argentina	Instituto Centenario	Caba	Ciudad Autónoma De Buenos Aire
Argentina	Centro Diabetológico Dr. Waitman	Córdoba
Argentina	Clínica Universitaria Reina Fabiola	Córdoba
Argentina	Instituto de Investigaciones Clinicas Rosario	Rosario	Santa Fe
Argentina	Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica	Rosario	Santa Fe
Argentina	Centro Medico Privado de Reumatologia	SAN M. DE Tucuman	Tucumán
Argentina	Centro de Diagnóstico y Rehabilitación (CEDIR)	Santa Fe
Argentina	Sanatorio San Martin	Venado Tuerto	Santa Fe
Australia	Optimus Clinical Research	Botany	New South Wales
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Core Research Group	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Emeritus Research	Camberwell	Victoria
Australia	Austin Health - Repatriation Hospital	Heidelberg West	Victoria
Australia	GenesisCare	Joondalup	Western Australia
Australia	Logan Hospital	Meadowbrook	Queensland
Australia	Baker IDI Heart and Diabetes Institute - Melbourne	Melbourne	Victoria
Australia	The AIM Centre / Hunter Diabetes Centre	Merewether	New South Wales
Australia	Southern Adelaide Diabetes & Endocrine Services	Oaklands Park	South Australia
Brazil	Centro de Pesquisa Clinica do Brasil	Brasilia	Distrito Federal
Brazil	Instituto de Pesquisa clinica de Campinas	Campinas	São Paulo
Brazil	Cendi - Endocrinologia e Diabetes	Goiânia	Goiás
Brazil	Centro de Pesquisa Clínica de Marília - CPCLIM	Marília	São Paulo
Brazil	Instituto Méderi de Pesquisa e Saúde	Passo Fundo	Rio Grande Do Sul
Brazil	Pesquisare Saude	Santo André	São Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	Instituto Lóbus	Volta Redonda	Rio De Janeiro
China	Chinese PLA General Hospital	Beijing	Beijing
China	Chongqing General Hospital	Chongqing	Chongqing
China	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second People's Hospital of Hefei	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Jiangsu Province Official Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Nantong First People's Hospital	Nantong	Jiangsu
China	ShenZhen People's Hospital	Shenzhen	Guangdong
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin Medical University Zhu Xianyi Memorial Hospital	Tianjin	Tianjin
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
Czechia	MUDr. Alena Vachova	Ceske Budejovice	Jihoceský
Czechia	Nemocnice Cesky Krumlov	Ceský Krumlov
Czechia	Endokrinologie MUDr. Rehorkova s.r.o.	Hradec Kralove
Czechia	MUDr. Sabina Palova	Jilove u Prahy	Praha-západ
Czechia	MUDr. Tomas Edelsberger	Krnov	Moravskosl
Czechia	Diahelp s.r.o	Pardubice V	Pardubice
Czechia	Dialine - Interni a diabetologicka ambulance	Pilsen	Plzen-mesto
Czechia	MUDr. Jitka Zemanová - diabetologie a interna s.r.o.	Plzen
Czechia	Diabet2 s.r.o., diabetologicka a interni ambulance	Praha	Praha 1
Czechia	Milan Kvapil s.r.o., Diabetologicka ambulance	Praha	Praha 4
Czechia	ResTrial s.r.o.	Praha	Praha 8
Czechia	Milan Kvapil s.r.o., Diabetologicka ambulance Pribram	Pribram	Stredoceský Kraj
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	Medizentrum Essen Borbeck	Essen	Nordrhein-Westfalen
Germany	Diabetes Zentrum Dr. Tews	Gelnhausen
Germany	Diabetes Zentrum Wilhelmsburg	Hamburg
Germany	Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weißenfels	Hohenmölsen	Sachsen-Anhalt
Germany	University Hospital of Cologne	Köln	Nordrhein-Westfalen
Germany	AmBeNet GmbH	Leipzig	Sachsen
Germany	Universität zu Lübeck - Institut für Endokrinologie und Diabetes	Lübeck	Schleswig-Holstein
Germany	SMO.MD GmbH	Magdeburg	Sachsen-Anhalt
Germany	CDG Studienambulanz Hartard	München	Bayern
Germany	Institut für Diabetesforschung GmbH Münster	Münster	Nordrhein-
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Private Practice - Dr. Christine Kosch	Pirna	Sachsen
Germany	Diabetologische Schwerpunktpraxis Marck Linn Pickel	Pohlheim	Hessen
Germany	Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf	Wallerfing	Bayern
Greece	Athens Medical Center	Athens	Attikí
Greece	University General Hospital of Larissa	Larissa	Thessalía
Greece	424 Military General Training Hospital	Thessaloniki
Greece	Euromedica General Clinic of Thessaloniki	Thessaloniki	Thessaloníki
Greece	Ippokrateio General Hospital of Thessaloniki	Thessaloniki	Kentrikí Makedonía
Greece	Papageorgiou General Hospital of Thessaloniki	Thessaloniki	Thessaloníki
Greece	Thermi Clinic	Thessaloniki	Thessaloníki
India	Medstar Speciality Hospital	Bangalore	Karnataka
India	Karnataka Institute of Medical Sciences	Hubli	Karnataka
India	Kumudini Devi Diabetes Research Center	Hyderabad	Telangana
India	TOTALL Diabetes Hormone Institute	Indore	Madhya Pradesh
India	Arthur Asirvatham Hospital	Madurai	Tamil Nadu
India	BSES MG Hospital	Mumbai	Maharashtra
India	Topiwala National Medical College & B. Y. L. Nair Charitable Hospital	Mumbai	Maharashtra
India	All India Institute of Medical Sciences (AIIMS) - Nagpur	Nagpur	Maharashtra
India	Sahyadri Super Speciality Hospital	Pune	Maharashtra
Korea, Republic of	Yeungnam Univeristy Medical Center	Gyeongsan-si	Kyongsangbuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Yonsei University-Wonju Severance Christian Hospital	Wonju	Kang-won-do
Puerto Rico	Advanced Clinical Research, LLC	Bayamón
Puerto Rico	Private Practice - Dr. Paola Mansilla-Letelier	Guaynabo
United States	Albany Medical College, Division of Community Endocrinology	Albany	New York
United States	Albany Stratton VA Medical Center	Albany	New York
United States	Albuquerque Neuroscience Inc.	Albuquerque	New Mexico
United States	MedStar Good Samaritan Hospital	Baltimore	Maryland
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Soma Clinical Trials	Denison	Texas
United States	Epic Medical Research - DeSoto	DeSoto	Texas
United States	AMCR Institute	Escondido	California
United States	Encore Medical Research	Hollywood	Florida
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Biopharma Informatic, LLC	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Balanced Life Health Care Solutions/SKYCRNG	Lawrenceville	Georgia
United States	NYC Research INC	Long Island City	New York
United States	National Research Institute - Wilshire	Los Angeles	California
United States	South Florida Clinical Research Institute	Margate	Florida
United States	Solaris Clinical Research	Meridian	Idaho
United States	Catalina Research Institute, LLC	Montclair	California
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Cahaba Research - Pelham	Pelham	Alabama
United States	Summit Headlands	Portland	Oregon
United States	Accellacare - Raleigh	Raleigh	North Carolina
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Diabetes and Glandular Disease Center	San Antonio	Texas
United States	VIP Trials	San Antonio	Texas
United States	Universal Research Group	Tacoma	Washington
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	Novak Clinical Research - Tucson - North La Cholla Boulevard	Tucson	Arizona
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	Yuma Clinical Trials	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  China,  Czechia,  Germany,  Greece,  India,  Korea, Republic of,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change from Baseline in Body Weight		Baseline, Week 72
Secondary	Mean Change from Baseline in Waist Circumference		Baseline, Week 72
Secondary	Mean Change from Baseline in Hemoglobin A1c (HbA1c) %		Baseline, Week 72
Secondary	Mean Change from Baseline in Fasting Glucose		Baseline, Week 72
Secondary	Mean Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 72
Secondary	Mean Change from Baseline in Fasting Triglycerides		Baseline, Week 72
Secondary	Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol		Baseline, Week 72
Secondary	Mean Percent Change from Baseline in Fasting Insulin		Baseline, Week 72
Secondary	Mean Change from Baseline in Diastolic Blood Pressure (DBP)		Baseline, Week 72
Secondary	Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores		Baseline, Week 72

External Links

•   A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)