A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
ATTAIN-2
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)
4 other identifiers
interventional
1,613
11 countries
136
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Jun 2023
Typical duration for phase_3 obesity
136 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedStudy Start
First participant enrolled
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2025
CompletedSeptember 18, 2025
September 1, 2025
2.2 years
May 15, 2023
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Percent Change from Baseline in Body Weight
Baseline, Week 72
Secondary Outcomes (9)
Mean Change from Baseline in Waist Circumference
Baseline, Week 72
Mean Change from Baseline in Hemoglobin A1c (HbA1c) %
Baseline, Week 72
Mean Change from Baseline in Fasting Glucose
Baseline, Week 72
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 72
Mean Change from Baseline in Fasting Triglycerides
Baseline, Week 72
- +4 more secondary outcomes
Study Arms (4)
Orforglipron Dose 1
EXPERIMENTALParticipants will receive orforglipron administered orally.
Orforglipron Dose 2
EXPERIMENTALParticipants will receive orforglipron administered orally.
Orforglipron Dose 3
EXPERIMENTALParticipants will receive orforglipron administered orally.
Placebo
PLACEBO COMPARATORParticipants will receive placebo
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (136)
Cahaba Research - Pelham
Pelham, Alabama, 35124, United States
Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson, Arizona, 85741, United States
Yuma Clinical Trials
Yuma, Arizona, 85364, United States
AMCR Institute
Escondido, California, 92025, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Encore Medical Research
Hollywood, Florida, 33024, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
South Florida Clinical Research Institute
Margate, Florida, 33063, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
IMA Clinical Research
Albuquerque, New Mexico, 87109, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203, United States
Albany Stratton VA Medical Center
Albany, New York, 12208, United States
NYC Research INC
Long Island City, New York, 11106, United States
Accellacare - Raleigh
Raleigh, North Carolina, 27609, United States
Summit Headlands
Portland, Oregon, 97210, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Soma Clinical Trials
Denison, Texas, 75020, United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Diabetes and Glandular Disease Center
San Antonio, Texas, 78229, United States
VIP Trials
San Antonio, Texas, 78230, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Universal Research Group
Tacoma, Washington, 98405, United States
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., C1128AAF, Argentina
CEMEDIAB
C.a.b.a., Ciudad Aut, C1205AAO, Argentina
Instituto Centenario
CABA, Ciudad Autónoma de Buenos Aire, 1204, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe Province, 2000, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio San Martin
Venado Tuerto, Santa Fe Province, 2600, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012, Argentina
Centro Diabetológico Dr. Waitman
Córdoba, 5000, Argentina
Clínica Universitaria Reina Fabiola
Córdoba, X50004FHP, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, 3000, Argentina
Emeritus Research
Botany, New South Wales, 2019, Australia
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, 2291, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Core Research Group
Brisbane, Queensland, 4064, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Austin Health - Repatriation Hospital
Heidelberg West, Victoria, 3081, Australia
Baker IDI Heart and Diabetes Institute - Melbourne
Melbourne, Victoria, 3004, Australia
Advara HeartCare Joondalup
Joondalup, Western Australia, 6027, Australia
Centro de Pesquisa Clinica do Brasil
Brasília, Federal District, 71625-175, Brazil
Cendi - Endocrinologia e Diabetes
Goiânia, Goiás, 74230-035, Brazil
Instituto Lóbus
Volta Redonda, Rio de Janeiro, 27253-003, Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande do Sul, 99010-120, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, 13060-080, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, São Paulo, 17504-072, Brazil
Pesquisare Saude
Santo André, São Paulo, 09080-110, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
The Second People's Hospital of Hefei
Hefei, Anhui, 230011, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014, China
ShenZhen People's Hospital
Shenzhen, Guangdong, 518020, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Jiangsu Province Official Hospital
Nanjing, Jiangsu, 210008, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nantong First People's Hospital
Nantong, Jiangsu, 226001, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, Tianjin Municipality, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034, China
Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
Příbram, Central Bohemia, 26201, Czechia
MUDr. Alena Vachova
České Budějovice, Jihočeský kraj, 37011, Czechia
MUDr. Tomas Edelsberger
Krnov, Moravskosl, 79401, Czechia
Diahelp s.r.o
Pardubice V, Pardubice, 530 02, Czechia
Dialine - Interni a diabetologicka ambulance
Pilsen, Plzeň-město, 301 00, Czechia
Diabet2 s.r.o., diabetologicka a interni ambulance
Prague, Praha 1, 11000, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, Praha 4, 14900, Czechia
ResTrial s.r.o.
Prague, Praha 8, 18100, Czechia
MUDr. Sabina Palova
Jílové u Prahy, Praha-západ, 252 42, Czechia
Nemocnice Cesky Krumlov
Český Krumlov, 381 01, Czechia
Endokrinologie MUDr. Rehorkova s.r.o.
Hradec Králové, 500 12, Czechia
MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
Pilsen, 326 00, Czechia
CDG Studienambulanz Hartard
München, Bavaria, 80809, Germany
Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
Wallerfing, Bavaria, 94574, Germany
Ceda-Research
Pohlheim, Hesse, 35415, Germany
Institut für Diabetesforschung GmbH Münster
Münster, Nordrhein-, 48145, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136, Germany
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, 45355, Germany
AmBeNet GmbH
Leipzig, Saxony, 04107, Germany
Arztpraxis Christine Kosch Pirna
Pirna, Saxony, 01796, Germany
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
Hohenmölsen, Saxony-Anhalt, 06679, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, 39120, Germany
Universität zu Lübeck - Institut für Endokrinologie und Diabetes
Lübeck, Schleswig-Holstein, 23562, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Diabetes Zentrum Dr. Tews
Gelnhausen, 63571, Germany
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109, Germany
Athens Medical Center
Athens, Attikí, 151 25, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, 54642, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, Thessaloníki, 546 45, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 564 29, Greece
Thermi Clinic
Thessaloniki, Thessaloníki, 570 01, Greece
University General Hospital of Larissa
Larissa, Thessalía, 41110, Greece
424 Military General Training Hospital
Thessaloniki, 564 29, Greece
Medstar Speciality Hospital
Bangalore, Karnataka, 560092, India
Karnataka Institute of Medical Sciences
Hubli, Karnataka, 580021, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, 400008, India
BSES MG Hospital
Mumbai, Maharashtra, 400058, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, Maharashtra, 441108, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Arthur Asirvatham Hospital
Madurai, Tamil Nadu, 625020, India
Kumudini Devi Diabetes Research Center
Hyderabad, Telangana, 500082, India
Advanced Clinical Research, LLC
Bayamón, PR, 00959, Puerto Rico
Isis Clinical Research Center
Guaynabo, PR, 00968, Puerto Rico
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Kang-won-do, 26426, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, Kyǒngsangbuk-do, 42415, South Korea
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 02841, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [Seoul], 134-090, South Korea
Related Publications (1)
Horn DB, Ryan DH, Kis SG, Alves B, Mu Y, Kim SG, Aberle J, Bain SC, Allen S, Sarker E, Wu Q, Stefanski A, Jouravskaya I; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2026 Dec 20;406(10522):2927-2944. doi: 10.1016/S0140-6736(25)02165-8. Epub 2025 Nov 20.
PMID: 41275875DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2023
First Posted
May 24, 2023
Study Start
June 5, 2023
Primary Completion
August 8, 2025
Study Completion
August 8, 2025
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.