A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
ATTAIN-1
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 Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)
4 other identifiers
interventional
3,127
10 countries
138
Brief Summary
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
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
Longer than P75 for phase_3 obesity
138 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 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedNovember 5, 2025
November 1, 2025
2.1 years
May 12, 2023
November 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Percent Change from Baseline in Body Weight
Baseline to Week 72
Secondary Outcomes (11)
Mean Change from Baseline in Waist Circumference
Baseline, Week 72
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 72
Mean Percent Change from Baseline in Fasting non-HDL Cholesterol
Baseline, Week 72
Mean Percent Change from Baseline in Fasting Triglycerides
Baseline, Week 72
Mean Change from Baseline in Hemoglobin A1c (HbA1c) %
Baseline, Week 72
- +6 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 be given placebo.
Interventions
Administered orally.
Eligibility Criteria
You may qualify if:
- Have a BMI
- ≥30.0 kilogram/square meter (kg/m²),
- ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:
- Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
You may not qualify if:
- Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
- Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
- Have had a history of chronic or acute pancreatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (138)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, 85375, United States
John Muir Physician Network Research Center
Concord, California, 94520, United States
AMCR Institute
Escondido, California, 92025, United States
NorCal Medical Research, Inc
Greenbrae, California, 94904, 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
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
New Age Medical Research Corporation
Miami, Florida, 33186, United States
South Broward Research
Miramar, Florida, 33027, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Jedidiah Clinical Research - Tampa - Bay Plaza
Tampa, Florida, 33619, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789, United States
Physicians Research Associates
Lawrenceville, Georgia, 30046, United States
East Coast Institute for Research, LLC
Macon, Georgia, 31210, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Care Access - Lake Charles
Lake Charles, Louisiana, 70601, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, 20782, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Long Island Cardiovascular Consultants
Lake Success, New York, 11042, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731, United States
Thyroid, Endocrinology, and Diabetes
Dallas, Texas, 75208, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Cedar Health Research
Dallas, Texas, 75251, United States
Juno Research
Houston, Texas, 77054, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Soma Clinical Trials
Wylie, Texas, 75098, United States
Physicians' Research Options
Draper, Utah, 84020, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas
Fortaleza, Ceará, 60430-350, Brazil
CEDOES
Vitória, Espírito Santo, 29055450, Brazil
Hospital São Domingos
Bequimão, Maranhão, 65060-645, Brazil
Cline Research Center
Curitiba, Paraná, 80030-480, Brazil
Quanta Diagnóstico e Terapia
Curitiba, Paraná, 80045170, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13060-803, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, 17201130, Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Integral Pesquisa e Ensino
Votuporanga, São Paulo, 15501-405, Brazil
Hospital São Lucas de Copacabana
Rio de Janeiro, 22061-080, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
Hospital das Clinicas FMUSP
São Paulo, 05403-000, 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, 404117, China
ShenZhen People's Hospital
Shenzhen, Guangdong, 518020, China
Hainan General Hospital
Haikou, Hainan, 570311, 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
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Jiading District Central Hospital
Shanghai, Shanghai Municipality, 201800, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, Tianjin Municipality, 300134, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
Endolife Speciality Hospitals
Guntur, Andhra Pradesh, 522001, India
Victoria Hospital, Bangalore Medical College And Research Institute
Bangalore, Karnataka, 560002, India
Mysore Medical College
Mysore, Karnataka, 570001, India
Central India Cardiology and Research Institute
Nagpur, Maharashtra, 440015, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, Maharashtra, 441108, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057, India
Oishi Clinic
Wakasugi, Fukuoka, 811-2310, Japan
Mazda Hospital
Aki-gun, Hiroshima, 735-0017, Japan
Tsuchiura Medical & Health Care Center
Tsuchiura, Ibaraki, 300-0012, Japan
NTT Nishinihon Takamatsu Clinic
Takamatsu, Kagawa-ken, 760-0076, Japan
Iwamoto Internal Medicine Clinic
Zentsujichó, Kagawa-ken, 765-0071, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, 232-0064, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853, Japan
Sugiura Internal Medicine Clinic
Sōka, Saitama, 340-0015, Japan
Adachi Kyosai Hospital
Adachi-ku, Tokyo, 120-0022, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Yutenji Medical Clinic
Meguro-ku, Tokyo, 153-0053, Japan
Kanno Naika
Mitaka, Tokyo, 181-0013, Japan
Shimokitazawa Tomo Clinic
Setagaya-ku, Tokyo, 155-0031, Japan
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008, Japan
Boocs Clinic Fukuoka
Fukuoka, 812-0025, Japan
Osaka Nishiumeda Clinic
Osaka, 530-0001, Japan
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917, Puerto Rico
Dorado Medical Complex
Dorado, 00646, Puerto Rico
Nemocnica s poliklinikou Lucenec
Lučenec, Banská Bystrica Region, 984 01, Slovakia
Metabol KLINIK
Bratislava, Bratislava Region, 811 08, Slovakia
Human Care s.r.o.
Košice, Košice Region, 04001, Slovakia
Areteus s.r.o.
Trebišov, Košice Region, 075 01, Slovakia
DIAB sro
Rožňava, Košický Kr, 048 01, Slovakia
MEDI-DIA s.r.o.
Sabinov, Presov, 083 01, Slovakia
DIA-MED CENTRUM s.r.o.
Púchov, Trenčín Region, 020 01, Slovakia
MediTask
Bratislava, 831 03, Slovakia
Gachon University Gil Medical Center
Namdong-gu, Incheon-gw, 21565, South Korea
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, 15355, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Kyǒnggi-do, 14068, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499, South Korea
Pusan National University Yangsan Hospital
Busan, Kyǒngsangnam-do, 50612, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Konyang University Hospital
Seogu, Taejǒn-Kwangyǒkshi, 35365, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006, Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, A Coruña [La Coruña], 15405, Spain
Centro Periférico de Especialidades Bola Azul
Almería, Almería, 04009, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Hospital Quiron Infanta Luisa
Seville, Andalusia, 41010, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [Barcelona], 08916, Spain
Centro Médico Teknon
Barcelona, Barcelona [Barcelona], 08022, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, 47010, Spain
Hospital Virgen del Camino
Sanlúcar de Barrameda, Cádiz, 11540, Spain
Hospital Virgen de las Montañas
Villamartín, Cádiz, 11650, Spain
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Chiayi Christian Hospital
Chiayi City, Chiayi, 600, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
Changhua Christian Hospital
Changhua, 50006, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Related Publications (1)
Wharton S, Aronne LJ, Stefanski A, Alfaris NF, Ciudin A, Yokote K, Halpern B, Shukla AP, Zhou C, Macpherson L, Allen SE, Ahmad NN, Klise SR; ATTAIN-1 Trial Investigators. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment. N Engl J Med. 2025 Nov 6;393(18):1796-1806. doi: 10.1056/NEJMoa2511774. Epub 2025 Sep 16.
PMID: 40960239DERIVED
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 8 AM - 8 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 12, 2023
First Posted
May 22, 2023
Study Start
June 5, 2023
Primary Completion
July 25, 2025
Study Completion (Estimated)
October 1, 2027
Last Updated
November 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.