NCT05869903Active, not recruitingPhase 3
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
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)
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 3127 (actual)
- First submitted
- 12 May 2023
- Start date
- 5 Jun 2023
- Primary completion date
- 25 Jul 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT05869903
- EU CT number
- 2022-502839-19-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 3127
- From 5 Jun 2023 to the primary completion date, 25 Jul 2025
- 137 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
Other illness
- Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (137)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital São Domingos Coordinator of this site? Confirm its status | Bequimão | Brazil | Unknown status |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Quanta Diagnóstico e Terapia Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Cline Research Center Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| CECIP - Centro de Estudos do Interior Paulista Coordinator of this site? Confirm its status | Jaú | Brazil | Unknown status |
| Nucleo de Pesquisa Clínica do Rio Grande do Sul Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital São Lucas de Copacabana Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Centro Multidisciplinar de Estudos Clinicos Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital das Clinicas FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Integral Pesquisa e Ensino Coordinator of this site? Confirm its status | Votuporanga | Brazil | Unknown status |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chongqing General Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Zhejiang Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Fourth Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The Second People's Hospital of Hefei Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First People's Hospital of Yunnan Province Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science &Technology Coordinator of this site? Confirm its status | Luoyang Shi | China | Unknown status |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Jiading District Central Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Zhu Xianyi Memorial Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Active, not recruiting |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Centro Médico Teknon Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Area Sanitaria De Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Virgen del Camino Coordinator of this site? Confirm its status | Sanlúcar de Barrameda | Spain | Active, not recruiting |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Active, not recruiting |
| Hospital Virgen de las Montañas Coordinator of this site? Confirm its status | Villamartín | Spain | Active, not recruiting |
| Victoria Hospital, Bangalore Medical College And Research Institute Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Endolife Speciality Hospitals Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| Mysore Medical College Coordinator of this site? Confirm its status | Mysore | India | Unknown status |
| Central India Cardiology and Research Institute Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| All India Institute of Medical Sciences (AIIMS) - Nagpur Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Sahyadri Super Speciality Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Deenanath Mangeshkar Hospital & Research Centre Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Lifepoint Multispeciality Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Adachi Kyosai Hospital Coordinator of this site? Confirm its status | Adachi-ku | Japan | Unknown status |
| Mazda Hospital Coordinator of this site? Confirm its status | Aki-gun | Japan | Unknown status |
| Medical Corporation Chiseikai Tokyo Center Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Boocs Clinic Fukuoka Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Yutenji Medical Clinic Coordinator of this site? Confirm its status | Meguro-ku | Japan | Unknown status |
| Kanno Naika Coordinator of this site? Confirm its status | Mitaka | Japan | Unknown status |
| Osaka Nishiumeda Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Shimokitazawa Tomo Clinic Coordinator of this site? Confirm its status | Setagaya-ku | Japan | Unknown status |
| Heishinkai Medical Group ToCROM Clinic Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Sugiura Internal Medicine Clinic Coordinator of this site? Confirm its status | Sōka | Japan | Unknown status |
| Medical Corporation Heishinkai OCROM Clinic Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| NTT Nishinihon Takamatsu Clinic Coordinator of this site? Confirm its status | Takamatsu | Japan | Unknown status |
| Tsuchiura Medical & Health Care Center Coordinator of this site? Confirm its status | Tsuchiura | Japan | Unknown status |
| Oishi Clinic Coordinator of this site? Confirm its status | Wakasugi | Japan | Unknown status |
| Yokohama Minoru Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Iwamoto Internal Medicine Clinic Coordinator of this site? Confirm its status | Zentsujichó | Japan | Unknown status |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si | South Korea | Unknown status |
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang-si | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Namdong-gu | South Korea | Unknown status |
| Konyang University Hospital Coordinator of this site? Confirm its status | Seogu | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Dorado Medical Complex Coordinator of this site? Confirm its status | Dorado | Puerto Rico | Unknown status |
| GCM Medical Group, PSC - Hato Rey Site Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| MediTask, s.r.o Coordinator of this site? Confirm its status | Bratislava | Slovakia | Active, not recruiting |
| Vseobecna Nemocnica S Poliklinikou n.o. Coordinator of this site? Confirm its status | Lucenec | Slovakia | Active, not recruiting |
| DIA-MED CENTRUM s.r.o. Coordinator of this site? Confirm its status | Púchov | Slovakia | Active, not recruiting |
| DIAB s.r.o. Coordinator of this site? Confirm its status | Rožňava | Slovakia | Active, not recruiting |
| MEDI-DIA s.r.o. Coordinator of this site? Confirm its status | Sabinov | Slovakia | Active, not recruiting |
| Metabol KLINIK s.r.o. Coordinator of this site? Confirm its status | Stare Mesto | Slovakia | Active, not recruiting |
| Areteus s.r.o. Coordinator of this site? Confirm its status | Trebišov | Slovakia | Active, not recruiting |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Chiayi Christian Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Memorial Hospital at Kaohsiung Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Elite Clinical Trials Coordinator of this site? Confirm its status | Blackfoot | United States | Unknown status |
| The Institute for Liver Health II dba Arizona Clinical Trials - Mesa Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| John Muir Physician Network Research Center Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Cedar Health Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Thyroid, Endocrinology, and Diabetes Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Physicians' Research Options Coordinator of this site? Confirm its status | Draper | United States | Unknown status |
| AMCR Institute Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| NorCal Medical Research, Inc Coordinator of this site? Confirm its status | Greenbrae | United States | Unknown status |
| East-West Medical Research Institute Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Velocity Clinical Research-Huntington Park Coordinator of this site? Confirm its status | Huntington Park | United States | Unknown status |
| MedStar Health Research Institute (MedStar Physician Based Research Network) Coordinator of this site? Confirm its status | Hyattsville | United States | Unknown status |
| Care Access - Lake Charles Coordinator of this site? Confirm its status | Lake Charles | United States | Unknown status |
| Long Island Cardiovascular Consultants Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Las Vegas Medical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Physicians Research Associates Coordinator of this site? Confirm its status | Lawrenceville | United States | Unknown status |
| Velocity Clinical Research, Westlake Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| East Coast Institute for Research, LLC Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| New Age Medical Research Corporation Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| South Broward Research Coordinator of this site? Confirm its status | Miramar | United States | Unknown status |
| Catalina Research Institute, LLC Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| Health Research of Hampton Roads, Inc. Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Eastside Research Associates Coordinator of this site? Confirm its status | Redmond | United States | Unknown status |
| SKY Integrative Medical Center/SKYCRNG Coordinator of this site? Confirm its status | Ridgeland | United States | Unknown status |
| Endocrine and Metabolic Consultants Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Norcal Endocrinology & Internal Medicine Coordinator of this site? Confirm its status | San Ramon | United States | Unknown status |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Clinical Research Institute of Arizona (CRI) - Sun City West Coordinator of this site? Confirm its status | Sun City West | United States | Unknown status |
| Jedidiah Clinical Research - Tampa - Bay Plaza Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Cotton O'Neil Clinical Research Center Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Cotton O'Neil Diabetes & Endocrinology Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| University Clinical Investigators, Inc. Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Unknown status |
| Clinical Site Partners, LLC dba Flourish Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
| Soma Clinical Trials Coordinator of this site? Confirm its status | Wylie | United States | Unknown status |
Related publications
- Efficacy and safety of orforglipron in adults with body mass index of 27 to less than 30 kg/m2 and adiposity-related complications: A post hoc analysis of the ATTAIN-1 trial.Obes Pillars · 2026 · PMID 42936354
- Predicting the Long-Term Risk of Type 2 Diabetes and Cardiovascular Disease With Orforglipron in People With Overweight or Obesity: A Post Hoc Analysis of the ATTAIN-1 Trial.Diabetes Obes Metab · 2026 · PMID 42750540
- Orforglipron for obesity treatment in older patients ≥65 years with or without type 2 diabetes: A post hoc subgroup analysis of the ATTAIN-1 and ATTAIN-2 trials.Obes Pillars · 2026 · PMID 42577069
This page is information, not medical advice. Discuss any trial with your doctor.