A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
NCT ID: NCT05869903
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
3127 participants
INTERVENTIONAL
2023-06-05
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Orforglipron Dose 1
Participants will receive orforglipron administered orally.
Orforglipron
Administered orally.
Orforglipron Dose 2
Participants will receive orforglipron administered orally.
Orforglipron
Administered orally.
Orforglipron Dose 3
Participants will receive orforglipron administered orally.
Orforglipron
Administered orally.
Placebo
Participants will be given placebo.
Placebo
Administered orally.
Interventions
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Orforglipron
Administered orally.
Placebo
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, United States
John Muir Physician Network Research Center
Concord, California, United States
AMCR Institute
Escondido, California, United States
NorCal Medical Research, Inc
Greenbrae, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
New Age Medical Research Corporation
Miami, Florida, United States
South Broward Research
Miramar, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Physicians Research Associates
Lawrenceville, Georgia, United States
East Coast Institute for Research, LLC
Macon, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Care Access - Lake Charles
Lake Charles, Louisiana, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, United States
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Jinan Central Hospital
Jinan, Shandong, China
Jiading District Central Hospital
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, Tianjin Municipality, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Endolife Speciality Hospitals
Guntur, Andhra Pradesh, India
Victoria Hospital, Bangalore Medical College And Research Institute
Bangalore, Karnataka, India
Mysore Medical College
Mysore, Karnataka, India
Central India Cardiology and Research Institute
Nagpur, Maharashtra, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Lifepoint Multispeciality Hospital
Pune, Maharashtra, India
Oishi Clinic
Wakasugi, Fukuoka, Japan
Mazda Hospital
Aki-gun, Hiroshima, Japan
Tsuchiura Medical & Health Care Center
Tsuchiura, Ibaraki, Japan
NTT Nishinihon Takamatsu Clinic
Takamatsu, Kagawa-ken, Japan
Iwamoto Internal Medicine Clinic
Zentsujichó, Kagawa-ken, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
Sugiura Internal Medicine Clinic
Sōka, Saitama, Japan
Adachi Kyosai Hospital
Adachi-ku, Tokyo, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Yutenji Medical Clinic
Meguro-ku, Tokyo, Japan
Kanno Naika
Mitaka, Tokyo, Japan
Shimokitazawa Tomo Clinic
Setagaya-ku, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Boocs Clinic Fukuoka
Fukuoka, , Japan
Osaka Nishiumeda Clinic
Osaka, , Japan
Gachon University Gil Medical Center
Namdong-gu, Incheon-gw, South Korea
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Kyǒnggi-do, South Korea
Jedidiah Clinical Research - Tampa - Bay Plaza
Tampa, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Long Island Cardiovascular Consultants
Lake Success, New York, United States
Weill Cornell Medical College
New York, New York, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Thyroid, Endocrinology, and Diabetes
Dallas, Texas, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Cedar Health Research
Dallas, Texas, United States
Juno Research
Houston, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Soma Clinical Trials
Wylie, Texas, United States
Physicians' Research Options
Draper, Utah, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Eastside Research Associates
Redmond, Washington, United States
Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas
Fortaleza, Ceará, Brazil
CEDOES
Vitória, Espírito Santo, Brazil
Hospital São Domingos
Bequimão, Maranhão, Brazil
Cline Research Center
Curitiba, Paraná, Brazil
Quanta Diagnóstico e Terapia
Curitiba, Paraná, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, São Paulo, Brazil
Integral Pesquisa e Ensino
Votuporanga, São Paulo, Brazil
Hospital São Lucas de Copacabana
Rio de Janeiro, , Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, , Brazil
Hospital das Clinicas FMUSP
São Paulo, , Brazil
The Second People's Hospital of Hefei
Hefei, Anhui, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
ShenZhen People's Hospital
Shenzhen, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, Puerto Rico
Dorado Medical Complex
Dorado, , Puerto Rico
Nemocnica s poliklinikou Lucenec
Lučenec, Banská Bystrica Region, Slovakia
Metabol KLINIK
Bratislava, Bratislava Region, Slovakia
Human Care s.r.o.
Košice, Košice Region, Slovakia
Areteus s.r.o.
Trebišov, Košice Region, Slovakia
DIAB sro
Rožňava, Košický Kr, Slovakia
MEDI-DIA s.r.o.
Sabinov, Presov, Slovakia
DIA-MED CENTRUM s.r.o.
Púchov, Trenčín Region, Slovakia
MediTask
Bratislava, , Slovakia
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea
Pusan National University Yangsan Hospital
Busan, Kyǒngsangnam-do, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Konyang University Hospital
Seogu, Taejǒn-Kwangyǒkshi, South Korea
Centro Periférico de Especialidades Bola Azul
Almería, Almería, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Quiron Infanta Luisa
Seville, Andalusia, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [Barcelona], Spain
Centro Médico Teknon
Barcelona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, Spain
Hospital Virgen del Camino
Sanlúcar de Barrameda, Cádiz, Spain
Hospital Virgen de las Montañas
Villamartín, Cádiz, Spain
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Chiayi Christian Hospital
Chiayi City, Chiayi, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, A Coruña [La Coruña], Spain
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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References
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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 Sep 16. doi: 10.1056/NEJMoa2511774. Online ahead of print.
Related Links
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A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)
Other Identifiers
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J2A-MC-GZGP
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502839-19-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1289-8877
Identifier Type: OTHER
Identifier Source: secondary_id
18559
Identifier Type: -
Identifier Source: org_study_id
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