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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

3127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-05

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Overweight Overweight or Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Orforglipron Dose 1

Participants will receive orforglipron administered orally.

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally.

Orforglipron Dose 2

Participants will receive orforglipron administered orally.

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally.

Orforglipron Dose 3

Participants will receive orforglipron administered orally.

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally.

Placebo

Participants will be given placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Orforglipron

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3502970

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

Chandler, Arizona, United States

Site Status

Clinical Research Institute of Arizona (CRI) - Sun City West

Sun City West, Arizona, United States

Site Status

John Muir Physician Network Research Center

Concord, California, United States

Site Status

AMCR Institute

Escondido, California, United States

Site Status

NorCal Medical Research, Inc

Greenbrae, California, United States

Site Status

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Site Status

Velocity Clinical Research, Westlake

Los Angeles, California, United States

Site Status

Catalina Research Institute, LLC

Montclair, California, United States

Site Status

Norcal Endocrinology & Internal Medicine

San Ramon, California, United States

Site Status

University Clinical Investigators, Inc.

Tustin, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

New Age Medical Research Corporation

Miami, Florida, United States

Site Status

South Broward Research

Miramar, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Physicians Research Associates

Lawrenceville, Georgia, United States

Site Status

East Coast Institute for Research, LLC

Macon, Georgia, United States

Site Status

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Elite Clinical Trials

Blackfoot, Idaho, United States

Site Status

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Site Status

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Site Status

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Care Access - Lake Charles

Lake Charles, Louisiana, United States

Site Status

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, United States

Site Status

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Site Status

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Site Status

Jinan Central Hospital

Jinan, Shandong, China

Site Status

Jiading District Central Hospital

Shanghai, Shanghai Municipality, China

Site Status

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University Zhu Xianyi Memorial Hospital

Tianjin, Tianjin Municipality, China

Site Status

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Site Status

Zhejiang Hospital

Hangzhou, Zhejiang, China

Site Status

Ningbo First Hospital

Ningbo, Zhejiang, China

Site Status

Endolife Speciality Hospitals

Guntur, Andhra Pradesh, India

Site Status

Victoria Hospital, Bangalore Medical College And Research Institute

Bangalore, Karnataka, India

Site Status

Mysore Medical College

Mysore, Karnataka, India

Site Status

Central India Cardiology and Research Institute

Nagpur, Maharashtra, India

Site Status

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, Maharashtra, India

Site Status

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, India

Site Status

Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

Site Status

Lifepoint Multispeciality Hospital

Pune, Maharashtra, India

Site Status

Oishi Clinic

Wakasugi, Fukuoka, Japan

Site Status

Mazda Hospital

Aki-gun, Hiroshima, Japan

Site Status

Tsuchiura Medical & Health Care Center

Tsuchiura, Ibaraki, Japan

Site Status

NTT Nishinihon Takamatsu Clinic

Takamatsu, Kagawa-ken, Japan

Site Status

Iwamoto Internal Medicine Clinic

Zentsujichó, Kagawa-ken, Japan

Site Status

Yokohama Minoru Clinic

Yokohama, Kanagawa, Japan

Site Status

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan

Site Status

Sugiura Internal Medicine Clinic

Sōka, Saitama, Japan

Site Status

Adachi Kyosai Hospital

Adachi-ku, Tokyo, Japan

Site Status

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Site Status

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, Japan

Site Status

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Site Status

Yutenji Medical Clinic

Meguro-ku, Tokyo, Japan

Site Status

Kanno Naika

Mitaka, Tokyo, Japan

Site Status

Shimokitazawa Tomo Clinic

Setagaya-ku, Tokyo, Japan

Site Status

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, Japan

Site Status

Boocs Clinic Fukuoka

Fukuoka, , Japan

Site Status

Osaka Nishiumeda Clinic

Osaka, , Japan

Site Status

Gachon University Gil Medical Center

Namdong-gu, Incheon-gw, South Korea

Site Status

Korea University Ansan Hospital

Ansan-si, Kyǒnggi-do, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang-si, Kyǒnggi-do, South Korea

Site Status

Jedidiah Clinical Research - Tampa - Bay Plaza

Tampa, Florida, United States

Site Status

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, United States

Site Status

Endocrine and Metabolic Consultants

Rockville, Maryland, United States

Site Status

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Site Status

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Long Island Cardiovascular Consultants

Lake Success, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Site Status

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Site Status

Thyroid, Endocrinology, and Diabetes

Dallas, Texas, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

Cedar Health Research

Dallas, Texas, United States

Site Status

Juno Research

Houston, Texas, United States

Site Status

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

Soma Clinical Trials

Wylie, Texas, United States

Site Status

Physicians' Research Options

Draper, Utah, United States

Site Status

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Site Status

Eastside Research Associates

Redmond, Washington, United States

Site Status

Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas

Fortaleza, Ceará, Brazil

Site Status

CEDOES

Vitória, Espírito Santo, Brazil

Site Status

Hospital São Domingos

Bequimão, Maranhão, Brazil

Site Status

Cline Research Center

Curitiba, Paraná, Brazil

Site Status

Quanta Diagnóstico e Terapia

Curitiba, Paraná, Brazil

Site Status

Núcleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, Brazil

Site Status

CECIP - Centro de Estudos do Interior Paulista

Jaú, São Paulo, Brazil

Site Status

Centro Multidisciplinar de Estudos Clinicos

São Bernardo do Campo, São Paulo, Brazil

Site Status

Integral Pesquisa e Ensino

Votuporanga, São Paulo, Brazil

Site Status

Hospital São Lucas de Copacabana

Rio de Janeiro, , Brazil

Site Status

CPQuali Pesquisa Clínica

São Paulo, , Brazil

Site Status

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, , Brazil

Site Status

Hospital das Clinicas FMUSP

São Paulo, , Brazil

Site Status

The Second People's Hospital of Hefei

Hefei, Anhui, China

Site Status

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

Site Status

ShenZhen People's Hospital

Shenzhen, Guangdong, China

Site Status

Hainan General Hospital

Haikou, Hainan, China

Site Status

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Henan, China

Site Status

GCM Medical Group, PSC - Hato Rey Site

San Juan, PR, Puerto Rico

Site Status

Dorado Medical Complex

Dorado, , Puerto Rico

Site Status

Nemocnica s poliklinikou Lucenec

Lučenec, Banská Bystrica Region, Slovakia

Site Status

Metabol KLINIK

Bratislava, Bratislava Region, Slovakia

Site Status

Human Care s.r.o.

Košice, Košice Region, Slovakia

Site Status

Areteus s.r.o.

Trebišov, Košice Region, Slovakia

Site Status

DIAB sro

Rožňava, Košický Kr, Slovakia

Site Status

MEDI-DIA s.r.o.

Sabinov, Presov, Slovakia

Site Status

DIA-MED CENTRUM s.r.o.

Púchov, Trenčín Region, Slovakia

Site Status

MediTask

Bratislava, , Slovakia

Site Status

Ajou University Hospital

Suwon, Kyǒnggi-do, South Korea

Site Status

Pusan National University Yangsan Hospital

Busan, Kyǒngsangnam-do, South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Konyang University Hospital

Seogu, Taejǒn-Kwangyǒkshi, South Korea

Site Status

Centro Periférico de Especialidades Bola Azul

Almería, Almería, Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Site Status

Hospital Quiron Infanta Luisa

Seville, Andalusia, Spain

Site Status

Hospital Germans Trias i Pujol

Badalona, Barcelona [Barcelona], Spain

Site Status

Centro Médico Teknon

Barcelona, Barcelona [Barcelona], Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Site Status

Hospital Clínico Universitario de Valladolid

Valladolid, Castille and León, Spain

Site Status

Hospital Virgen del Camino

Sanlúcar de Barrameda, Cádiz, Spain

Site Status

Hospital Virgen de las Montañas

Villamartín, Cádiz, Spain

Site Status

Hospital General Universitario de Valencia

Valencia, Valenciana, Comunitat, Spain

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

Chiayi Christian Hospital

Chiayi City, Chiayi, Taiwan

Site Status

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Site Status

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], Spain

Site Status

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, A Coruña [La Coruña], Spain

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Brazil China India Japan Puerto Rico Slovakia South Korea Spain Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40960239 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trials.lilly.com/en-US/trial/403875

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.