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ObesityPhase 3ATTAIN-1NCT05869903

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

A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 138 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight, Overweight or Obesity
What is being tested?
Orforglipron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,127 participants
Where
138 sitesin 10 countries
Study dates
5 Jun 2023to Oct 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

138 sites in 10 countries.

138 sites in 10 countries

United States43 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

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

    Chandler, Arizona, 85225

  • John Muir Physician Network Research Center

    Concord, California, 94520

  • Thyroid, Endocrinology, and Diabetes

    Dallas, Texas, 75208

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Cedar Health Research

    Dallas, Texas, 75251

  • Physicians' Research Options

    Draper, Utah, 84020

  • AMCR Institute

    Escondido, California, 92025

  • NorCal Medical Research, Inc

    Greenbrae, California, 94904

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Juno Research

    Houston, Texas, 77054

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • MedStar Health Research Institute (MedStar Physician Based Research Network)

    Hyattsville, Maryland, 20782

  • Care Access - Lake Charles

    Lake Charles, Louisiana, 70601

  • Long Island Cardiovascular Consultants

    Lake Success, New York, 11042

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • Physicians Research Associates

    Lawrenceville, Georgia, 30046

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057

  • East Coast Institute for Research, LLC

    Macon, Georgia, 31210

  • New Age Medical Research Corporation

    Miami, Florida, 33186

  • South Broward Research

    Miramar, Florida, 33027

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Weill Cornell Medical College

    New York, New York, 10021

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Eastside Research Associates

    Redmond, Washington, 98052

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Norcal Endocrinology & Internal Medicine

    San Ramon, California, 94583

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

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

    Sun City West, Arizona, 85375

  • Jedidiah Clinical Research - Tampa - Bay Plaza

    Tampa, Florida, 33619

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida, 32789

  • Soma Clinical Trials

    Wylie, Texas, 75098

Other trials in United States

China20 sites

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 404117

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310013

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230011

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650034

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan, 471003

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • Jiading District Central Hospital

    Shanghai, Shanghai Municipality, 201800

  • ShenZhen People's Hospital

    Shenzhen, Guangdong, 518020

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Zhu Xianyi Memorial Hospital

    Tianjin, Tianjin Municipality, 300134

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000

Other trials in China

Japan18 sites

  • Adachi Kyosai Hospital

    Adachi-ku, Tokyo, 120-0022

  • Mazda Hospital

    Aki-gun, Hiroshima, 735-0017

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0027

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Boocs Clinic Fukuoka

    Fukuoka, 812-0025

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo, 153-0053

  • Kanno Naika

    Mitaka, Tokyo, 181-0013

  • Osaka Nishiumeda Clinic

    Osaka, 530-0001

  • Shimokitazawa Tomo Clinic

    Setagaya-ku, Tokyo, 155-0031

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008

  • Sugiura Internal Medicine Clinic

    Sōka, Saitama, 340-0015

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853

  • NTT Nishinihon Takamatsu Clinic

    Takamatsu, Kagawa-ken, 760-0076

  • Tsuchiura Medical & Health Care Center

    Tsuchiura, Ibaraki, 300-0012

  • Oishi Clinic

    Wakasugi, Fukuoka, 811-2310

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa, 232-0064

  • Iwamoto Internal Medicine Clinic

    Zentsujichó, Kagawa-ken, 765-0071

Other trials in Japan

Brazil14 sites

  • Hospital São Domingos

    Bequimão, Maranhão, 65060-645

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo, 13060-803

  • Cline Research Center

    Curitiba, Paraná, 80030-480

  • Quanta Diagnóstico e Terapia

    Curitiba, Paraná, 80045170

  • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas

    Fortaleza, Ceará, 60430-350

  • CECIP - Centro de Estudos do Interior Paulista

    Jaú, São Paulo, 17201130

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Hospital São Lucas de Copacabana

    Rio de Janeiro, 22061-080

  • Centro Multidisciplinar de Estudos Clinicos

    São Bernardo do Campo, São Paulo, 09715-090

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

  • Hospital das Clinicas FMUSP

    São Paulo, 05403-000

  • CEDOES

    Vitória, Espírito Santo, 29055450

  • Integral Pesquisa e Ensino

    Votuporanga, São Paulo, 15501-405

Other trials in Brazil

Spain13 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña], 15006

  • Centro Periférico de Especialidades Bola Azul

    Almería, Almería, 04009

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [Barcelona], 08916

  • Centro Médico Teknon

    Barcelona, Barcelona [Barcelona], 08022

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

    Ferrol, A Coruña [La Coruña], 15405

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Virgen del Camino

    Sanlúcar de Barrameda, Cádiz, 11540

  • Hospital Quiron Infanta Luisa

    Seville, Andalusia, 41010

  • Hospital General Universitario de Valencia

    Valencia, Valenciana, Comunitat, 46014

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Castille and León, 47010

  • Hospital Virgen de las Montañas

    Villamartín, Cádiz, 11650

Other trials in Spain

India8 sites

  • Victoria Hospital, Bangalore Medical College And Research Institute

    Bangalore, Karnataka, 560002

  • Endolife Speciality Hospitals

    Guntur, Andhra Pradesh, 522001

  • Mysore Medical College

    Mysore, Karnataka, 570001

  • Central India Cardiology and Research Institute

    Nagpur, Maharashtra, 440015

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, Maharashtra, 441108

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004

  • Lifepoint Multispeciality Hospital

    Pune, Maharashtra, 411057

Other trials in India

Slovakia8 sites

  • Metabol KLINIK

    Bratislava, Bratislava Region, 811 08

  • MediTask

    Bratislava, 831 03

  • Human Care s.r.o.

    Košice, Košice Region, 04001

  • Nemocnica s poliklinikou Lucenec

    Lučenec, Banská Bystrica Region, 984 01

  • DIA-MED CENTRUM s.r.o.

    Púchov, Trenčín Region, 020 01

  • DIAB sro

    Rožňava, Košický Kr, 048 01

  • MEDI-DIA s.r.o.

    Sabinov, Presov, 083 01

  • Areteus s.r.o.

    Trebišov, Košice Region, 075 01

Other trials in Slovakia

South Korea7 sites

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do, 15355

  • Hallym University Sacred Heart Hospital

    Anyang-si, Kyǒnggi-do, 14068

  • Pusan National University Yangsan Hospital

    Busan, Kyǒngsangnam-do, 50612

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gw, 21565

  • Konyang University Hospital

    Seogu, Taejǒn-Kwangyǒkshi, 35365

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499

Other trials in South Korea

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Chiayi Christian Hospital

    Chiayi City, Chiayi, 600

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • National Cheng Kung University Hospital

    Tainan, 704

Other trials in Taiwan

Puerto Rico2 sites

  • Dorado Medical Complex

    Dorado, 00646

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 00917

Other trials in Puerto Rico

About this study

Official title: 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)

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.

Being tested
Orforglipron, Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT05869903
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
Receives: Drug: Placebo
6 mg OrforglipronExperimentalPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
Receives: Drug: Orforglipron
12 mg OrforglipronExperimentalPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
Receives: Drug: Orforglipron
36 mg OrforglipronExperimentalPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
Receives: Drug: Orforglipron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight (Primary Treatment Period)

    Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

Secondary outcomes (11)

  1. Change From Baseline in Waist Circumference (Primary Treatment Period)

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  2. Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  3. Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  4. Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  5. Change From Baseline in HbA1c (Primary Treatment Period)

    • Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.
    • Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  6. Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period)

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  7. Percent Change From Baseline in Fasting Insulin (Primary Treatment Period)

    • Fasting insulin is a blood test that measures the level of insulin in the blood after fasting.
    • Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  8. Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 72

  9. Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical Component and Mental Component) Scores - (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.

    Measured: Baseline, Week 72

  10. Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)

    Measured: Baseline, Week 176

  11. Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)

    Measured: Baseline through Week 176, Baseline through Week 190

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start5 Jun 2023
  3. Primary completion25 Jul 2025
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05869903
Sponsor's protocol ID
18559
Other IDs
J2A-MC-GZGP, 2022-502839-19-00, U1111-1289-8877
Acronym
ATTAIN-1
Status last verified
Jul 2026
First submitted
12 May 2023
Last updated
14 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Almandoz JP, Miras AD, Bluher M, Orozco Del Pino P, Mojdami D, Batterham RL, Trice K, Goebel B, Tangi F. 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 Oct 14;20:100346. doi: 10.1016/j.obpill.2026.100346. eCollection 2026 Dec.

    PubMed 42936354

  • Shinde S, Kahles F, Vasileva-Metodiev S, Griffin R, Liu-Seifert H, Lebrec J, Xavier NA, Li R, Klise SR, Singh A, Aberle J. 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 Sep 17. doi: 10.1111/dom.71322. Online ahead of print.

    PubMed 42750540

  • Horn DB, Shukla AP, Huang H, Twum E, Allen SE, Kis SG. 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 Jul 14;19:100301. doi: 10.1016/j.obpill.2026.100301. eCollection 2026 Sep.

    PubMed 42577069

  • 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.

    PubMed 40960239

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 138 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, China, Japan, Brazil, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight (Primary Treatment Period) (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05869903, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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