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OsteoarthritisPhase 3ATTAIN-OA PAINNCT07153471

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

A Phase 3 study testing Orforglipron in people with Osteoarthritis, run by Eli Lilly and Company at 88 sites in 7 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
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
800 participants
Where
88 sitesin 7 countries
Study dates
15 Sep 2025to May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening
  • Have tried at least once to lose weight through diet but were unsuccessful
  • Have osteoarthritis of the knee and at least one of the following conditions:
  • Be over 50 years old
  • Have morning knee stiffness that lasts about 30 minutes
  • Have a crackling or grinding sound or feeling in the knee

Who cannot join

  • Have gained or lost more than 11 pounds within 90 days prior to screening
  • Have had a surgery for obesity or plan to have one in the next 18 months
  • Have an active knee infection
  • Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
  • Have had a recent heart condition or New York Heart Association Functional Classification Class IV congestive heart failure
  • Have used any glucagon-like peptide-1 (GLP-1) receptor agonist medication within 180 days of screening

Trial locations and contacts

88 sites in 7 countries.

88 sites in 7 countries

United States26 sites

  • University Orthopedics Center

    Altoona, Pennsylvania, 16602

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Northwestern University

    Chicago, Illinois, 60611

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Legacy Clinical Trials

    Colorado Springs, Colorado, 80909

  • Mercy Family Clinic

    Dallas, Texas, 75208

  • Care Access - Decatur

    Decatur, Georgia, 30030

  • Juno Research

    Houston, Texas, 77040

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Care Access - Huntington Beach

    Huntington Beach, California, 92648

  • AMR Clinical

    Kansas City, Missouri, 64114

  • Activian Clinical Research

    Kingwood, Texas, 77339

  • AMR Clinical

    Knoxville, Tennessee, 37909

  • AMR Clinical

    Newton, Kansas, 67114

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Care Access - Rapid City

    Rapid City, South Dakota, 57701

  • Carolina Research Center

    Shelby, North Carolina, 28150

  • Cardio Metabolic Institute

    Somerset, New Jersey, 08873

  • AMR Clinical

    Tempe, Arizona, 85281

  • Advanced Rheumatology of Houston - Woodlands

    The Woodlands, Texas, 77382

  • Care Access - Thousand Oaks

    Thousand Oaks, California, 91360

  • Gershon Pain Specialists

    Virginia Beach, Virginia, 23454

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

China16 sites

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T

    Baotou, 014010

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

  • The Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400010

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, 150001

  • The Second People's Hospital of Hefei

    Hefei, 230011

  • Jinan Central Hospital

    Jinan, 250013

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

    Luoyang, 471003

  • Nanjing First Hospital

    Nanjing, 210006

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Nanjing Medical University - Nanjing Jiangning Hospital

    Nanjing, 211100

  • Pingxiang People's Hospital

    Pingxiang, 337055

  • The First Hospital of Qinhuangdao

    Qinhuangdao Shi, 066000

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, 515041

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, 518053

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317000

Other trials in China

Germany13 sites

  • Siteworks GmbH - Bochum

    Bochum, 44787

  • Klinische Forschung Dresden

    Dresden, 01069

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T

    Hamburg, 20095

  • Pratia - Hamburg

    Hamburg, 20253

  • Pratia - Hannover

    Hanover, 30159

  • Siteworks GmbH - Hannover

    Hanover, 30449

  • Klinische Forschung Karlsruhe

    Karlsruhe, 76137

  • Siteworks - Karlsruhe

    Karlsruhe, 76137

  • AmBeNet GmbH

    Leipzig, 04107

  • CDG Studienambulanz Hartard

    München, 80809

  • Dedicated Research Site FutureMeds

    Offenbach, 63065

  • Private Practice - Dr. Jochen Walter

    Rendsburg, 24768

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97074

Other trials in Germany

Japan11 sites

  • Hamanomachi Hospital

    Fukuoka, 810-8539

  • Fukuoka Wajiro Hospital

    Fukuoka, 811-0213

  • Shimane University Hospital

    Izumo, 693-8501

  • Kariya Toyota General Hospital

    Kariya, 448-8505

  • Ando Orthopedic

    Kawasaki, 213-0001

  • Tokyo Saiseikai Central Hospital

    Minatoku, 108-0073

  • Goto Orthopedic Surgery Clinic

    Miyazaki, 880-0835

  • Kato Orthopedic Clinic

    Morioka, 020-0021

  • Japan Community Health Care Organization - Saitama Medical Center

    Saitama, 330-0074

  • Sapporo Maruyama Orthopedic Hospital

    Sapporo, 060-0007

  • Masumoto Orthopedics Clinic

    Suginami City, 167-0051

Other trials in Japan

Canada8 sites

  • Aggarwal and Associates Limited

    Brampton, L6T 0G1

  • Diex Recherche Inc. Division Joliette

    Joliette, J6E 6A9

  • Your Research Network

    Niagara Falls, L2H 1H5

  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

    Québec, G1V 4K5

  • Alpha Recherche Clinique

    Québec, G2J 0C4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3

  • Winterberry Research Inc.

    Stoney Creek, L8J 0B6

Other trials in Canada

Spain8 sites

  • Hospital San Rafael - La Coruña

    A Coruña, 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Quirón Málaga

    Málaga, 29004

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Clínica Gaias - Santiago

    Santiago de Compostela, 15702

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003

  • Hospital Quiron Infanta Luisa

    Seville, 41010

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47010

Other trials in Spain

Mexico6 sites

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.

    Ciudad Madero, 89440

  • Kohler & Milstein Research S.A. De C.V.

    Mérida, 97070

  • Centro Medico del Angel

    Mexicali, 21100

  • IMED Internal Medicine Clin Trials

    Monterrey, 64020

  • Clínica García Flores SC

    Monterrey, 64610

Other trials in Mexico

About this study

Official title: A Phase 3 Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Trial

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.

Conditions
Osteoarthritis
Being tested
Orforglipron, Placebo
Keywords
Arthritis, Overnutrition, Nutrition Disorder, Joint Diseases, Musculoskeletal Disease, Knee Degeneration, Osteoarthrosis, Obese
Medical subject headings
Osteoarthritis, Arthritis, Overnutrition, Nutrition Disorders, Joint Diseases, Musculoskeletal Diseases, Obesity

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 NCT07153471
Study groupRoleWhat they receive
Orforglipron (GZT1)ExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
Placebo (GZT1)Placebo comparatorParticipants will receive placebo orally
Receives: Drug: Placebo
Orforglipron (GZT2)ExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
Placebo (GZT2)Placebo comparatorParticipants will receive placebo orally
Receives: Drug: Placebo

What is being measured

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

  1. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

    Measured: Baseline, Week 72

Secondary outcomes (17)

  1. Change from Baseline in the WOMAC Physical Function Subscale Score

    Measured: Baseline, Week 72

  2. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 72

  3. Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    Measured: Baseline, Week 72

  4. Change from Baseline in Distance Walked During the 6-Minute Walk Test

    Measured: Baseline, Week 72

  5. Percent Change from Baseline in High-Sensitivity, C-reactive Protein (hsCRP)

    Measured: Baseline, Week 72

  6. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 72

  7. Percent Change from Baseline in Tumor Necrosis Factor (TNF)-Alpha

    Measured: Baseline, Week 72

  8. Change from Baseline in WOMAC Stiffness Subscale

    Measured: Baseline, Week 72

  9. Change from Baseline in WOMAC Total Score

    Measured: Baseline, Week 72

  10. Change from Baseline in SF-36v2 Acute Form Domain Scores

    With exception of the Physical Functioning Domain Score

    Measured: Baseline, Week 72

  11. Percentage of Participants Who Achieve Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function

    Measured: Baseline, Week 72

  12. Percentage of Participants Who Achieve Improved Categorical Shift in PGIS - Target Knee Pain

    Measured: Baseline, Week 72

  13. Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score

    Measured: Baseline, Week 72

  14. Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score

    Measured: Baseline, Week 72

  15. Number of Participants with Allowed Concomitant Pain Medication

    Measured: Baseline, Week 72

  16. Percent Change from Baseline in Total Cholesterol

    Measured: Baseline, Week 72

  17. Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron

    Measured: Predose through Week 48

Timeline

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

  1. First posted4 Sep 2025
  2. Study start15 Sep 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionMay 2028 (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
Single blind
Who is masked
Participant
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153471
Sponsor's protocol ID
27633
Other IDs
2025-522631-34-00, J2A-MC-GZPT, J2A-MC-GZT1, J2A-MC-GZT2, 2025
Acronym
ATTAIN-OA PAIN
Status last verified
Oct 2026
First submitted
2 Sep 2025
Last updated
8 Oct 2026
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with Osteoarthritis, run by Eli Lilly and Company at 88 sites in 7 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 6 inclusion and 6 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, China, Germany, Japan, Canada and 2 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?

This study is still under way. Results are not available in the source record yet.

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?

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score (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 NCT07153471.

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 8 Oct 2026.

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