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NCT07153471ClinicalTrials.gov

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

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

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En resumen

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…

Fase 3800 participantes buscados88 centros7 países

Categorías

Musculoesquelético51%Endocrino y metabólico42%Inmunología y reumatología7%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-09-04; recorded start 2025-09-15
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 347 other studies in this databaseCounted from the lead sponsor named in the record (Eli Lilly and Company)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding7/20

    Single-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 95 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 800 participants (target), run at 88 sites, across 7 countries.

How this score is built
  • Enrolment29/40

    800 participants (target)

  • Site count22/25

    95 sites

  • Country count12/15

    8 countries

  • Planned duration8/10

    Planned over about 32 months

  • Sponsor scale9/10

    Eli Lilly and Company has led 326 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

  • Osteoarthritis

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoSINGLE (1)
Inscripción800 participantes buscados

Patrocinador y colaboradores

  • Eli Lilly and Company Patrocinador

Grupos e intervenciones

  • Orforglipron (GZT1)EXPERIMENTAL

    Participants will receive orforglipron orally

  • Placebo (GZT1)PLACEBO_COMPARATOR

    Participants will receive placebo orally

  • Orforglipron (GZT2)EXPERIMENTAL

    Participants will receive orforglipron orally

  • Placebo (GZT2)PLACEBO_COMPARATOR

    Participants will receive placebo orally

Intervenciones

  • Fármaco Orforglipron

    Administered orally

  • Fármaco Placebo

    Administered orally

Variables de resultado

  1. Variable de resultado principal

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

    Plazo Baseline, Week 72

  2. Variable de resultado secundaria

    Change from Baseline in the WOMAC Physical Function Subscale Score

    Plazo Baseline, Week 72

  3. Variable de resultado secundaria

    Percent Change from Baseline in Body Weight

    Plazo Baseline, Week 72

  4. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  5. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  6. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  7. Variable de resultado secundaria

    Change from Baseline in Waist Circumference

    Plazo Baseline, Week 72

  8. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  9. Variable de resultado secundaria

    Change from Baseline in WOMAC Stiffness Subscale

    Plazo Baseline, Week 72

  10. Variable de resultado secundaria

    Change from Baseline in WOMAC Total Score

    Plazo Baseline, Week 72

  11. Variable de resultado secundaria

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

    With exception of the Physical Functioning Domain Score

    Plazo Baseline, Week 72

  12. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  13. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  14. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  15. Variable de resultado secundaria

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

    Plazo Baseline, Week 72

  16. Variable de resultado secundaria

    Number of Participants with Allowed Concomitant Pain Medication

    Plazo Baseline, Week 72

  17. Variable de resultado secundaria

    Percent Change from Baseline in Total Cholesterol

    Plazo Baseline, Week 72

  18. Variable de resultado secundaria

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

    Plazo Predose through Week 48

Fechas

Fecha de inicio15 de septiembre de 2025 (real)
Finalización principal1 de abril de 2028 (estimada)
Finalización1 de mayo de 2028 (estimada)
Primera publicación4 de septiembre de 2025 (real)
Última actualización8 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

67 centros están en reclutamiento

Canada

CentroCiudadEstado o regiónEstado
Aggarwal and Associates LimitedBramptonEn reclutamiento
Diex Recherche Inc. Division JolietteJolietteEn reclutamiento
Your Research NetworkNiagara FallsEn reclutamiento
ALPHA Recherche CliniqueQuébecEn reclutamiento
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.QuébecEn reclutamiento
Alpha Recherche CliniqueQuébecEn reclutamiento
Bluewater Clinical Research Group Inc.SarniaEn reclutamiento
Winterberry Research Inc.Stoney CreekEn reclutamiento

China

CentroCiudadEstado o regiónEstado
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -TBaotouEn reclutamiento
Xuanwu Hospital Capital Medical UniversityBeijingEn reclutamiento
The Second Affiliated Hospital Chongqing Medical UniversityChongqingEn reclutamiento
The Fourth Affiliated Hospital of Harbin Medical UniversityHarbinEn reclutamiento
The Second People's Hospital of HefeiHefeiEn reclutamiento
Jinan Central HospitalJinanEn reclutamiento
The First Affiliated Hospital of Henan University of Science &TechnologyLuoyangEn reclutamiento
Nanjing First HospitalNanjingEn reclutamiento
Jiangsu Province HospitalNanjingEn reclutamiento
Nanjing Medical University - Nanjing Jiangning HospitalNanjingEn reclutamiento
Pingxiang People's HospitalPingxiangEn reclutamiento
The First Hospital of QinhuangdaoQinhuangdao ShiEn reclutamiento
Huashan Hospital, Fudan UniversityShanghaiEn reclutamiento
The First Affiliated Hospital of Shantou University Medical CollegeShantouEn reclutamiento
The University of Hong Kong-Shenzhen HospitalShenzhenEn reclutamiento
Taizhou Hospital of Zhejiang ProvinceTaizhouEn reclutamiento

Germany

CentroCiudadEstado o regiónEstado
Siteworks GmbH - BochumBochumActivo, sin reclutar
Klinische Forschung DresdenDresdenActivo, sin reclutar
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -THamburgActivo, sin reclutar
Klinische Forschung HamburgHamburgActivo, sin reclutar
Klinische Forschung Hannover-MitteHanoverActivo, sin reclutar
Siteworks GmbH - HannoverHanoverActivo, sin reclutar
Klinische Forschung KarlsruheKarlsruheActivo, sin reclutar
Siteworks - KarlsruheKarlsruheActivo, sin reclutar
AmBeNet GmbHLeipzigActivo, sin reclutar
CDG Studienambulanz HartardMünchenActivo, sin reclutar
Dedicated Research Site FutureMedsOffenbachActivo, sin reclutar
Private Practice - Dr. Jochen WalterRendsburgActivo, sin reclutar
Universitaetsklinikum WuerzburgWürzburgActivo, sin reclutar

Japan

CentroCiudadEstado o regiónEstado
Hamanomachi HospitalFukuokaEn reclutamiento
Fukuoka Wajiro HospitalFukuokaEn reclutamiento
Shimane University HospitalIzumoEn reclutamiento
Kariya Toyota General HospitalKariyaEn reclutamiento
Ando OrthopedicKawasakiEn reclutamiento
Tokyo Saiseikai Central HospitalMinatokuEn reclutamiento
Goto Orthopedic Surgery ClinicMiyazakiEn reclutamiento
Kato Orthopedic ClinicMoriokaEn reclutamiento
Japan Community Health Care Organization - Saitama Medical CenterSaitamaEn reclutamiento
Sapporo Maruyama Orthopedic HospitalSapporoEn reclutamiento
Masumoto Orthopedics ClinicSuginami CityEn reclutamiento

Mexico

CentroCiudadEstado o regiónEstado
Investigacion y Biomedicina de ChihuahuaChihuahua CityEn reclutamiento
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.Ciudad MaderoEn reclutamiento

En el registro figuran 38 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 8 de septiembre de 2026

    Centro eliminado

    8 sites removed (88 total)

    9688

  2. 6 de agosto de 2026

    Centro añadido

    1 site added (96 total)

    9596

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07153471