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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati88 centri7 paesi

Categorie

Apparato muscoloscheletrico51%Endocrino e metabolico42%Immunologia e reumatologia7%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Osteoarthritis

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoSINGLE (1)
Arruolamento800 partecipanti ricercati

Sponsor e collaboratori

  • Eli Lilly and Company Sponsor

Bracci e interventi

  • 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

Interventi

  • Farmaco Orforglipron

    Administered orally

  • Farmaco Placebo

    Administered orally

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale Baseline, Week 72

  2. Esito secondario

    Change from Baseline in the WOMAC Physical Function Subscale Score

    Orizzonte temporale Baseline, Week 72

  3. Esito secondario

    Percent Change from Baseline in Body Weight

    Orizzonte temporale Baseline, Week 72

  4. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  5. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  6. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  7. Esito secondario

    Change from Baseline in Waist Circumference

    Orizzonte temporale Baseline, Week 72

  8. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  9. Esito secondario

    Change from Baseline in WOMAC Stiffness Subscale

    Orizzonte temporale Baseline, Week 72

  10. Esito secondario

    Change from Baseline in WOMAC Total Score

    Orizzonte temporale Baseline, Week 72

  11. Esito secondario

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

    With exception of the Physical Functioning Domain Score

    Orizzonte temporale Baseline, Week 72

  12. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  13. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  14. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  15. Esito secondario

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

    Orizzonte temporale Baseline, Week 72

  16. Esito secondario

    Number of Participants with Allowed Concomitant Pain Medication

    Orizzonte temporale Baseline, Week 72

  17. Esito secondario

    Percent Change from Baseline in Total Cholesterol

    Orizzonte temporale Baseline, Week 72

  18. Esito secondario

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

    Orizzonte temporale Predose through Week 48

Date

Data di inizio15 settembre 2025 (effettiva)
Conclusione primaria1 aprile 2028 (stimata)
Conclusione1 maggio 2028 (stimata)
Prima pubblicazione4 settembre 2025 (effettiva)
Ultimo aggiornamento8 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

67 centri stanno reclutando

Canada

StrutturaCittàStato o regioneStato
Aggarwal and Associates LimitedBramptonIn reclutamento
Diex Recherche Inc. Division JolietteJolietteIn reclutamento
Your Research NetworkNiagara FallsIn reclutamento
ALPHA Recherche CliniqueQuébecIn reclutamento
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.QuébecIn reclutamento
Alpha Recherche CliniqueQuébecIn reclutamento
Bluewater Clinical Research Group Inc.SarniaIn reclutamento
Winterberry Research Inc.Stoney CreekIn reclutamento

China

StrutturaCittàStato o regioneStato
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -TBaotouIn reclutamento
Xuanwu Hospital Capital Medical UniversityBeijingIn reclutamento
The Second Affiliated Hospital Chongqing Medical UniversityChongqingIn reclutamento
The Fourth Affiliated Hospital of Harbin Medical UniversityHarbinIn reclutamento
The Second People's Hospital of HefeiHefeiIn reclutamento
Jinan Central HospitalJinanIn reclutamento
The First Affiliated Hospital of Henan University of Science &TechnologyLuoyangIn reclutamento
Nanjing First HospitalNanjingIn reclutamento
Jiangsu Province HospitalNanjingIn reclutamento
Nanjing Medical University - Nanjing Jiangning HospitalNanjingIn reclutamento
Pingxiang People's HospitalPingxiangIn reclutamento
The First Hospital of QinhuangdaoQinhuangdao ShiIn reclutamento
Huashan Hospital, Fudan UniversityShanghaiIn reclutamento
The First Affiliated Hospital of Shantou University Medical CollegeShantouIn reclutamento
The University of Hong Kong-Shenzhen HospitalShenzhenIn reclutamento
Taizhou Hospital of Zhejiang ProvinceTaizhouIn reclutamento

Germany

StrutturaCittàStato o regioneStato
Siteworks GmbH - BochumBochumAttivo, non in reclutamento
Klinische Forschung DresdenDresdenAttivo, non in reclutamento
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -THamburgAttivo, non in reclutamento
Klinische Forschung HamburgHamburgAttivo, non in reclutamento
Klinische Forschung Hannover-MitteHanoverAttivo, non in reclutamento
Siteworks GmbH - HannoverHanoverAttivo, non in reclutamento
Klinische Forschung KarlsruheKarlsruheAttivo, non in reclutamento
Siteworks - KarlsruheKarlsruheAttivo, non in reclutamento
AmBeNet GmbHLeipzigAttivo, non in reclutamento
CDG Studienambulanz HartardMünchenAttivo, non in reclutamento
Dedicated Research Site FutureMedsOffenbachAttivo, non in reclutamento
Private Practice - Dr. Jochen WalterRendsburgAttivo, non in reclutamento
Universitaetsklinikum WuerzburgWürzburgAttivo, non in reclutamento

Japan

StrutturaCittàStato o regioneStato
Hamanomachi HospitalFukuokaIn reclutamento
Fukuoka Wajiro HospitalFukuokaIn reclutamento
Shimane University HospitalIzumoIn reclutamento
Kariya Toyota General HospitalKariyaIn reclutamento
Ando OrthopedicKawasakiIn reclutamento
Tokyo Saiseikai Central HospitalMinatokuIn reclutamento
Goto Orthopedic Surgery ClinicMiyazakiIn reclutamento
Kato Orthopedic ClinicMoriokaIn reclutamento
Japan Community Health Care Organization - Saitama Medical CenterSaitamaIn reclutamento
Sapporo Maruyama Orthopedic HospitalSapporoIn reclutamento
Masumoto Orthopedics ClinicSuginami CityIn reclutamento

Mexico

StrutturaCittàStato o regioneStato
Investigacion y Biomedicina de ChihuahuaChihuahua CityIn reclutamento
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.Ciudad MaderoIn reclutamento

Nella scheda del registro sono indicati altri 38 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 8 settembre 2026

    Centro rimosso

    8 sites removed (88 total)

    9688

  2. 6 agosto 2026

    Centro aggiunto

    1 site added (96 total)

    9596

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

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