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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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.
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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…

Phase 3800 Teilnehmende gesucht88 Studienzentren7 Länder

Kategorien

Bewegungsapparat51%Endokrin und metabolisch42%Immunologie und Rheumatologie7%

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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.

Zusammenfassung

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.

Erkrankungen

  • Osteoarthritis

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungSINGLE (1)
Teilnahme800 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Eli Lilly and Company Sponsor

Studienarme und Interventionen

  • 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

Interventionen

  • Arzneimittel Orforglipron

    Administered orally

  • Arzneimittel Placebo

    Administered orally

Endpunkte

  1. Primärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  2. Sekundärer Endpunkt

    Change from Baseline in the WOMAC Physical Function Subscale Score

    Zeitrahmen Baseline, Week 72

  3. Sekundärer Endpunkt

    Percent Change from Baseline in Body Weight

    Zeitrahmen Baseline, Week 72

  4. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  5. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  6. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  7. Sekundärer Endpunkt

    Change from Baseline in Waist Circumference

    Zeitrahmen Baseline, Week 72

  8. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  9. Sekundärer Endpunkt

    Change from Baseline in WOMAC Stiffness Subscale

    Zeitrahmen Baseline, Week 72

  10. Sekundärer Endpunkt

    Change from Baseline in WOMAC Total Score

    Zeitrahmen Baseline, Week 72

  11. Sekundärer Endpunkt

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

    With exception of the Physical Functioning Domain Score

    Zeitrahmen Baseline, Week 72

  12. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  13. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  14. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  15. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 72

  16. Sekundärer Endpunkt

    Number of Participants with Allowed Concomitant Pain Medication

    Zeitrahmen Baseline, Week 72

  17. Sekundärer Endpunkt

    Percent Change from Baseline in Total Cholesterol

    Zeitrahmen Baseline, Week 72

  18. Sekundärer Endpunkt

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

    Zeitrahmen Predose through Week 48

Daten

Startdatum15. September 2025 (tatsächlich)
Primärer Abschluss1. April 2028 (geschätzt)
Abschluss1. Mai 2028 (geschätzt)
Erstveröffentlichung4. September 2025 (tatsächlich)
Zuletzt aktualisiert8. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

67 Studienzentren rekrutieren

Canada

EinrichtungStadtBundesland oder RegionStatus
Aggarwal and Associates LimitedBramptonRekrutiert
Diex Recherche Inc. Division JolietteJolietteRekrutiert
Your Research NetworkNiagara FallsRekrutiert
ALPHA Recherche CliniqueQuébecRekrutiert
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.QuébecRekrutiert
Alpha Recherche CliniqueQuébecRekrutiert
Bluewater Clinical Research Group Inc.SarniaRekrutiert
Winterberry Research Inc.Stoney CreekRekrutiert

China

EinrichtungStadtBundesland oder RegionStatus
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -TBaotouRekrutiert
Xuanwu Hospital Capital Medical UniversityBeijingRekrutiert
The Second Affiliated Hospital Chongqing Medical UniversityChongqingRekrutiert
The Fourth Affiliated Hospital of Harbin Medical UniversityHarbinRekrutiert
The Second People's Hospital of HefeiHefeiRekrutiert
Jinan Central HospitalJinanRekrutiert
The First Affiliated Hospital of Henan University of Science &TechnologyLuoyangRekrutiert
Nanjing First HospitalNanjingRekrutiert
Jiangsu Province HospitalNanjingRekrutiert
Nanjing Medical University - Nanjing Jiangning HospitalNanjingRekrutiert
Pingxiang People's HospitalPingxiangRekrutiert
The First Hospital of QinhuangdaoQinhuangdao ShiRekrutiert
Huashan Hospital, Fudan UniversityShanghaiRekrutiert
The First Affiliated Hospital of Shantou University Medical CollegeShantouRekrutiert
The University of Hong Kong-Shenzhen HospitalShenzhenRekrutiert
Taizhou Hospital of Zhejiang ProvinceTaizhouRekrutiert

Germany

EinrichtungStadtBundesland oder RegionStatus
Siteworks GmbH - BochumBochumAktiv, rekrutiert nicht
Klinische Forschung DresdenDresdenAktiv, rekrutiert nicht
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -THamburgAktiv, rekrutiert nicht
Klinische Forschung HamburgHamburgAktiv, rekrutiert nicht
Klinische Forschung Hannover-MitteHanoverAktiv, rekrutiert nicht
Siteworks GmbH - HannoverHanoverAktiv, rekrutiert nicht
Klinische Forschung KarlsruheKarlsruheAktiv, rekrutiert nicht
Siteworks - KarlsruheKarlsruheAktiv, rekrutiert nicht
AmBeNet GmbHLeipzigAktiv, rekrutiert nicht
CDG Studienambulanz HartardMünchenAktiv, rekrutiert nicht
Dedicated Research Site FutureMedsOffenbachAktiv, rekrutiert nicht
Private Practice - Dr. Jochen WalterRendsburgAktiv, rekrutiert nicht
Universitaetsklinikum WuerzburgWürzburgAktiv, rekrutiert nicht

Japan

EinrichtungStadtBundesland oder RegionStatus
Hamanomachi HospitalFukuokaRekrutiert
Fukuoka Wajiro HospitalFukuokaRekrutiert
Shimane University HospitalIzumoRekrutiert
Kariya Toyota General HospitalKariyaRekrutiert
Ando OrthopedicKawasakiRekrutiert
Tokyo Saiseikai Central HospitalMinatokuRekrutiert
Goto Orthopedic Surgery ClinicMiyazakiRekrutiert
Kato Orthopedic ClinicMoriokaRekrutiert
Japan Community Health Care Organization - Saitama Medical CenterSaitamaRekrutiert
Sapporo Maruyama Orthopedic HospitalSapporoRekrutiert
Masumoto Orthopedics ClinicSuginami CityRekrutiert

Mexico

EinrichtungStadtBundesland oder RegionStatus
Investigacion y Biomedicina de ChihuahuaChihuahua CityRekrutiert
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.Ciudad MaderoRekrutiert

38 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 8. September 2026

    Studienzentrum entfernt

    8 sites removed (88 total)

    9688

  2. 6. August 2026

    Studienzentrum hinzugefügt

    1 site added (96 total)

    9596

Register: ClinicalTrials.gov · NCT########

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