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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 800 مشارك88 موقعاً7 دول

الفئات

الجهاز العضلي الهيكلي51%الغدد الصمّاء والأيض42%المناعة والروماتيزم7%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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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.

ملخص

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.

الحالات

  • Osteoarthritis

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةSINGLE (1)
التجنيدمطلوب 800 مشارك

الجهة الراعية والمتعاونون

  • Eli Lilly and Company الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء Orforglipron

    Administered orally

  • دواء Placebo

    Administered orally

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    الإطار الزمني Baseline, Week 72

  2. مقياس النتيجة الثانوي

    Change from Baseline in the WOMAC Physical Function Subscale Score

    الإطار الزمني Baseline, Week 72

  3. مقياس النتيجة الثانوي

    Percent Change from Baseline in Body Weight

    الإطار الزمني Baseline, Week 72

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  5. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  6. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  7. مقياس النتيجة الثانوي

    Change from Baseline in Waist Circumference

    الإطار الزمني Baseline, Week 72

  8. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  9. مقياس النتيجة الثانوي

    Change from Baseline in WOMAC Stiffness Subscale

    الإطار الزمني Baseline, Week 72

  10. مقياس النتيجة الثانوي

    Change from Baseline in WOMAC Total Score

    الإطار الزمني Baseline, Week 72

  11. مقياس النتيجة الثانوي

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

    With exception of the Physical Functioning Domain Score

    الإطار الزمني Baseline, Week 72

  12. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  13. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  14. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  15. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 72

  16. مقياس النتيجة الثانوي

    Number of Participants with Allowed Concomitant Pain Medication

    الإطار الزمني Baseline, Week 72

  17. مقياس النتيجة الثانوي

    Percent Change from Baseline in Total Cholesterol

    الإطار الزمني Baseline, Week 72

  18. مقياس النتيجة الثانوي

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

    الإطار الزمني Predose through Week 48

التواريخ

تاريخ البدء15 سبتمبر 2025 (فعلي)
الإتمام الأولي1 أبريل 2028 (تقديري)
الإتمام1 مايو 2028 (تقديري)
أول نشر4 سبتمبر 2025 (فعلي)
آخر تحديث8 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

67 موقعاً قيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Aggarwal and Associates LimitedBramptonقيد التجنيد
Diex Recherche Inc. Division JolietteJolietteقيد التجنيد
Your Research NetworkNiagara Fallsقيد التجنيد
ALPHA Recherche CliniqueQuébecقيد التجنيد
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.Québecقيد التجنيد
Alpha Recherche CliniqueQuébecقيد التجنيد
Bluewater Clinical Research Group Inc.Sarniaقيد التجنيد
Winterberry Research Inc.Stoney Creekقيد التجنيد

China

المنشأةالمدينةالولاية أو المنطقةالحالة
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -TBaotouقيد التجنيد
Xuanwu Hospital Capital Medical UniversityBeijingقيد التجنيد
The Second Affiliated Hospital Chongqing Medical UniversityChongqingقيد التجنيد
The Fourth Affiliated Hospital of Harbin Medical UniversityHarbinقيد التجنيد
The Second People's Hospital of HefeiHefeiقيد التجنيد
Jinan Central HospitalJinanقيد التجنيد
The First Affiliated Hospital of Henan University of Science &TechnologyLuoyangقيد التجنيد
Nanjing First HospitalNanjingقيد التجنيد
Jiangsu Province HospitalNanjingقيد التجنيد
Nanjing Medical University - Nanjing Jiangning HospitalNanjingقيد التجنيد
Pingxiang People's HospitalPingxiangقيد التجنيد
The First Hospital of QinhuangdaoQinhuangdao Shiقيد التجنيد
Huashan Hospital, Fudan UniversityShanghaiقيد التجنيد
The First Affiliated Hospital of Shantou University Medical CollegeShantouقيد التجنيد
The University of Hong Kong-Shenzhen HospitalShenzhenقيد التجنيد
Taizhou Hospital of Zhejiang ProvinceTaizhouقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Siteworks GmbH - BochumBochumنشط، دون تجنيد
Klinische Forschung DresdenDresdenنشط، دون تجنيد
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -THamburgنشط، دون تجنيد
Klinische Forschung HamburgHamburgنشط، دون تجنيد
Klinische Forschung Hannover-MitteHanoverنشط، دون تجنيد
Siteworks GmbH - HannoverHanoverنشط، دون تجنيد
Klinische Forschung KarlsruheKarlsruheنشط، دون تجنيد
Siteworks - KarlsruheKarlsruheنشط، دون تجنيد
AmBeNet GmbHLeipzigنشط، دون تجنيد
CDG Studienambulanz HartardMünchenنشط، دون تجنيد
Dedicated Research Site FutureMedsOffenbachنشط، دون تجنيد
Private Practice - Dr. Jochen WalterRendsburgنشط، دون تجنيد
Universitaetsklinikum WuerzburgWürzburgنشط، دون تجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Hamanomachi HospitalFukuokaقيد التجنيد
Fukuoka Wajiro HospitalFukuokaقيد التجنيد
Shimane University HospitalIzumoقيد التجنيد
Kariya Toyota General HospitalKariyaقيد التجنيد
Ando OrthopedicKawasakiقيد التجنيد
Tokyo Saiseikai Central HospitalMinatokuقيد التجنيد
Goto Orthopedic Surgery ClinicMiyazakiقيد التجنيد
Kato Orthopedic ClinicMoriokaقيد التجنيد
Japan Community Health Care Organization - Saitama Medical CenterSaitamaقيد التجنيد
Sapporo Maruyama Orthopedic HospitalSapporoقيد التجنيد
Masumoto Orthopedics ClinicSuginami Cityقيد التجنيد

Mexico

المنشأةالمدينةالولاية أو المنطقةالحالة
Investigacion y Biomedicina de ChihuahuaChihuahua Cityقيد التجنيد
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.Ciudad Maderoقيد التجنيد

يُدرَج 38 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 8 سبتمبر 2026

    أُزيل موقع

    8 sites removed (88 total)

    9688

  2. 6 أغسطس 2026

    أُضيف موقع

    1 site added (96 total)

    9596

السجل: ClinicalTrials.gov · NCT########

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