OsteoarthritisPhase 3ENLIGHTEN-4NCT07353931
Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight
A Phase 3 study testing Eloralintide in people with Osteoarthritis and Overweight or Obesity, run by Eli Lilly and Company at 153 sites in 14 countries.
Trial summary
The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Overweight or Obesity
- What is being tested?
- Eloralintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 153 sitesin 14 countries
- Study dates
- 9 Feb 2026to May 2028
- Phase
- Phase 3
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 a stable body weight (less than 5% body weight change) for 90 days prior to 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 a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening)
- Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have an active knee infection
- Have had within 90 days prior to screening:
- heart attack
Show all 12Show fewer
- stroke
- coronary artery revascularization
- unstable angina, or
- hospitalization due to congestive heart failure
- Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
- Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Trial locations and contacts
153 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
153 sites in 14 countries
United States39 sites, 39 recruiting
- Recruiting
Medical Research Partners
Ammon, Idaho, 83406
208-681-9070
Joseph Moore
- Recruiting
JCCT - Juno Bellaire Site
Bellaire, Texas, 77401
713-779-5494
Rocio Harbison
- Recruiting
Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York, 11215
347-422-0317
Jorge Serje
- Recruiting
Rochester Clinical Research - Buffalo
Buffalo, New York, 14127
Rajiv Jain
- Recruiting
Skylight Health Research - Burlington
Burlington, Massachusetts, 01803
781-653-4281
Timothy McAlindon
- Recruiting
Charlottesville Medical Research
Charlottesville, Virginia, 22911
434-817-2442
James Clark
- Recruiting
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
773-275-3500
Manish Jain
- Recruiting
Skylight Health Research - Colorado Springs
Colorado Springs, Colorado, 80917
Renee Flick
- Recruiting
Orita Clinical Research
Decatur, Georgia, 30034
Ahmad Jingo
- Recruiting
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
197-277-7695
HARESH BOGHARA
- Recruiting
Qualmedica Research, LLC
Evansville, Indiana, 47715
812-205-2475
Moges Sisay
- Recruiting
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164
817-625-7733
Alex Guevara
- Recruiting
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708
714-988-2021
Mark Leibowitz
- Recruiting
Care Access - Houston
Houston, Texas, 77054
877-791-0656
Ali Bajwa
- Recruiting
Westside Center for Clinical Research
Jacksonville, Florida, 32205
904-693-1490
Matthew Braddock
- Recruiting
Paramount Clinical Research - Data Point Clinical Research
Kirkland, Washington, 98034
425-577-1107
Javier Nazar
- Recruiting
NYC Research INC
Long Island City, New York, 11106
516-574-9232
Anastasios Manessis
- Recruiting
Monroe Biomedical Research - Louisville
Louisville, Kentucky, 40213
502-515-5672
Harold Bays
- Recruiting
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206
877-791-0656
Michael Waters
- Recruiting
Elite Pain and Spine Institute - South Crimson Road
Mesa, Arizona, 85209
Zeeshan Malik
- Recruiting
AMR Clinical
Mobile, Alabama, 36608
251-414-1984
Harry Studdard
- Recruiting
AMR Clinical
Newton, Kansas, 67114
316-804-7304
Troy Holdeman
- Recruiting
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
602-788-3437
Joseph Lillo, DO
- Recruiting
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462
Cameron Olezene
- Recruiting
Care Access - Quincy
Quincy, Massachusetts, 02169
877-791-0656
Chih Chao Yang
- Recruiting
Rochester Clinical Research, LLC
Rochester, New York, 14609
585-288-0890
Patrick Connors
- Recruiting
VIP Trials
San Antonio, Texas, 78230
210-569-2672
Juan Garza
- Recruiting
Endeavor Clinical Trials
San Antonio, Texas, 78240
518-428-6859
Nitendra Agarwal
- Recruiting
Wolverine Clinical Trials
Santa Ana, California, 92706
714-617-2426
Behnam Khaleghi
- Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
210-545-4900
Michelle Welch
- Recruiting
AMR Clinical
South Jordan, Utah, 84095
Curtis Andrews
- Recruiting
Encompass Clinical Research
Spring Valley, California, 91978
619-660-9068
Hanid Audish
- Recruiting
Care Access - St. Petersburg
St. Petersburg, Florida, 33710
877-791-0656
Gigi Lefebvre
- Recruiting
Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona, 85712
520-404-0276
Nebojsa Skrepnik
- Recruiting
Central States Research
Tulsa, Oklahoma, 74136
918-645-5400
Sarah Land
- Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
925-930-7267
Helen Stacey
- Recruiting
Texas Valley Clinical Research
Weslaco, Texas, 78596
956-431-8090
Eduardo Luna
- Recruiting
Conquest Research
Winter Park, Florida, 32789
407-916-0060
Anand Patel
- Not yet recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
678-494-5735
Bram Wieskopf
China23 sites, 23 recruiting
- Recruiting
Beijing Ji Shui Tan Hospital
Beijing, 100035
Xiaoli Deng
- Recruiting
The First Afflilated Hospital of Bengbu Medical College
Bengbu, 233004
Xiaoyun Fan
- Recruiting
Jilin Province People's Hospital
Changchun, 130021
Guoping Jiang
- Recruiting
The Second Hospital of Jilin University
Changchun, 130041
Hanqing Cai
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
Wenfeng Xiao
- Recruiting
2nd Affiliated Hospital Chongqing Medical Universi
Chongqing, 400000
Mao Nie
- Recruiting
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, 310052
Haobo Wu
- Recruiting
The Second People's Hospital of Hefei
Hefei, 230011
86-13956099720
Jun Ye
- Recruiting
Jinan Central Hospital
Jinan, 250013
Nianrong Mi
- Recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003
86 13663884080
Xiaofei Shi
- Recruiting
Nanjing First Hospital
Nanjing, 210006
Qian Li
- Recruiting
Zhongda Hospital Southeast University
Nanjing, 210009
Jun Lu
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
18951762960
Yibing Lu
- Recruiting
Jiangsu Province Hospital
Nanjing, 210029
Hongwen Zhou
- Recruiting
The first affiliated hospital of Ningbo university
Ningbo, 315010
Xiudi Wu
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200023
Jie Zhao
- Recruiting
Zhongshan Hospital,Fudan University
Shanghai, 200032
Yunchao Shao
- Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
Yu Xue
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
Zhichun Liu
- Recruiting
Tianjin Hospital
Tianjin, 300211
13389987163
Jun Liu
- Recruiting
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, 315100
13806542929
Chaoming Wu
- Recruiting
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030
18672912727
Lingli Dong
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, 712000
18391081568
Fang Wang
Japan15 sites, 15 recruiting
- Recruiting
National Hospital Organization Chiba Medical Center
Chiba, 260-8606
81120023812
Akihiko Okawa
- Recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
81120023812
Arihiro Kiyosue
- Recruiting
Tokyo Asbo Clinic
Chūōku, 104-0031
81120023812
Akiyoshi Uchiyama
- Recruiting
Shin Komonji Hospital
Kitakyushu-Shi, 800-0057
81120023812
Motonori Sato
- Recruiting
Goto Orthopedic Surgery Clinic
Miyazaki, 880-0835
81120023812
Keisuke Goto
- Recruiting
Komagidai Clinic
Nagareyama, 270-0113
81120023812
Hideki Iizuka
- Recruiting
Fujigaki Clinic
Ōita, 870-0942
81120023812
Toru Fujigaki
- Recruiting
Saitama City Hospital
Saitama, 336-8522
81120023812
Kentaro Takeda
- Recruiting
Ibaraki Seinan Medical Center Hospital
Sashima, 306-0433
81120023812
Masafumi Uesugi
- Recruiting
Ogura Orthopedics Surgery
Sendai, 980-0011
81120023812
Ken Ogura
- Recruiting
Katsura Garden Orthopedics
Sendai, 981-3134
81120023812
Masakazu Kogawa
- Recruiting
Ooimachi Orthopedic Surgery and surgery Clinic
Shinagawa-ku Tokyo, 140-0014
81120023812
Omata Masanari
- Recruiting
Masumoto Orthopedics Clinic
Suginami City, 167-0051
81120023812
Kou Masumoto
- Recruiting
National Hospital Organization Toyohashi Medical Center
Toyohashi, 440-8510
81120023812
Yasuhiro Shibata
- Recruiting
Yamagata Tokushukai Hospital
Yamagata, 990-0834
81120023812
Eita Togashi
Argentina14 sites, 14 recruiting
- Not yet recruiting
Centro Privado de Medicina Familiar / Mindout Research
Buenos Aires, 1417
541145023759
Leonardo Naftal
- Not yet recruiting
CARDIAMET Investigaciones Médicas
Buenos Aires, C1014ACP
5491169139814
Virginia Durigan
- Not yet recruiting
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO
541143720308
Patricio Tate
- Not yet recruiting
Stat Research S.A.
Buenos Aires, C1023AAB
54 9 1167063598
ALEJANDRO ARROYO
- Not yet recruiting
Centro Médico Arsema
Buenos Aires, C1427CCL
1124691447
Federico Ariel
- Not yet recruiting
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152
543415593898
Juan Escalante
- Not yet recruiting
INECO Neurociencias Oroño
Rosario, 2000
3415597777
Florencia Garavelli
- Not yet recruiting
Instituto Especialidades de la Salud Rosario
Rosario, 2000
341- 6011549
Julieta Gentiletti
- Not yet recruiting
Medicina Reumatológica
San Fernando, 1646
541169956547
Maria Cusa
- Not yet recruiting
Instituto de Alta Complejidad San Isidro
San Isidro, 1642
54 9 1164620494
Maria Lazaro
- Not yet recruiting
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, 5400
2644211086
Rodolfo Pardo Hidalgo
- Not yet recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL
54-9-381-5537820
Walter Spindler
- Not yet recruiting
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, 4000
543814301098
Luciana Gonzalez Lucero
- Not yet recruiting
Go Centro Medico San Nicolás
San Nicolás, 2900
5493364571637
Paulina Lanchiotti
Belgium8 sites, 8 recruiting
- Recruiting
Antwerp University Hospital
Edegem, 2650
3238213478
eveline dirinck
- Recruiting
Reuma Clinic, Locatie Jaarbeurslaan
Genk, 3600
089362977
Johan Vanhoof
- Recruiting
UZ Gent
Ghent, 9000
+3293320582
Ruth Wittoek
- Recruiting
Kormont
Kluisbergen, 9690
32 496 376259
Klaas Vercruysse
- Recruiting
UZ Leuven
Leuven, 3000
+3216342541
Kurt de Vlam
- Recruiting
Meclinas
Mechelen, 2800
003215792797
Julie Casaer
- Not yet recruiting
ZNA Jan Palfijn
Merksem, 2170
+326402851
Alla Ishchenko
- Not yet recruiting
Medisch Centrum Latem (Hip Clinic) - Algemeen Ziekenhuis Maria Middelares Location
Sint-Martens-Latem, 9830
09 220 88 68
Pieter Vansintjan
Germany8 sites, 8 recruiting
- Recruiting
Siteworks GmbH - Bochum
Bochum, 44787
+49 234 60144350
Annemone Koechel
- Recruiting
Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann
Bünde, 32257
0049522314438
Kai Koenemann
- Recruiting
StudyPoint Duisburg
Duisburg, 47269
+491725448897
Matthias Kuenster
- Recruiting
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
Hamburg, 20095
004940323103166
Andrea Everding
- Recruiting
Siteworks GmbH - Zentrum für klinische Studien Karlsruhe
Karlsruhe, 76137
004951151524740
Niels-Christian Hoellger
- Recruiting
AmBeNet GmbH
Leipzig, 04107
4934196276326
Hans-Detlev Stahl
- Recruiting
CDG Studienambulanz Hartard
München, 80809
00498935819977
Manfred Hartard
- Recruiting
FutureMeds Offenbach
Offenbach, 63065
0049 69 247433849
Christel Contzen
South Korea8 sites, 8 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Ki Cheor Bae
- Recruiting
Boramae Medical Center
Dongjak-gu, 07061
Moonjong Chang
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hyuk-Soo Han
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
+82222282180
Sunghwan Kim
- Recruiting
Asan Medical Center
Seoul, 05505
+82-2-3010-3897
JONG-MIN KIM
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
010-9044-5228
yong in
- Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
82-10-8762-7089
Joongil Kim
- Recruiting
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765
SEOK JUNG KIM
United Kingdom8 sites, 8 recruiting
- Recruiting
Velocity Clinical Research, Bristol
Bristol, BS8 2RA
+44 1174 611208
Kirsten Peacey
- Recruiting
FutureMeds Glasgow - CPS Research
Glasgow, G20 7BE
0141 9467888
Kristen Laing
- Recruiting
FutureMeds - London
London, NW10 2PB
07858413118
Pembe Ozunlu
- Recruiting
Futuremeds-Newcastle
Newcastle, NE6 1SG
William Aspinall
- Recruiting
Atlantic Medical
Penzance, TR18 3DX
Alex Dewdney
- Recruiting
Woodstock Bower Surgery
Rotherham, S61 1AH
07551985998
Shahbaz Ali
- Recruiting
Panthera Biopartners - Sheffield
Sheffield, S2 5FX
01143503730
Hannah Collins
- Recruiting
Panthera Clinic - York
York, YO24 4LJ
01772 237822
Mahadev Ramjee
Canada7 sites, 7 recruiting
- Recruiting
Apex Trials
Guelph, N1G 0B4
519-341-3367
Ken Woo
- Not yet recruiting
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, G1V 4K5
418 650-2661
Louis Bessette
- Recruiting
Diex Recherche Inc. Division Quebec
Québec, G1V 4T3
5144773439
Caroline Rheaume
- Recruiting
Stouffville Medical Research Institute Inc.
Stouffville, L4A 1H2
(905) 640-3100
Nima Mirtorabi
- Recruiting
Maple Leaf Research
Toronto, M5G 1K2
Mona Loutfy
- Recruiting
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, M9V 4B4
6473442020
Anil Gupta
- Recruiting
Diex Recherche Inc. Division Victoriaville
Victoriaville, G6P 3Z8
819-260-1172
Eve Betit
Taiwan7 sites, 7 recruiting
- Recruiting
Changhua Christian Hospital
Changhua County, 50006
Ing-Lin Chang
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301
8860975056125
Ying-Chou Chen
- Recruiting
China Medical University Hospital
Taichung, 404332
886923832500
Wen-Yuan Lin
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
06-2353535
Po-Ting Wu
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Chia-Wen Lu
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Chi-Ching Chang
- Recruiting
Tri-Service General Hospital
Taipei, 114
88687927135
Yu-Hsiu Chen
Brazil6 sites
- Suspended
Centro de Pesquisa Sao Lucas
Campinas, 13060-803
- Suspended
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180
- Suspended
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, 01228-000
- Suspended
INTEGRA - Pesquisa Clínica e Infusões
São Paulo, 04039-002
- Suspended
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
- Suspended
Hospital das Clinicas FMUSP
São Paulo, 05403-000
Czechia5 sites, 5 recruiting
- Recruiting
Pratia Brno
Brno, 602 00
+420515550902
Simona Pappova
- Recruiting
Revmatologie.s.r.o.
Brno, 63800
+42545214556
Leona Prochazkova
- Recruiting
INREA s.r.o.
Ostrava, 70300
420776153321
Martina Malcova
- Recruiting
Pratia Pardubice a.s.
Pardubice, 53002
777691225
Marcela Svobodova
- Recruiting
Medical Plus Research
Uherské Hradiště, 686 01
Eva Dokoupilova
Denmark3 sites, 3 recruiting
- Recruiting
Sanos Clinic - Nordjylland
Gandrup, 9362
Janani Umachanger
- Recruiting
Sanos Clinic
Herlev, 2730
Linda Bracher
- Recruiting
Sanos Clinic - Syddanmark
Vejle, 7100
SIDSEL BOLL
Puerto Rico2 sites, 2 recruiting
- Recruiting
Dorado Medical Complex
Dorado, 00646
787-278-1576
Luis Pagan-Cardona
- Recruiting
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917
17877268396
Karina Vila-Rivera
About this study
Official title: A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)
The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.
- Conditions
- Osteoarthritis, Overweight or Obesity
- Being tested
- Eloralintide, Placebo
- Medical subject headings
- Osteoarthritis, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EloralintideDrug
Also called LY3841136
Administered SC
PlaceboDrug
Placebo administered SC
| Study group | Role | What they receive |
|---|---|---|
| Eloralintide (YOA1) | Experimental | Participants will receive eloralintide subcutaneously (SC) Receives: Drug: Eloralintide |
| Placebo (YOA1) | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
| Eloralintide (YOA2) | Experimental | Participants will receive eloralintide SC Receives: Drug: Eloralintide |
| Placebo (YOA2) | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 64
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Change from Baseline in the WOMAC Pain Subscale Score
Measured: Baseline, Week 64
Secondary outcomes (24)
Change from Baseline in Systolic Blood Pressure (SBP)
Change from Baseline in SBP
Measured: Baseline, Week 64
Percent Change from Baseline in Triglycerides
Percent Change in Baseline in Triglycerides
Measured: Baseline, Week 64
Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score
Change from Baseline in SF-36 v2 Score
Measured: Baseline, Week 64
Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP)
Percent Change from Baseline in hsCRP
Measured: Baseline, Week 64
Change from Baseline in the WOMAC Physical Function Subscale Score
Change from Baseline in the WOMAC Physical Function Subscale Score
Measured: Baseline, Week 40, Week 64
Change from Baseline WOMAC Pain Subscale Score
Change from Baseline WOMAC Pain Subscale Score
Measured: Baseline, Week 40
Change from Baseline in Distance Walked During the 6-Minute Walk Test
Change from Baseline in Distance Walked During the 6-Minute Walk Test
Measured: Baseline, Week 64
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in BMI
Measured: Baseline, Week 64
Change in Medication Use
Change in Medication Use
Measured: Baseline, Week 64
Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score
Change from Baseline in SF-36v2 Acute Form Domain Scores With Exception of the Physical Functioning Domain Score
Measured: Baseline, Week 64
Change from Baseline in Health Status EQ-5D-5L Health State Utility
Change from Baseline in Health Status EQ-5D-5L Health State Utility
Measured: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Percent Change from Baseline in Fasting Insulin
Measured: Baseline, Week 64
Percent Change from Baseline in Total Cholesterol
Percent Change from Baseline in Total Cholesterol
Measured: Baseline, Week 64
Change from Baseline in Waist Circumference
Change from Baseline in Waist Circumference
Measured: Baseline, Week 64
Percent Change from Baseline in Hemoglobin A1c (HbA1c)
Percent Change from Baseline in HbA1c
Measured: Baseline, Week 64
Change from Baseline in WOMAC Stiffness Subscale Score
Change from Baseline in WOMAC Stiffness Subscale Score
Measured: Baseline, Week 64
Change from Baseline in WOMAC Total Score
Change from Baseline in WOMAC Total Score
Measured: Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Pain
Achievement of Improved Categorical Shift in PGIS - Target Knee Pain
Measured: Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function
Achievement of Improved Categorical Shift in PGIS - Target Knee Function
Measured: Baseline, Week 64
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score
Change from Baseline in API-NRS Score
Measured: Baseline, Week 64
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score
Change from Baseline in WPI-NRS Score
Measured: Baseline, Week 64
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax, ss)
PK: Cmax, ss
Measured: Baseline through Week 64
PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-T)ss)
PK: AUC(0-T)ss
Measured: Baseline through Week 64
Number of Participants with Allowed Concomitant Pain Medication
Number of Participants with Allowed Concomitant Pain Medication
Measured: Baseline, Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start9 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353931
- Sponsor's protocol ID
- 27761
- Other IDs
- 2025-523768-19-00, J3R-MC-YDAN, J3R-MC-YOA1, J3R-MC-YOA2, 2025
- Acronym
- ENLIGHTEN-4
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.