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

2025-522631-34-00 Protocol J2A-MC-GZPT Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 14 Jan 2026 · Status Ongoing, recruiting · 2 EU/EEA countries · 22 sites · Protocol J2A-MC-GZPT

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 800
Countries 2
Sites 22

Osteoarthritis

To demonstrate that orforglipron once daily maximum tolerated dose (MTD) is superior to placebo for change in the WOMAC pain subscale score.

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
14 Jan 2026 → ongoing
Decision date (initial)
2025-12-29
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Therapy, Pharmacokinetic, Pharmacodynamic, Efficacy

To demonstrate that orforglipron once daily maximum tolerated dose (MTD) is superior to placebo for change in the WOMAC pain subscale score.

Conditions and MedDRA coding

Osteoarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Have obesity or overweight
  2. Have tried to lose weight through diet at least once but were not successful
  3. Have osteoarthritis of the knee
  4. Be willing to stop certain pain medications during the entire study

Exclusion criteria 5

  1. Have taken a glucagon-like peptide-1 (GLP-1) medication within 180 days or other weight loss medications in the 90 days before screening.
  2. Have type 1 or type 2 diabetes or another type of diabetes
  3. Be taking a medicine to lower blood sugar in the 90 days before screening.
  4. Have had a recent heart attack, stroke or other heart event in the 90 days before screening
  5. Have had surgery for obesity or plan to have one in the next 18 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Orforglipron

PRD12263027 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD12263032 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD12263029 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD12263030 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD12263031 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD12263028 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 7

OrganisationCity, countryDuties
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Data management
Clinical Ink Inc.
ORG-100042433
 Winston Salem, United States Data management
PPD International Holdings LLC
ORG-100007655
 Zaventem, Belgium Laboratory analysis
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States E-data capture
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other
Pharmaceutical Product Development LLC
ORG-100016999
 Highland Heights, United States Laboratory analysis
Iqvia Biotech LLC
ORG-100008704
 Durham, United States On site monitoring

Locations

2 EU/EEA countries · 22 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ongoing, recruiting 115 14
Spain Ongoing, recruiting 65 8
Rest of world
India, Canada, China, United States, Japan, Mexico
 — 620 —

Investigational sites

Germany

14 sites · Ongoing, recruiting
Klinische Forschung Hannover-Mitte GmbH
N/A, Schillerstrasse 30, Mitte, Hanover
Klinische Forschung Karlsruhe GmbH
N/A, Rueppurrer Strasse 52, Suedstadt, Karlsruhe
Klinische Forschung Berlin-Mitte GmbH
N/A, Georgenstrasse 24, Mitte, Berlin
Siteworks GmbH
N/A, Niemeyerstrasse 21, Linden-Mitte, Hanover
CDG Studienambulanz Hartard
N/A, Helene-Mayer-Ring 14, Bayern, München
FutureMeds GmbH
N/A, Platz Der Deutschen Einheit 4, 63065, Offenbach Am Main
Siteworks GmbH
N/A, Eppelheimer Strasse 8, Weststadt, Heidelberg
Siteworks GmbH
N/A, Grabenstrasse 12, Innenstadt, Bochum
Private Practice - Dr. Jochen Walter
N/A, Hollesenstrasse 27a, 24768, Rendsburg
Klinische Forschung Hamburg GmbH
N/A, Hoheluftchaussee 18, Hoheluft-Ost, Hamburg
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
N/A, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Koenig-Ludwig-Haus Orthopaedische Klinik
Osteologie / Muskuloskelettales Zentrum, Brettreichstrasse 11, Frauenland, Wuerzburg
Klinische Forschung Dresden
N/A, Prager Strasse 10, 01069, Dresden

Spain

8 sites · Ongoing, recruiting
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Endocrinology and Nutrition, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital Quironsalud Infanta Luisa
Endocrinology, Calle De San Jacinto 87, 41010, Sevilla
Instituto Medico Quirurgico San Rafael S.A.
Endocrinology, Poboado Nucleo Rural La Jubias 82, 15006, A Coruna
Hospital Universitario Marques De Valdecilla
Endocrinology, Diabetes and Nutrition, Avenida Valdecilla Sn, 39008, Santander
Clinica Gaias Santiago
Rheumatology, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Hospital Quironsalud Malaga
Endocrinology and Nutrition, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitari Vall D Hebron
Endocrinology and Nutrition, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valladolid
Endocrinology and Nutrition, Avenida Ramon Y Cajal 3, 47003, Valladolid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2026-01-14 2026-01-16
Spain 2026-01-15 2026-01-21

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Master protocol_2025-522631-34-00_orforglipron_CTIS_Redacted b
Protocol (for publication) D1_Protocol ISA GZT1_2025-522631-34-00_Initial 1.0
Protocol (for publication) D1_Protocol ISA GZT2_2025-522631-34-00_Initial 1.0
Protocol (for publication) D4_Patient facing documents_copyright statement 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Site specific recruitment material_Seefried 2
Recruitment arrangements (for publication) K2_Recruitment and retention material_site specific recruitment text_Everding_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Redacted 1.2
Recruitment arrangements (for publication) K2_Recruitment material_Doctor Referral Letter 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Doctor to Patient Letter_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1.2
Recruitment arrangements (for publication) K2_Recruitment material_Poster 1.2
Recruitment arrangements (for publication) K2_Recruitment material_Prescreener_Mehrwald_Heymer_Wagner_Reimer_Tischner 1
Recruitment arrangements (for publication) K2_Recruitment material_Schweigepflichentbindung_Hoellger 1
Recruitment arrangements (for publication) K2_Recruitment material_Schweigepflichentbindung_Koechel 1
Recruitment arrangements (for publication) K2_Recruitment material_Schweigepflichentbindung_Lengler 1
Recruitment arrangements (for publication) K2_Recruitment material_site recruitment text_Mehrwald_Heymer_Wagner_Reimer_Tischner_Redacted 2
Recruitment arrangements (for publication) K2_Recruitment material_site specific recruitment text_Contzen_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_site specific recruitment text_Koechel_Hoellger_Lengler 1
Recruitment arrangements (for publication) K2_Recruitment material_site specific recruitment text_Stahl_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_site specific recruitment text_Walter 1
Recruitment arrangements (for publication) K2_Recruitment material_Trialbee_Digital Marketing Content 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Trialbee_Global Privacy Policy 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Trialbee_Overview Supplementary Information 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Trialbee_Seconday Assessment and Communication_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Trialbee_Self Assessment 1.1
Recruitment arrangements (for publication) K2_Recruitment materials_GZPT_Brochure_Master_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment materials_GZPT_Flyer_Master 1
Recruitment arrangements (for publication) K2_Recruitment materials_GZPT_Letter-Doctor-Referral_Master 1
Recruitment arrangements (for publication) K2_Recruitment materials_GZPT_Letter-Doctor-to-Patient_Master_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment materials_GZPT_Poster_Master 1
Recruitment arrangements (for publication) K2_Recruitment materials_GZPT_Study-Connect-Participant_Master 1
Recruitment arrangements (for publication) K2_Recruitment materials_Supportive-Partner-Guide_Master 1
Recruitment arrangements (for publication) K2_Site Specific Recruitment Material_Broschure_Hartard 1.0
Recruitment arrangements (for publication) K2_Site Specific Recruitment Material_Newsletter_Hartard 1.0
Recruitment arrangements (for publication) K2_Site Specific Recruitment Material_Poster_Hartard 1.0
Recruitment arrangements (for publication) K2_Site Specific Recruitment Material_Questionnaire_Hartard 1.0
Recruitment arrangements (for publication) K2_Trialbee_Digital_Marketing_Content 1.0
Recruitment arrangements (for publication) K2_Trialbee_Global_Privacy_Policy 1.0
Recruitment arrangements (for publication) K2_Trialbee_Overview_Supplementary_Information 1.0
Recruitment arrangements (for publication) K2_Trialbee_Secondary_Assessment_Redacted 1.0
Recruitment arrangements (for publication) K2_Trialbee_Self Assessment 1.0
Subject information and informed consent form (for publication) L1_Pregnant Partner ICF_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum ICF_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Adenda Estudio Opcional_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Adenda preseleccion 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Adenda preseleccion_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Confidentiality Notice for TLC 1
Subject information and informed consent form (for publication) L1_SIS and ICF_main ICF_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activity_Addendum ICF_redacted 1.2
Subject information and informed consent form (for publication) L2_Other subject information material_GZPT_Study-Guide_Master_Redacted 1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Participant Contact Card 1
Synopsis of the protocol (for publication) D1_Protocol Synopsis GZPT_2025-522631-34-00_Redacted b
Synopsis of the protocol (for publication) D1_Protocol Synopsis ISA GZT1_2025-522631-34-00_Redacted 1
Synopsis of the protocol (for publication) D1_Protocol Synopsis ISA GZT2_2025-522631-34-00_Redacted 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_GZT1_2025-522631-34-00 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_GZT2_2025-522631-34-00 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_Master_2025-522631-34-00_Redacted b

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-08-29 Spain Acceptable
2025-12-22
 2025-12-29
2 SUBSTANTIAL MODIFICATION SM-1 2026-02-20 Spain Acceptable
2026-04-27
 2026-05-04

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