Clinical trial • Phase III • Musculoskeletal

ORFORGLIPRON HEMICALCIUM for Osteoarthritis of the knee

Phase III trial of ORFORGLIPRON HEMICALCIUM for Osteoarthritis of the knee.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Osteoarthritis of the knee
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-08-2025
First CTIS Authorization Date
29-12-2025

Trial design

Randomised, placebo to match ly (placebo control); dose/schedule not specified in the record Phase III trial in Germany, Spain.

Randomised
Yes
Comparator
Placebo to match LY (placebo control); dose/schedule not specified in the record
Target Sample Size
620

Eligibility

Recruits 620 adults.

Inclusion criteria

  • {"criterion_text":"- Have obesity or overweight\n- Have tried to lose weight through diet at least once but were not successful\n- Have osteoarthritis of the knee\n- Be willing to stop certain pain medications during the entire study"}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score","definition_or_measurement_approach":"To demonstrate that orforglipron once daily maximum tolerated dose (MTD) is superior to placebo for change in the WOMAC pain subscale score (change from baseline in WOMAC Pain subscale)."}

Recruitment

Digital Remote Recruitment
True, digital/remote methods include Trialbee digital marketing content, Trialbee self-assessment and online Study-Connect participant materials referenced in recruitment documents.
Planned Sample Size
620
Recruitment Window Months
29
Consent Approach
Subject information sheets and informed consent forms are provided (documents listed such as L1_SIS and ICF_Main_Redacted and related addenda). The record does not provide explicit details on assent or age-specific consent processes or the languages of the consent documents.

Methods

  • Site-based recruitment using site-specific recruitment text and prescreeners (site-specific PDFs listed in recruitment materials for Germany and Spain).
  • Printed materials at sites: flyers, posters, brochures (K2_Recruitment material_Flyer, Poster, Brochure documents).
  • Healthcare professional referral: Doctor Referral Letter and Doctor-to-Patient Letter (K2 recruitment documents).
  • Study brochures and participant guides (K2 recruitment brochure and Study-Guide documents).
  • Digital recruitment and marketing via Trialbee (documents: K2_Trialbee_Digital_Marketing_Content, K2_Trialbee_Overview_Supplementary_Information, Trialbee Self Assessment).
  • Study-Connect/online participant engagement materials (K2_Recruitment materials_GZPT_Study-Connect-Participant).
  • Site newsletters and site-specific questionnaires (site-specific recruitment materials and questionnaires listed for specific sites).

Geography

Total Number Of Sites
23
Total Number Of Participants
180

Germany

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
168
Number Of Sites
14
Number Of Participants
115

Sites

Site Name
Klinische Forschung Dresden
Contact Person Name
Peter Heymer
Contact Person Email
heymer@kfgn.de
Site Name
Klinische Forschung Hamburg GmbH
Contact Person Name
Marret Mehrwald
Contact Person Email
marret.mehrwald@pratia.com
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
Siteworks GmbH (Heidelberg)
Contact Person Name
Niels-Christian Hoellger
Contact Person Email
hoellger@siteworks-research.de
Site Name
Klinische Forschung Hannover-Mitte GmbH
Contact Person Name
Jan Wagner
Contact Person Email
jan.wagner@pratia.com
Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Contact Person Name
Hans-Detlev Stahl
Contact Person Email
ds@ambenet.de
Site Name
Koenig-Ludwig-Haus Orthopaedische Klinik
Department Name
Osteologie / Muskuloskelettales Zentrum
Contact Person Name
Lothar Seefried
Site Name
Siteworks GmbH (Bochum)
Contact Person Name
Annemone Koechel
Contact Person Email
koechel@siteworks-research.de
Site Name
Private Practice - Dr. Jochen Walter
Contact Person Name
Jochen Walter
Contact Person Email
j.walter@rheuma.sh
Site Name
FutureMeds GmbH
Contact Person Name
Christel Contzen
Contact Person Email
christel.contzen@globalaes.com
Site Name
Klinische Forschung Berlin-Mitte GmbH
Contact Person Name
Hartmut Tischner
Contact Person Email
hartmut.tischner@pratia.com
Site Name
CDG Studienambulanz Hartard
Contact Person Name
Manfred Hartard
Contact Person Email
m.hartard@cdg-muenchen.de
Site Name
Siteworks GmbH (Hanover - Niemeyerstrasse)
Contact Person Name
Ulrike Lengler
Contact Person Email
lengler@siteworks-research.de
Site Name
Klinische Forschung Karlsruhe GmbH
Contact Person Name
Alla Reimer
Contact Person Email
alla.reimer@pratia.com

Spain

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
11-01-2026
Processing Time Days
31
Number Of Sites
9
Number Of Participants
65

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Endocrinology and Nutrition
Contact Person Name
Andreea Ciudin
Contact Person Email
andreea.ciudin@vallhebron.cat
Site Name
Clinica Gaias Santiago
Department Name
Rheumatology
Contact Person Name
Juan Amarelo Ramos
Contact Person Email
juan.amarelo.ramos@sergas.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Endocrinology, Diabetes and Nutrition
Contact Person Name
Luis Alberto Vazquez Salvi
Contact Person Email
luisvazquezsalvi@gmail.com
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Endocrinology
Contact Person Name
Margarita Rivas Fernandez
Site Name
Hospital Quironsalud Malaga
Department Name
Endocrinology and Nutrition
Contact Person Name
Jose Manuel Garcia Almeida
Contact Person Email
jgarciaalmeida@gmail.com
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Endocrinology and Nutrition
Contact Person Name
Daniel De Luis Román
Contact Person Email
dluisro@saludcastillayleon.es
Site Name
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Department Name
Endocrinology and Nutrition
Contact Person Name
Alberto Aliaga Verdugo
Contact Person Email
aliaga.verdugo@gmail.com
Site Name
Instituto Medico Quirurgico San Rafael S.A.
Department Name
Endocrinology
Contact Person Name
Alfonso Soto Gonzalez
Contact Person Email
asotog30@outlook.es
Site Name
Poboado Nucleo Rural La Jubias 82 (site contact)
Department Name
Endocrinology
Contact Person Name
Alfonso Soto Gonzalez
Contact Person Email
asotog30@outlook.es

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD International Holdings LLC
Responsibilities
[{"id":994948,"code":"4"}]
Name
Pharmaceutical Product Development LLC
Responsibilities
[{"id":994945,"code":"4"}]
Name
Iqvia Biotech LLC
Responsibilities
[{"id":994946,"code":"1"}]

Third parties

  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"[{\"id\":994949,\"code\":\"6\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"[{\"id\":994944,\"code\":\"6\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"[{\"id\":994948,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"[{\"id\":994950,\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"[{\"id\":994947,\"code\":\"15\",\"value\":\"Imaging analysis/review\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"[{\"id\":994945,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"[{\"id\":994946,\"code\":\"1\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Orforglipron
Active Substance
ORFORGLIPRON HEMICALCIUM
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Investigational Product Name
Placebo to match LY
Modality
Other

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