Clinical trial • Phase III • Cardiology

ORFORGLIPRON HEMICALCIUM for Peripheral Arterial Disease

Phase III trial of ORFORGLIPRON HEMICALCIUM for Peripheral Arterial Disease.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Peripheral Arterial Disease
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-10-2025
First CTIS Authorization Date
17-02-2026

Trial design

Randomised, orforglipron — once daily (dose not specified); placebo to match orforglipron (placebo arm)-controlled Phase III trial in Netherlands, Slovakia, Poland and others.

Randomised
Yes
Comparator
Orforglipron — once daily (dose not specified); Placebo to match orforglipron (placebo arm)
Target Sample Size
1065
Trial Duration For Participant
364

Eligibility

Recruits 1065 No vulnerable population selected. Informed consent materials and eConsent/eSignature documents are provided (subject information and ICF, eConsent screenshots, eSignature In-Person Consent Quick Reference Guide, country-specific SIS/ICF documents)..

Vulnerable Population
No vulnerable population selected. Informed consent materials and eConsent/eSignature documents are provided (subject information and ICF, eConsent screenshots, eSignature In-Person Consent Quick Reference Guide, country-specific SIS/ICF documents).

Inclusion criteria

  • {"criterion_text":"- Have symptoms of Peripheral Artery Disease (PAD), causing pain when you walk"}

Exclusion criteria

  • {"criterion_text":"- Have a BMI less than 23 kg/m2"}
  • {"criterion_text":"- Have HbA1c greater than 10%"}
  • {"criterion_text":"- Have had or plan to have a leg surgery to improve blood flow in your legs"}
  • {"criterion_text":"- Have had a heart condition within 60 days prior to screening"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent Change from Baseline in Maximum Walking Distance On a constant load treadmill test [Time Frame: Baseline, Week 52]","definition_or_measurement_approach":"Percent change from baseline in maximum walking distance measured using a constant-load treadmill test at Baseline and Week 52."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
1065
Recruitment Window Months
24
Consent Approach
Informed consent via a Main ICF (subject information sheet and ICF). eConsent and eSignature options available (eConsent participant-facing screenshots, eSignature In-Person Consent Quick Reference Guide). Country/language-specific ICF and SIS documents available (translations and country-specific ICFs: e.g. PL, FR, NL, SK). Participants provide consent; no vulnerable populations selected (no assent procedures specified).

Methods

  • Digital advertising and social media (digital ad copy, visuals, social media video script) targeting patients with PAD; country-specific digital materials available (e.g. Poland, France).
  • Flyers, posters and brochures (printed recruitment materials) distributed at sites.
  • Doctor referral letters and doctor-to-patient letters to facilitate clinician referrals.
  • Call center support and digital recruitment campaign (third-party vendor involvement).
  • Database and patient messaging, patient invitation emails and survey invitations (LITES study platform and survey invitations).

Geography

Total Number Of Sites
17
Total Number Of Participants
185

Netherlands

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
12
Number Of Sites
3
Number Of Participants
50

Sites

Site Name
Radboud UMC
Department Name
Vascular Surgery
Contact Person Name
Michiel Warlé
Contact Person Email
michiel.warle@radboudumc.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Interne Geneeskunde
Contact Person Name
Simone Hartong
Contact Person Email
s.c.c.hartong@asz.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Vascular Surgery
Contact Person Name
Marc R.H.M. Sambeek

Slovakia

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
11
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
Medivasa s.r.o.
Contact Person Name
Viliam Bugan
Contact Person Email
bugan@medivasa.sk
Site Name
Alian s.r.o.
Contact Person Name
Andrej Dzupina
Contact Person Email
dzupina@alian.sk

Poland

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
16
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Centrum Medyczne Komorniki Sp. z o.o.
Department Name
Poradnia Kardiologiczna
Contact Person Name
Marta Karczewska-Mastalerz
Site Name
Centrum Medyczne Intercor Sp. z o.o.
Department Name
Badania Kliniczne
Contact Person Name
Grzegorz Grześk
Contact Person Email
grzegorz.grzesk@interia.pl
Site Name
Serce Sp. z o.o.
Department Name
Poradnia Specjalistyczna
Contact Person Name
Witold Piotrowski
Contact Person Email
witold.piotrowski@farmepo.com
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
Department Name
Poradnia Kardiologiczna
Contact Person Name
Waldemar Bieniek
Contact Person Email
waldemar.bieniek01@gmail.com
Site Name
Przychodnie Grudziadz Sp. z o.o.
Contact Person Name
Piotr Kubalski
Contact Person Email
piotr.kubalski@farmepo.com

France

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
68
Number Of Sites
7
Number Of Participants
60

Sites

Site Name
Centre Hospitalier Universitaire d'Angers
Department Name
Médecine Vasculaire
Contact Person Name
Pierre ABRAHAM
Contact Person Email
piabraham@chu-angers.fr
Site Name
Groupe hospitalier Paris saint Joseph
Department Name
Services de Chirurgie Vasculaire
Contact Person Name
Yann GOUEFFIC
Contact Person Email
ygoueffic@ghpsj.fr
Site Name
Hôpital Saint Philibert
Department Name
Chirurgie et medecine vasculaire
Contact Person Name
Marjolaine TALBOT
Contact Person Email
talbot.marjolaine@ghicl.net
Site Name
Centre Hospitalier Universitaire de Rennes , Hôpital Pontchaillou
Department Name
Centre d'Investigation Clinique CIC1414
Contact Person Name
Guillaume MAHE
Contact Person Email
guillaume.mahe@chu-rennes.fr
Site Name
Hôpital Européen Georges Pompidou
Department Name
Service de médecine vasculaire ,7e Pôle C
Contact Person Name
Tristan MIRAULT
Contact Person Email
tristan.mirault@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Chirurgie et Médecine Vasculaire
Contact Person Name
Georges LEFTHERIOTIS
Contact Person Email
leftheriotis.g@chu-nice.fr
Site Name
CHRU Troussau
Department Name
Cardiologie
Contact Person Name
Jean-Baptiste DE FREMINVILLE

Sponsor

Primary sponsor

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

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
sponsorDuties code: 11
Name
IQVIA Limited
Responsibilities
sponsorDuties code: 4
Name
Icon Public Limited Company
Responsibilities
sponsorDuties code: 8
Name
Iqvia Inc.
Responsibilities
sponsorDuties code: 1

Third parties

  • {"country":"United Kingdom","full_name":"Inventus Group Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 11","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Lionbridge Technologies Inc","duties_or_roles":"Translation of R&R materials","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Site Training. Content Development.","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Zoom","duties_or_roles":"Other","organisation_type":"Health care"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Shipping of Recruitment and Retention, Appreciation Items, and CSSRS","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Colorado Prevention Center","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"sponsorDuties code: 13","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Digital Recruitment Campaign and Call Center","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Linguistically Validated Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Florence","duties_or_roles":"N/A","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Orforglipron
Active Substance
ORFORGLIPRON HEMICALCIUM
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Not authorised (investigational)
Frequency
Once daily
Investigational Product Name
Placebo to match ly
Modality
Other

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