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Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Recruiting Phase 3 Interventional Study
Peripheral Arterial Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,205 (estimated)
Sponsor
Eli Lilly and Company · Industry
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About This Trial

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.

Trial Locations

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Eligibility Criteria
Inclusion Criteria: * Have symptomatic PAD with intermittent claudication of Fontaine Stage II * Have an Ankle Brachial Index (ABI) of 0.9 or less Exclusion Criteria: * Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2) * Have Hemoglobin A1c (HbA1c) greater than 10% * Hav…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT

NCT ID: NCT07223593 Source: ClinicalTrials.gov