Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

Conditions

• Peripheral Arterial Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Orforglipron — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Oct 31, 2025

Status verified

Jun 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

1,205 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Orforglipron
  Participants will receive orforglipron orally
• Placebo Comparator: Placebo
  Participants will receive placebo orally

Primary Outcome Measure

Percent Change from Baseline in Maximum Walking Distance [ Time Frame: Baseline, Week 52 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (30)

Find similar trials in Birmingham, AL

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