Eli Lilly GZPR [PAD Trial]

Study Details

100

What is the minimum age of this Study?

18+

200

What is the minimum BMI for this study?

23

300

What is the IP for this study?

Orforglipron

400

How is this IP administered (taken)?

Orally

500

What is the primary objective of this trial?

To evaluate whether the IP is better than the placebo at increasing a patient's maximum walking distance.

Indication Information

100

What does PAD stand for?

Peripheral Arterial Disease

200

(Fill in the blank)

PAD is a condition where the arteries that carry blood to the (BLANK) becomes narrowed or blocked due to (BLANK) - also known as the buildup of fatty deposits (plaque) inside the artery. 

Limbs ; Atherosclerosis

300

( Fill in the blank)

The most common symptoms of PAD include:

#1) (BLANK) when walking that goes away with rest. 

#2) Numbness or weakness in the legs

#3) (BLANK) or color change in the lower legs or feet. 

#4) Poor wound healing on the feet or toes. 

Leg Pain ; Coldness

400

(Fill in the blank)

(BLANK) can collectively improve the circulation of blood. 

Weight Loss

500

(Fill in the blank)

This study hypothesizes that the IP can improve (BLANK) as well as (BLANK) of PAD via enhancing blood vessel health, reducing inflammation, lowering blood pressure, and improving metabolism and bodyweight. 

Walking Ability (Mobility) ; Symptoms 

Study Participation

100

How long is the treatment period? 

(In Months or Weeks)

52 Weeks (12 Months)

200

True or False...

Treadmill walking tests will take place during the screening visit.

True

300

How long is the follow up period for this trial?

2 Weeks

400

How long can the screening period take?

Up to 4 weeks. 

500

What test(s) are performed during screening to confirm the presence of PAD?

Ankle-Brachial Index (ABI) + Toe-Brachial Index (TBI)

Inclusion + Exclusion

100

Your patient is DX with PAD but does not experience any pain, cramping , or heaviness in the calf, thigh, or buttock muscles while walking or exercising. 

OK to Proceed? Or DNQ?

DNQ - This study requires PAD WITH symptomatic pain when walking but not at rest... also known as "Fontaine Stage II"

200

Your patient is taking Rifampin. 

Ok to proceed? Or DNQ?

DNQ; This is a DNQ med. 

300

Your patient is severely wheelchair bound due to a spinal chord injury over 20 years ago. They can walk around on their own but usually require assistance or a cane or walker.  

Ok to proceed? Or DNQ?

DNQ - Mobility is compromised from the spinal cord injury and not directly due to PAD. 

400

Your Pt suffers from Gastroparesis. 

Ok to proceed? Or DNQ?

DNQ. 

500

Your Pt's PAD Symptomatic Pain does not stop with rest. They experience symptoms even while resting. 

Ok to proceed? Or DNQ?

DNQ; their PAD may be too complex or severe for this study.