Could a stomach hormone help people with leg artery disease walk farther?
NCT ID NCT04377126
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether daily injections of unacylated ghrelin, a natural hormone, can improve walking ability in people aged 55 and older with peripheral artery disease (PAD). Participants receive either the hormone or a placebo for four months. The study measures changes in how far they can walk in six minutes, aiming to see if the treatment boosts blood flow and muscle function in the legs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- unacylated ghrelin
- What this could lead to
- If it works, this could point toward a new treatment to help people with PAD walk farther and maintain mobility.
- What could go wrong
- This is a small, early-phase pilot trial. The results may not confirm benefit, and the treatment may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
25 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
55 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 55 years and older 2. Presence of peripheral artery disease defined as either: 1. An ankle-brachial index (ABI) of less than or equal to 0.90 at the baseline study visit 2. Vascular lab evidence of PAD or angiographic evidence of PAD with ischemic leg symptoms during the six-minute walk and/or treadmill exercise stress test. Exclusion Criteria: 1. Above- or below-knee amputation. 2. Critical limb ischemia. 3. Wheelchair-bound or requiring a cane or walker to ambulate. 4. Walking is limited by a symptom other than PAD. 5. Current ulcer on bottom of foot. The participant may become eligible after the ulcer heals. 6. Significant liver or kidney impairment defined as two or more hepatic function enzymes \> 3.0 times the upper limit of normal and/or eGFR \< 20. \[NOTE: participants who meet this criterion may undergo a re-test of hepatic function tests to determine whether initially elevated hepatic enzymes represented a transient or spurious phenomenon.\] 7. Unwilling or unable to self-administer study drug. 8. Failure to successfully complete the study run-in. 9. Planned lower extremity revascularization or other major surgery during the next four months. 10. Lower extremity revascularization, major orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months. 11. Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who only use oxygen at night may still qualify.\] 12. Mini-Mental Status Examination (MMSE) score \< 23 13. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\] 14. Currently taking study drug(s) or has taken study drug(s) in past six months. 15. Increase in angina in last month or angina at rest. 16. Non-English speaking. 17. Visual impairment that limits walking ability. 18. Women who are pregnant or who are pre-menopausal will not be eligible. 19. Potential participants who recently participated in or are currently participating in a supervised treadmill exercise and those planning to begin a supervised treadmill exercise regimen will become eligible four months after their participation in the supervised treadmill exercise program has ended. 20. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant. 21. The potential participant does not have adequate refrigeration for storing study drug. Vulnerable populations (fetuses, pregnant women, children, prisoners, and institutionalized persons) and adults unable to consent will not be included in the study.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611-3008, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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