Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a stomach hormone help people with leg artery disease walk farther?

NCT ID NCT04377126

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jul 2020

Finished

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Peripheral artery disease are added.

Vår säkerhetsrekommendation!

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

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611-3008, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.