Kidney patients needed to test how drug moves in body
NCT ID NCT07426380
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times
Summary
This study looks at how the drug eloralintide enters the bloodstream and leaves the body in people with severe kidney disease or kidney failure, compared to healthy volunteers. About 28 participants will receive a single shot under the skin. The study lasts about 14 weeks and does not aim to treat any condition.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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: * Have a body weight of 55 kilograms (kg) or more and a body mass index (BMI) within the range of 19.0 to 40.0 kilograms per square meter (kg/m²), inclusive * Have no significant history of spontaneous or ethanol-induced hypoglycemia Additional Inclusion Criteria for Group 1 * Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliters per minute (mL/min) * Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening Additional Inclusion Criteria for Groups 2 and 3 * Have stable severe renal impairment, assessed by eGFR less than 30 mL/min at screening or with end-stage renal disease (ESRD) who have been on a stable hemodialysis (HD) schedule for at least 3 months prior to planned dosing * Have acceptable blood pressure and pulse rate * If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 10.0% at screening Exclusion Criteria: * Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments * Have a current, functioning organ transplant. Nonfunctional renal allografts may be considered * Have significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational product; or interfering with the interpretation of data Groups 2 and 3 * Are receiving continuous HD or peritoneal dialysis. * Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before eloralintide administration
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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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Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016-1518, United States
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Omega Research Orlando LLC
Orlando, Florida, 32808, United States
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Other studies related to the condition(s) this trial covers.
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