Liver study tests drug processing in impaired patients
NCT ID NCT06052566
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the drug efinopegdutide behaves in people with moderate to severe liver damage compared to healthy people. A total of 22 adults took a single dose, and researchers measured drug levels and safety. The goal was to understand dosing needs for patients with liver problems, not to treat the disease.
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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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22 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Dec 2024
- 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 75 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.
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * A participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention. * For participants with moderate or severe hepatic impairment: Have a diagnosis of chronic (\>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function). Exclusion Criteria: * History of cancer (malignancy). * Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit. * Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit. * Participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start. * Healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.
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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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Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida, 33147, United States
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American Research Corporation ( Site 0002)
San Antonio, Texas, 78215, United States
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Clinical Pharmacology of Miami ( Site 0005)
Miami, Florida, 33014-3616, United States
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Genesis Clinical Research, LLC ( Site 0006)
Tampa, Florida, 33603, United States
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Other studies related to the condition(s) this trial covers.
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