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RecruitingPhase 1

A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide

A Phase 1, Open Label, Parallel Group Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics of Ribupatide in Healthy Participants and in Participants Living With Severe Renal Impairment or End Stage Kidney Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The primary objective of the study is to estimate the PK parameters of ribupatide in participants with severe renal impairment or end-stage kidney disease (ESKD) after a single dose of ribupatide subcutaneous (SC) injection compared with participants with normal renal function."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the body handles ribupatide after one shot under the skin. It compares people who have severe kidney problems or end-stage kidney disease (kidney failure) with people whose kidneys work normally.

The primary objective of the study is to estimate the PK parameters of ribupatide in participants with severe renal impairment or end-stage kidney disease (ESKD) after a single dose of ribupatide subcutaneous (SC) injection compared with participants with normal renal function.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure of weight compared with height, of at least 18.5 at screening.
  • Female participants must not be pregnant, breastfeed, or plan either during the study or for at least 35 days after the dose.
  • Female participants must have a negative blood pregnancy test at screening.
  • Have veins that can be used for blood tests.

Who can't join

  • Have a history of serious disease or a recent illness within the past 3 months that the study doctor considers important. This includes heart, lung, liver, kidney, blood, digestive, hormone, immune, skin, mental health, or nervous system problems.
  • Have an abnormal thyroid-stimulating hormone level at screening. This hormone helps control the thyroid gland.
  • Have had cancer within the past 5 years, including early cervical or prostate cancer.
  • Have a history of or a positive screening test for HIV or hepatitis B surface antigen (a sign of hepatitis B), or have an active hepatitis C infection.
  • Took part in another study of an experimental drug or device too recently: within 30 days before screening, or longer if needed for 5 drug half-lives to pass. A half-life is the time it takes the body to remove half of a drug.
  • Used semaglutide, tirzepatide, or medicines that activate GLP-1, GLP-1/GIP, or glucagon receptors within 3 months before screening. These medicines act on hormone signals.
  • Have a known allergy to ribupatide, its ingredients, or GLP-1 medicines.
  • Had a vaccine within 30 days before screening, or have a current infection needing medicine that works throughout the body within 10 days before the study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Body mass index ≥18.5 at Screening. * Female Participants: Must not be pregnant or planning to be pregnant or breastfeeding or planning to breastfeed during the study and for at least 35 days after the study drug dose. * Female participants: Must have a negative serum pregnancy test at Screening. * Suitable venous access for blood sampling. Exclusion Criteria: * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the Investigator (or delegate) to be clinically relevant. * Abnormal thyroid-stimulating hormone at Screening. * Any history of malignant disease including in situ cervical or prostate cancer within the last 5 years. * History of or positive test results at the Screening Visit for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or active hepatitis C virus (HCV) infection. * Participated in another clinical study of a study drug or investigational device within 30 days or 5 half-lives of the study drug (whichever is longer) prior to Screening. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist, or glucagon receptor agonist within 3 months prior to Screening. * Known hypersensitivity to the study drug, glucagon-like peptide-1 (GLP-1) therapies, or any of the study drug ingredients. * Received any vaccinations within 30 days prior to Screening. * Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medication within 10 days prior to the dose of study drug.

Study sites (2)

FL

TX