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Phase 1 Study of REN001 Single‑Dose Pharmacokinetics in Adults with Normal, Mild, Moderate, or Severe Liver Impairment

InvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial investigates the drug Mavodelpar, identified by the code name REN001, in people who have Impaired Hepatic Function. This condition means the liver does not work as well as normal, which can change how medicines are handled by the body.

The purpose of the study is to determine how liver problems affect the way a single 25 mg oral capsule of the medication is processed. Participants are divided into four groups based on liver health: one group with normal liver function, and three groups with mild, moderate, or severe liver impairment as measured by the Child-Pugh scoring system. Each person receives one dose and then provides blood samples over several hours while doctors check vital signs and perform safety tests.

Researchers will look at the drug’s pharmacokinetics, which is a term for how quickly the body absorbs, distributes, breaks down, and removes the medication. They will also monitor for any AEs, which are unwanted effects that might occur. Additional checks include laboratory tests, blood pressure, heart rate, and a simple heart rhythm recording to ensure participants remain safe.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening and enrollment

    After joining the study, you will undergo screening procedures to confirm eligibility. this includes a review of medical history, assessment of liver function using the child‑pugh classification, and collection of baseline laboratory tests such as blood chemistry, hematology, coagulation, and urinalysis.

    Vital signs (blood pressure, pulse, temperature, respiratory rate) and a 12‑lead electrocardiogram (ecg) will be recorded before any medication is taken.

  2. Step 2

    Baseline assessments

    The results of the screening tests are used to establish baseline values. these baseline measurements of vital signs, laboratory parameters, and the ecg will be compared with later readings to monitor safety.

  3. Step 3

    Administration of study medication

    You will receive one oral capsule containing 25 mg of mavodelpar (product name ren001). the capsule is taken with a glass of water and is the only dose given during the trial.

  4. Step 4

    Post‑dose monitoring and blood sampling

    Following the single dose, you will remain in the clinic for a monitoring period during which multiple blood samples are collected. these samples are used to evaluate the pharmacokinetics of mavodelpar, specifically measurements called auc (area under the concentration‑time curve) and cmax (maximum concentration).

    At scheduled times after the dose, vital signs and a repeat ecg will be taken to check for any immediate safety concerns.

  5. Step 5

    Follow‑up safety assessments

    Additional laboratory tests, vital sign checks, and ecg recordings are performed at later time points to continue monitoring safety and to capture any delayed effects of the medication.

    The same parameters measured at baseline (blood chemistry, hematology, coagulation, urinalysis) are re‑evaluated and compared with the baseline values.

  6. Step 6

    Study completion and discharge

    Once all required samples and assessments are completed, the study team will review the collected data. you will receive a final explanation of the study results and be discharged from the trial.

Who can join the trial?

8 criteria

  • Be a man or a woman between 18 and 70 years old.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the screening visit and again at the check‑in visit.
  • You must agree to follow the study’s birth‑control (contraception) rules to prevent pregnancy during the trial.
  • Your body‑mass index (BMI) must be between 18.0 and 40.0 at screening. (BMI is calculated by dividing your weight in kilograms by the square of your height in meters.)
  • If you have liver problems, your liver function must be classified by the Child‑Pugh score and fall into one of these groups:
    • Mild impairment (score 5‑6)
    • Moderate impairment (score 7‑9)
    • Severe impairment (score 10‑15)
    • If you are a healthy volunteer, you must have no important medical history, normal physical exam findings, normal lab test results, normal vital signs, and a normal electrocardiogram (ECG) as judged by the study doctor.

Who cannot join the trial?

7 criteria

  • People who have already taken mavodelpar, the study medication, cannot join.
  • Women who could become pregnant (childbearing potential) and are currently pregnant or breastfeeding (lactating) cannot join.
  • Anyone who works for the study site (employee or contractor) or is a close family member of the study doctor (investigator), staff, or sponsor cannot join.
  • Anyone who has received another experimental drug (investigational agent) in the last 30 days, or within five times the drug’s half‑life (the time it takes for half of the drug to leave the body), cannot join.
  • People with a health problem that the doctor thinks would stop them from completing the study tasks or would make the study results unclear (called “confounding”) cannot join.
  • Anyone with a history of heart problems (cardiac disease) or important heart test (ECG) abnormalities cannot join.
  • People whose heart beat (pulse rate) is slower than 40 beats per minute or faster than 99 beats per minute during the screening visit cannot join.
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Investigated drugs

REN001 is an experimental oral capsule that is being studied for the first time in humans. In this trial, participants take a single dose of the capsule to see how the drug moves through the body when the liver is not working normally. The purpose is to understand how liver problems might change the way the medication is absorbed, distributed, broken down, and cleared, which helps researchers determine safe and effective use in people with liver impairment.

What is already known about the treatment

REN001 - REN001 is taken as an oral capsule that contains 25 mg of a sodium‑based compound. It is still an experimental medicine and has not been approved for general use, appearing only in early research studies. The drug is being examined for possible use in people with liver problems, although its exact therapeutic purpose is still being defined. It works by attaching to a specific protein that influences cell signaling, classifying it as a small‑molecule modulator.

Investigated diseases

  • Mild hepatic impairment

    This condition refers to a slight reduction in the liver’s ability to carry out its normal metabolic and synthetic roles. People may notice subtle fatigue or mild changes in routine blood tests. The liver can often compensate for the loss, but ongoing injury or disease can cause the impairment to progress. If the underlying cause is not addressed, the condition may advance to a more severe stage.

  • Moderate hepatic impairment

    In this stage the liver’s function is noticeably decreased, leading to more evident symptoms such as tiredness, mild jaundice, or swelling in the abdomen. The organ’s capacity to process nutrients, drugs, and toxins is reduced, affecting overall health. Without improvement in the underlying condition, the impairment can continue to decline. Continued damage may eventually result in severe loss of liver function.

  • Severe hepatic impairment

    This represents a marked loss of liver function, where the organ can no longer adequately perform its essential metabolic, synthetic, and detoxifying tasks. Individuals may experience pronounced fatigue, significant jaundice, fluid accumulation, and a higher tendency for bleeding. The condition is often stable but can worsen if the causative disease progresses. Further decline can lead to critical loss of liver capacity.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504007-91-00Protocol codeREN001-108Estimated enrolment32 patientsSponsorReneo Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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