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Kidney-Liver drug trial halted early – what happened?

NCT ID NCT06939816

Disease control Sponsor: Enyo Pharma Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 small Phase 2 study tested two doses of vonafexor, an oral drug, in 10 people with mild-to-moderate chronic kidney disease and suspected MASH (a type of fatty liver disease). The goal was to see if vonafexor could improve kidney function. However, the trial was terminated early, so the results are limited and we cannot draw firm conclusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vonafexor (oral tablets)
What this could lead to
If it had worked, vonafexor might have pointed toward a new way to protect kidney function in people with both kidney disease and fatty liver disease.
What could go wrong
The trial was terminated early with only 10 participants, so we have very little data. It is too early to know if vonafexor is safe or effective for this 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Jul 2025

Finished

Mar 2026

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Signed and dated informed consent obtained before any trial-related activities * Male or female subject. * Age between 18 and 75 years, both inclusive. * Overweight or obesity (body mass index BMI ≥ 25.0 kg/m2 and ≤ 45.0 kg/m2) with or without type 2 diabetes mellitus (T2DM with an HbA1c ≤ 9.5%). * eGFR ≥ 30 and \< 90 (mL/min/1.73 m²). * Presumed mild to higher liver fibrosis as shown by a FIBROTEST score ≥ 0.28 and/or FIB-4 score ≥ 1.3. Exclusion Criteria: * Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation. * Previous participation in this trial. Participation is defined as randomised. * Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial. * History of multiple and/or severe allergies to drugs including contrast media or foods or a history of severe anaphylactic reaction. * Known non-MASH liver disease. * History or presence of cirrhosis (evidenced on imaging or by histology, or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices). * Total body weight loss of \>5% within 6 months prior to screening. * If female, pregnancy or breast-feeding. * Women of childbearing potential who are not using a highly effective contraceptive method and whose male partner is not using a highly effective contraceptive method for the entire study duration and for at least 6 weeks after last dosing

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease stage 2 Chronic kidney disease stage 3 Metabolic dysfunction-associated steatohepatitis

Contacts and locations

Locations

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460, Germany

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