Chronic Kidney Disease Stage 2Phase 2MASHNCT06939816
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
A Phase 2 study testing Vonafexor low dose and Vonafexor high dose in people with Chronic Kidney Disease Stage 2 and Chronic Kidney Disease Stage 3, run by Enyo Pharma at 1 site in Germany.
Trial summary
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3, Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- Vonafexor low dose and Vonafexor high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2025to 13 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.
Read the detailed description
This is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks:
- Screening: 4 weeks
- Treatment: 16 weeks
- Follow-up: 12 weeks
- Conditions
- Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3, Metabolic Dysfunction-Associated Steatohepatitis
- Being tested
- Vonafexor low dose, Vonafexor high dose
- Keywords
- CKD, Chronic Kidney Disease, MASH, Metabolic Dysfunction-Associated Steatohepatitis, Kidney function, eGFR, estimated Glomerular function rate, mGFR, measured Glomerular function rate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonafexor low doseDrug
Oral tablets
Vonafexor high doseDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Vonafexor low dose | Experimental | Vonafexor low dose 1 tablet per day Receives: Drug: Vonafexor low dose |
| Vonafexor high dose | Experimental | Vonafexor high dose 1 tablet per day Receives: Drug: Vonafexor high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of mGFRiohexol at week 16
Measured: 16 weeks
Change from baseline of eGFRcreatinine at week 16
Measured: 16 weeks
Secondary outcomes (6)
Vonafexor plasma concentrations
Plasma concentrations pre-dose and post-dose which will be modelled against the MASH PopPK expected values
Measured: 16 weeks
Change from baseline mGFRiohexol off treatment at week 24
Measured: 24 weeks
Change from baseline of eGFRcreatinine on treatment at weeks 4, 8, 12 and off treatment at weeks 20, 24 and 28
Measured: 28 weeks
Correlation of mGFRiohexol with eGFRcreatinine at baseline, on treatment at week 16 and off treatment at week 24
Measured: 24 weeks
Levels and change in proteinuria in morning urine samples at baseline, on treatment at weeks 4, 8, 12, 16 with off treatment at weeks 20, 24 and 28
Measured: 28 weeks
Treatment-emergent adverse events and serious adverse events
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jul 2025
- Primary completion22 Dec 2025
- Study completion13 Mar 2026
Why it stopped: Pilot cohort (n=10) yielded useful insights but data remains exploratory due to limited sample size. Study stopped due to strategic reprioritization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enyo Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939816
- Sponsor's protocol ID
- EYP001-210
- Other IDs
- 2023-509192-16-00, 2023
- Acronym
- MASH
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline published results might be shared upon request with researchers who provide a methodologically sound proposal and to achieve objectives as set in the approved proposal. IPD will be shared deidentified and from 3 months and ending 5 years following article publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH
- ClinicalTrials.gov ID
- NCT06939816
- Acronym / sponsor ID
- MASH / EYP001-210
- Conditions
- Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3, Metabolic Dysfunction-Associated Steatohepatitis
- Keywords
- CKD, Chronic Kidney Disease, MASH, Metabolic Dysfunction-Associated Steatohepatitis, Kidney function, eGFR, estimated Glomerular function rate, mGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pilot cohort (n=10) yielded useful insights but data remains exploratory due to limited sample size. Study stopped due to strategic reprioritization.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Enyo PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.
Detailed description
This is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks:
- Screening: 4 weeks
- Treatment: 16 weeks
- Follow-up: 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonafexor low dose | Experimental | Drug: Vonafexor low doseVonafexor low dose 1 tablet per day |
| Vonafexor high dose | Experimental | Drug: Vonafexor high doseVonafexor high dose 1 tablet per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vonafexor low doseOral tablets | Drug | Vonafexor low dose |
| Vonafexor high doseOral tablets | Drug | Vonafexor high dose |
Primary outcome
Change from baseline of mGFRiohexol at week 16
Time frame: 16 weeks
Change from baseline of eGFRcreatinine at week 16
Time frame: 16 weeks
6 secondary outcomes
Vonafexor plasma concentrations
Time frame: 16 weeks
Change from baseline mGFRiohexol off treatment at week 24
Time frame: 24 weeks
Change from baseline of eGFRcreatinine on treatment at weeks 4, 8, 12 and off treatment at weeks 20, 24 and 28
Time frame: 28 weeks
Correlation of mGFRiohexol with eGFRcreatinine at baseline, on treatment at week 16 and off treatment at week 24
Time frame: 24 weeks
Levels and change in proteinuria in morning urine samples at baseline, on treatment at weeks 4, 8, 12, 16 with off treatment at weeks 20, 24 and 28
Time frame: 28 weeks
Treatment-emergent adverse events and serious adverse events
Time frame: 28 weeks
Results and safety
The study was stopped early (reason given: Pilot cohort (n=10) yielded useful insights but data remains exploratory due to limited sample size. Study stopped due to strategic reprioritization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underline published results might be shared upon request with researchers who provide a methodologically sound proposal and to achieve objectives as set in the approved proposal. IPD will be shared deidentified and from 3 months and ending 5 years following article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vonafexor low dose and Vonafexor high dose in people with Chronic Kidney Disease Stage 2 and Chronic Kidney Disease Stage 3, run by Enyo Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Pilot cohort (n=10) yielded useful insights but data remains exploratory due to limited sample size. Study stopped due to strategic reprioritization.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of mGFRiohexol at week 16 (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.