NASHPhase 2CODINNCT06588699
Digoxin In NASH (CODIN)
A Phase 2 study testing Digoxin in people with NASH and NAFLD, run by Yale University at 2 sites in United States.
Trial summary
Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH, NAFLD, MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2025to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening
- Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening
- Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening
- Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization Exclusion Criteria
- Liver-related:
- Documented causes of chronic liver disease other than NASH
Show all 38Show fewer
- History or clinical evidence of cirrhosis or portal hypertension
- History of positive HBsAg, positive anti-HIV, positive HCV-RNA
- AST or ALT > 5 times upper limit of normal (ULN) at screening
- Total bilirubin > 1.5 mg/dL at screening unless conjugated bilirubin is < 1.5 × ULN
- International normalized ratio (INR) > 1.3 at screening
- Known or suspected alcohol use > 20 g/day for women or > 30 g/day for men
- Treatment initiation or dose adjustment of vitamin E, pioglitazone, GLP-1RA, or SGLT-2 inhibitors within 30 days of signing the informed consent or 30 days prior to liver biopsy
- Treatment initiation or anticipated treatment (>14 consecutive days) with medications known to affect steatosis (e.g., systemic corticosteroids, tamoxifen, valproic acid, methotrexate, tetracycline or amiodarone) within 30 days of signing the informed consent or 30 days prior to liver biopsy
- Cardiac related:
- Heart rate less than 60 bpm at screening (visit 1) or at baseline (visit 2)
- Current diagnosis of severe aortic valve disease
- History of Accessory arterio-ventricular pathway (e.g., Wolf-Parkinson-White syndrome)
- History of complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device
- Current diagnosis of permanent atrial fibrillation
- Any of the following within the previous 6 months of signing informed consent: myocardial infarction, percutaneous intervention, pacemaker/implantable cardiac device implantation, cardiac surgery, or stroke
- Current use of the following medications: inotropic drugs such as (dopamine, dobutamine, noradrenaline, milrinone), anti-arrhythmics (amiodarone, dofetilide, sotalol, dronedarone, digoxin), parathyroid hormone analog (teriparatide), sympathomimetics (epinephrine, norepinephrine, dopamine), neuromuscular blocking agents (succinylcholine), calcium supplement, nondihydropyridine calcium channel blockers, ivabradine, and disulfiram.
- Obesity related:
- Treatment initiation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) with orlistat, zonisamide, topiramate, phentermine, bupropion, and naltrexone alone or in combination or any other medication that could promote weight loss in the opinion of the investigator
- Participation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) in an organized diet-based weight reduction program (e.g., WeightWatchers, Optifast)
- Recent surgical treatment (<6 months of signing informed consent) for obesity
- General safety related:
- Presence or history of malignant neoplasms (in the past 5 years prior to screening), except basal and squamous cell skin cancer and any carcinoma in-situ
- Surgery scheduled or anticipated during the trial period, except for minor surgical procedures, in the opinion of the investigator
- Language barrier, mental incapacity, unwillingness, or inability to adequately understand or comply with study procedures
- Known or suspected hypersensitivity to the trial product or related products including allergy to milk, egg, soy, peanuts, and sulfites
- Recent participation (within 90 days prior to signing the informed consent) in any clinical trial of an approved or non-approved investigational medicinal product
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR < 30 ml/min/1.73 m2
- TSH > 6 mIU/L or < 0.4 mIU/L at screening
- Current use of the following medications: calcium supplementation, parathyroid hormone analog (teriparatide), neuromuscular blocking agents (succinylcholine) and disulfiram.
- Claustrophobia to an extent that would prevent tolerance of MRI
- Metallic implant that would prevent MRI examination including, metallic foreign body, aneurysm clips, vascular grafts or cardiac implants, neural stimulator, cochlear implant, metallic contraceptive device, body piercing that cannot be removed, cochlear implant, or any other contraindication to MRI
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tara McPartland contact
United States2 sites, 2 recruiting
- Recruiting
Yale New Haven Health
New Haven, Connecticut, 06510
Bubu Banini, MD, bubu.banini@yale.edu
Aida Rodriguez Murillo, aida.rodriguezmurillo@yale.edu
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Bubu Banini, MD, bubu.banini@yale.edu
Aida Rodriguez Murillo, aida.rodriguezmurillo@yale.edu
About this study
Official title: Clinical Trial of Oral Digoxin In NASH (CODIN)
Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.
Read the detailed description
Prospective, randomized, double-blind, placebo-controlled, single center trial of digoxin in patients with nonalcoholic steatohepatitis (NASH).
Primary objective:
To compare the effect of digoxin oral, administered once daily (QD) either as titration-based or weight-based dose, versus placebo on histologic resolution of NASH
Key secondary objectives:
To investigate the effect of digoxin oral, administered once daily (QD) either as titration-based or weight-based dose, compared to placebo on histologic, imaging, and biochemical markers of NASH, and to assess the safety and tolerability of digoxin compared to placebo
- Conditions
- NASH, NAFLD, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Mash, MASH With Fibrosis, MASLD
- Being tested
- Digoxin, Placebo
- Keywords
- NASH, MASH, Metabolic dysfunction associated steatohepatitis, Digoxin, Drug repurposing, Liver fibrosis, Fatty liver disease, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigoxinDrug
Taken orally once daily
PlaceboDrug
Matched Placebo taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Digoxin (titration-based) | Experimental | Digoxin (titration-based) taken orally once daily. In this arm, the intervention will be administered dosed by weight and renal function using a well-studied digoxin nomogram. Receives: Drug: Digoxin |
| Digoxin (weight-based) | Experimental | Digoxin (weight-based) taken orally once daily. In the weight-based digoxin arm, the intervention will be oral digoxin 0.15mcg/kg/day. Receives: Drug: Digoxin |
| Placebo | Placebo comparator | Placebo, taken orally once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of nonalcoholic steatohepatitis (NASH) without worsening of fibrosis
Proportion of participants who achieve resolution of NASH (defined by the NASH Clinical research network [CRN] as a score of 0-1 for inflammation, 0 for hepatocyte ballooning, and any value for steatosis) with no worsening of fibrosis (yes/no).
Measured: 24 weeks
Secondary outcomes (9)
Improvement in liver fibrosis without worsening of NASH
Proportion of participants with improvement in liver fibrosis by ≥ 1 stage with no worsening of NASH (yes/no). Worsening of NASH is defined as ≥ 1 increase in lobular inflammation or hepatocyte ballooning according to criteria by the NASH clinical research network (NASH CRN)
Measured: 24 weeks
Improvement in NAS without worsening of fibrosis
Proportion of participants with improvement in nonalcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 2 with no worsening of fibrosis after 24 weeks (yes/no)
Measured: 24 weeks
Change in enhanced liver fibrosis (ELF) score
Change in Enhanced Liver Fibrosis (ELF) score.
Measured: 24 weeks
Change in alanine aminotransferase (ALT)
Change in serum alanine aminotransferase (ALT) concentration (pg/ml)
Measured: 24 weeks
Change in aspartate aminotransferase (AST)
Change in serum aspartate aminotransferase (AST) concentration (pg/ml)
Measured: 24 weeks
Change in gamma glutamyl transferase (GGT)
Change in serum gamma glutamyl transferase (GGT) concentration (pg/ml)
Measured: 24 weeks
Change in liver stiffness measure (LSM) and controlled attenuation parameter (CAP)
Change in liver stiffness measure (LSM) and controlled attenuation parameter (CAP) from baseline as measured by transient elastography.
Measured: 24 weeks
Change in magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Change in magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured: 24 weeks
Change in Magnetic resonance elastography (MRE)
Change from baseline in magnetic resonance elastography (MRE)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Jun 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NASHStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Model description
- A centrally administered randomization strategy will be used to randomize patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bubu Banini, MD, PhD, Yale University
- Investigators
- Bubu A Banini, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588699
- Sponsor's protocol ID
- 2000038275
- Other IDs
- 1R01DK134624-01A1
- Acronym
- CODIN
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2024
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
Publications
Jamshed F, Dashti F, Ouyang X, Mehal WZ, Banini BA. New uses for an old remedy: Digoxin as a potential treatment for steatohepatitis and other disorders. World J Gastroenterol. 2023 Mar 28;29(12):1824-1837. doi: 10.3748/wjg.v29.i12.1824.
PubMed 37032732Dashti F, Jamshed F, Ouyang X, Mehal WZ, Banini BA. Digoxin as an emerging therapy in noncardiac diseases. Trends Pharmacol Sci. 2023 Apr;44(4):199-203. doi: 10.1016/j.tips.2022.10.002. Epub 2022 Nov 14.
PubMed 36396496Agyapong G, Dashti F, Banini BA. Nonalcoholic liver disease: Epidemiology, risk factors, natural history, and management strategies. Ann N Y Acad Sci. 2023 Aug;1526(1):16-29. doi: 10.1111/nyas.15012. Epub 2023 Jul 3.
PubMed 37400359Ilagan-Ying YC, Banini BA, Do A, Lam R, Lim JK. Screening, Diagnosis, and Staging of Non-Alcoholic Fatty Liver Disease (NAFLD): Application of Society Guidelines to Clinical Practice. Curr Gastroenterol Rep. 2023 Oct;25(10):213-224. doi: 10.1007/s11894-023-00883-8. Epub 2023 Sep 28.
PubMed 37768417
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Oral Digoxin In NASH (CODIN)
- ClinicalTrials.gov ID
- NCT06588699
- Acronym / sponsor ID
- CODIN / 2000038275
- Conditions
- NASH, NAFLD, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Mash, MASH With Fibrosis, MASLD
- Keywords
- NASH, MASH, Metabolic dysfunction associated steatohepatitis, Digoxin, Drug repurposing, Liver fibrosis, Fatty liver disease, NAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 19 Sep 2024 (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.
Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.
Detailed description
Prospective, randomized, double-blind, placebo-controlled, single center trial of digoxin in patients with nonalcoholic steatohepatitis (NASH).
Primary objective:
To compare the effect of digoxin oral, administered once daily (QD) either as titration-based or weight-based dose, versus placebo on histologic resolution of NASH
Key secondary objectives:
To investigate the effect of digoxin oral, administered once daily (QD) either as titration-based or weight-based dose, compared to placebo on histologic, imaging, and biochemical markers of NASH, and to assess the safety and tolerability of digoxin compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A centrally administered randomization strategy will be used to randomize patients.
| Arm | Type | Receives |
|---|---|---|
| Digoxin (titration-based) | Experimental | Drug: DigoxinDigoxin (titration-based) taken orally once daily. In this arm, the intervention will be administered dosed by weight and renal function using a well-studied digoxin nomogram. |
| Digoxin (weight-based) | Experimental | Drug: DigoxinDigoxin (weight-based) taken orally once daily. In the weight-based digoxin arm, the intervention will be oral digoxin 0.15mcg/kg/day. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, taken orally once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening
- Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening
- Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening
- Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization Exclusion Criteria
- Documented causes of chronic liver disease other than NASH
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DigoxinTaken orally once daily | Drug | Digoxin (titration-based), Digoxin (weight-based) |
| PlaceboMatched Placebo taken orally once daily | Drug | Placebo |
Primary outcome
Resolution of nonalcoholic steatohepatitis (NASH) without worsening of fibrosis
Time frame: 24 weeks
Proportion of participants who achieve resolution of NASH (defined by the NASH Clinical research network [CRN] as a score of 0-1 for inflammation, 0 for hepatocyte ballooning, and any value for steatosis) with no worsening of fibrosis (yes/no).
9 secondary outcomes
Improvement in liver fibrosis without worsening of NASH
Time frame: 24 weeks
Improvement in NAS without worsening of fibrosis
Time frame: 24 weeks
Change in enhanced liver fibrosis (ELF) score
Time frame: 24 weeks
Change in alanine aminotransferase (ALT)
Time frame: 24 weeks
Change in aspartate aminotransferase (AST)
Time frame: 24 weeks
Change in gamma glutamyl transferase (GGT)
Time frame: 24 weeks
Change in liver stiffness measure (LSM) and controlled attenuation parameter (CAP)
Time frame: 24 weeks
Change in magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame: 24 weeks
Change in Magnetic resonance elastography (MRE)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 37032732Jamshed F, Dashti F, Ouyang X, Mehal WZ, Banini BA. New uses for an old remedy: Digoxin as a potential treatment for steatohepatitis and other disorders. World J Gastroenterol. 2023 Mar 28;29(12):1824-1837. doi: 10.3748/wjg.v29.i12.1824.
- Background: PubMed 36396496Dashti F, Jamshed F, Ouyang X, Mehal WZ, Banini BA. Digoxin as an emerging therapy in noncardiac diseases. Trends Pharmacol Sci. 2023 Apr;44(4):199-203. doi: 10.1016/j.tips.2022.10.002. Epub 2022 Nov 14.
- Background: PubMed 37400359Agyapong G, Dashti F, Banini BA. Nonalcoholic liver disease: Epidemiology, risk factors, natural history, and management strategies. Ann N Y Acad Sci. 2023 Aug;1526(1):16-29. doi: 10.1111/nyas.15012. Epub 2023 Jul 3.
- Background: PubMed 37768417Ilagan-Ying YC, Banini BA, Do A, Lam R, Lim JK. Screening, Diagnosis, and Staging of Non-Alcoholic Fatty Liver Disease (NAFLD): Application of Society Guidelines to Clinical Practice. Curr Gastroenterol Rep. 2023 Oct;25(10):213-224. doi: 10.1007/s11894-023-00883-8. Epub 2023 Sep 28.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
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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.
Tara McPartland contact
Bubu A Banini, MD, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Digoxin in people with NASH and NAFLD, run by Yale University at 2 sites in United States.
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 38 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bubu Banini, MD, PhD (203-737-6063 or 203-215-7749, bubu.banini@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of nonalcoholic steatohepatitis (NASH) without worsening of fibrosis (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588699, which also lists 4 linked publications.
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 26 May 2026.