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NCT03432260: AH

A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

Completed Phase 2 Results posted Last updated 24 September 2024
What this trial tests

Phase 2 trial testing DUR-928 30 mg in Alcoholic Hepatitis in 19 participants. Completed in 9 September 2019.

Timeline
18 April 2018
Primary endpoint
9 September 2019
9 September 2019

Quick facts

Lead sponsorDurect
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment19
Start date18 April 2018
Primary completion9 September 2019
Estimated completion9 September 2019
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Durect — full company profile →

Who can join

21 and older, any sex, with Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lille Model for Alcoholic Hepatitis Score Primary · Day 7

The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score \>0.45 predicts a higher risk of death and the recommendation to stop steroid administration. Lille Score = Exp(-R)/(1 + Exp(-R)) Where: R = \[3.19 - (0.101 x Age in years)\] + (1.47 x Albumin in g/dL) + \[0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)\] - (0.206 x Creatinine in mg/dL) - (0.

GroupValue95% CI
Moderate AH DUR-928 30 mg0.0200.01 – 0.04
Moderate AH DUR-928 90 mg0.0500.01 – 0.05
Severe AH DUR-928 30 mg0.1550.05 – 0.19
Severe AH DUR-928 90 mg0.1950.04 – 0.24
Severe AH DUR-928 150 mg0.4200.08 – 0.87
Model for End Stage Liver Disease (MELD) Score Primary · Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28

The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin

Screening
GroupValue95% CI
Moderate AH DUR-928 30 mg19.515 – 20
Moderate AH DUR-928 90 mg19.014 – 21
Severe AH DUR-928 30 mg24.521 – 28
Severe AH DUR-928 90 mg24.521 – 28
Severe AH DUR-928 150 mg25.023 – 27
Day 1 Pre-dose
GroupValue95% CI
Moderate AH DUR-928 90 mg20.020 – 20
Severe AH DUR-928 30 mg23.021 – 26
Severe AH DUR-928 90 mg24.024 – 24
Severe AH DUR-928 150 mg23.021 – 26
Day 7
GroupValue95% CI
Moderate AH DUR-928 30 mg17.016 – 19
Moderate AH DUR-928 90 mg17.011 – 19
Severe AH DUR-928 30 mg23.521 – 29
Severe AH DUR-928 90 mg24.021 – 29
Severe AH DUR-928 150 mg24.021 – 28
Day 28
GroupValue95% CI
Moderate AH DUR-928 30 mg15.012 – 20
Moderate AH DUR-928 90 mg11.58 – 15
Severe AH DUR-928 30 mg19.016 – 24
Severe AH DUR-928 90 mg23.517 – 28
Severe AH DUR-928 150 mg23.019 – 29
Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline Primary · Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28

The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643)

Day 7
GroupValue95% CI
Moderate AH DUR-928 30 mg-5.00-10.5 – 6.7
Moderate AH DUR-928 90 mg-10.53-21.4 – -5.0
Severe AH DUR-928 30 mg0.00-8.7 – 3.6
Severe AH DUR-928 90 mg0.00-4.0 – 3.6
Severe AH DUR-928 150 mg0.00-4.3 – 3.7
Day 28
GroupValue95% CI
Moderate AH DUR-928 30 mg-20.00-21.1 – 0.00
Moderate AH DUR-928 90 mg-33.93-42.9 – -25.0
Severe AH DUR-928 30 mg-26.76-35.7 – 14.3
Severe AH DUR-928 90 mg-8.00-19.0 – 8.3
Severe AH DUR-928 150 mg0.00-29.6 – 11.5
Serum Cytokeratin 18 (M30) Secondary · Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28

Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.

Day 1-Predose
GroupValue95% CI
Moderate AH DUR-928 30 mg723.5334 – 2255
Moderate AH DUR-928 90 mg737467 – 4000
Severe AH DUR-928 30 mg1443.5561 – 4000
Severe AH DUR-928 90 mg1946292 – 4000
Severe AH DUR-928 150 mg931752 – 1766
Day 7
GroupValue95% CI
Moderate AH DUR-928 30 mg526257 – 3150
Moderate AH DUR-928 90 mg31122124 – 3440
Severe AH DUR-928 30 mg3305.5500 – 4000
Severe AH DUR-928 90 mg1702.0323 – 4000
Severe AH DUR-928 150 mg1012.5439 – 4000
Day 28
GroupValue95% CI
Moderate AH DUR-928 90 mg2205.5411 – 4000
Severe AH DUR-928 30 mg1114.0612 – 3160
Severe AH DUR-928 90 mg550.5243 – 4000
Severe AH DUR-928 150 mg161.0108 – 4000
Serum Cytokeratin 18 (M65) Secondary · Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28

Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.

Day 1-Predose
GroupValue95% CI
Moderate AH DUR-928 30 mg252.5217 – 2074
Moderate AH DUR-928 90 mg1791.0729 – 14208
Severe AH DUR-928 30 mg3033.5750 – 20000
Severe AH DUR-928 90 mg4071.5225 – 20000
Severe AH DUR-928 150 mg1999.01777 – 2209
Day 7
GroupValue95% CI
Moderate AH DUR-928 30 mg353.0119 – 3029
Moderate AH DUR-928 90 mg4697.04416 – 9928
Severe AH DUR-928 30 mg7303.0709 – 20000
Severe AH DUR-928 90 mg4397.5234 – 20000
Severe AH DUR-928 150 mg3994.5502 – 15028
Day 28
GroupValue95% CI
Moderate AH DUR-928 90 mg4771.5807 – 8736
Severe AH DUR-928 30 mg2426.0998 – 7420
Severe AH DUR-928 90 mg1224.5224 – 17232
Severe AH DUR-928 150 mg1987.0452 – 3246
International Normalized Ratio (INR) - Percent Change From Baseline Secondary · Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28

ITT population. INR (international normalized ratio) is a standardized number based on the prothrombin time and calculated by the clinical lab. INR measures the time it takes for blood to clot in vitro and measures, among other things, liver synthetic function.

Day 7 Percent Change from Baseline
GroupValue95% CI
Moderate AH DUR-928 30 mg-10.000-11.11 – 7.35
Moderate AH DUR-928 90 mg-3.226-8.33 – 7.14
Severe AH DUR-928 30 mg4.768-8.88 – 10.53
Severe AH DUR-928 90 mg0.000-5.26 – 43.75
Severe AH DUR-928 150 mg0.000-8.33 – 6.67
Day 28 Percent Change from Baseline
GroupValue95% CI
Moderate AH DUR-928 30 mg-3.676-22.22 – 0.00
Moderate AH DUR-928 90 mg0.0000.00 – 0.00
Severe AH DUR-928 30 mg-19.402-29.68 – 17.65
Severe AH DUR-928 90 mg-3.180-21.05 – 18.75
Severe AH DUR-928 150 mg0.000-33.33 – 42.11
Bilirubin - Percent Change From Baseline Secondary · Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28

ITT population

Day 7 Percent Change from Baseline
GroupValue95% CI
Moderate AH DUR-928 30 mg-15.69-34.5 – 17.1
Moderate AH DUR-928 90 mg-31.03-43.9 – -29.3
Severe AH DUR-928 30 mg-25.19-49.8 – -9.0
Severe AH DUR-928 90 mg-6.48-25.1 – 6.6
Severe AH DUR-928 150 mg4.96-29.3 – 24.7
Day 28 Percent Change from Baseline
GroupValue95% CI
Moderate AH DUR-928 30 mg-27.27-40.0 – -5.9
Moderate AH DUR-928 90 mg-74.27-75.6 – -72.9
Severe AH DUR-928 30 mg-56.93-74.1 – 34.0
Severe AH DUR-928 90 mg-34.82-47.9 – 50.0
Severe AH DUR-928 150 mg-10.04-63.6 – 1.5
Serum Creatinine (sCR) Secondary · Baseline (Screening or Day 1 Pre-dose)

Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD

Baseline (Screening)
GroupValue95% CI
Moderate AH DUR-928 30 mg0.6200.46 – 0.80
Moderate AH DUR-928 90 mg0.7100.2 – 0.84
Severe AH DUR-928 30 mg0.7950.63 – 1.20
Severe AH DUR-928 90 mg0.7650.59 – 1.50
Severe AH DUR-928 150 mg0.6100.50 – 1.00
Baseline (Day 1-Pre dose)
GroupValue95% CI
Moderate AH DUR-928 90 mg0.6600.66 – 0.66
Severe AH DUR-928 30 mg0.6400.61 – 0.78
Severe AH DUR-928 90 mg0.5800.58 – 0.58
Severe AH DUR-928 150 mg0.5200.50 – 0.70

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Moderate AH DUR-928 30 mg
Serious: 2/4 (50%)
Deaths: 0/4
Moderate AH DUR-928 90 mg
Serious: 0/3 (0%)
Deaths: 0/3
Severe AH DUR-928 30 mg
Serious: 2/4 (50%)
Deaths: 0/4
Severe AH DUR-928 90 mg
Serious: 1/4 (25%)
Deaths: 0/4
Severe AH DUR-928 150 mg
Serious: 0/4 (0%)
Deaths: 0/4

Serious adverse events (7 terms)

ReactionSystemModerate AH DUR-928 30 mgModerate AH DUR-928 90 mgSevere AH DUR-928 30 mgSevere AH DUR-928 90 mgSevere AH DUR-928 150 mg
AnemiaBlood and lymphatic system disorders—————
Abdominal painGastrointestinal disorders—————
AscitesGastrointestinal disorders—————
HematemesisGastrointestinal disorders—————
Fluid overloadMetabolism and nutrition disorders—————
HypokalemiaMetabolism and nutrition disorders—————
HeadacheNervous system disorders—————
Other adverse events (20 terms — click to expand)

ReactionSystemModerate AH DUR-928 30 mgModerate AH DUR-928 90 mgSevere AH DUR-928 30 mgSevere AH DUR-928 90 mgSevere AH DUR-928 150 mg
NauseaGastrointestinal disorders—————
DiarrhoeaGastrointestinal disorders—————
Food poisoningGastrointestinal disorders—————
DehydrationMetabolism and nutrition disorders—————
HyperglycaemiaMetabolism and nutrition disorders—————
HyperkalaemiaMetabolism and nutrition disorders—————
InsomniaPsychiatric disorders—————
AcneSkin and subcutaneous tissue disorders—————
Pruritus generalisedSkin and subcutaneous tissue disorders—————
RashSkin and subcutaneous tissue disorders—————
LeukocytosisBlood and lymphatic system disorders—————
Blood alkaline phosphatase increasedInvestigations—————
Weight increasedInvestigations—————
HypoaesthesiaNervous system disorders—————
Acute kidney injuryRenal and urinary disorders—————
Renal painRenal and urinary disorders—————
ContusionInjury, poisoning and procedural complications—————
CoughRespiratory, thoracic and mediastinal disorders—————
RhinorrhoeaRespiratory, thoracic and mediastinal disorders—————
Sinus congestionRespiratory, thoracic and mediastinal disorders—————

Most-reported serious reactions: Anemia, Abdominal pain, Ascites, Hematemesis, Fluid overload, Hypokalemia, Headache.

Data from ClinicalTrials.gov NCT03432260 adverse events section.

Sponsor's own description

This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The knowns and unknowns of treatment for alcoholic hepatitis.
    Sehrawat TS, Liu M, Shah VH. · · 2020 · cited 76× · PMID 32277902 · DOI 10.1016/s2468-1253(19)30326-7
  2. Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis.
    Hassanein T, McClain CJ, Vatsalya V, Stein LL, et al · · 2024 · cited 32× · PMID 37011138 · DOI 10.14309/ajg.0000000000002275
  3. Alcohol-related liver disease (ALD): current perspectives on pathogenesis, therapeutic strategies, and animal models.
    Hong X, Huang S, Jiang H, Ma Q, et al · · 2024 · cited 24× · PMID 39669199 · DOI 10.3389/fphar.2024.1432480
  4. Alcohol-associated liver disease: Natural history, management and novel targeted therapies.
    Alvarado-Tapias E, Pose E, Gratacós-Ginès J, Clemente-Sánchez A, et al · · 2025 · cited 21× · PMID 39481875 · DOI 10.3350/cmh.2024.0709
  5. Emerging medical therapies for severe alcoholic hepatitis.
    Tornai D, Szabo G. · · 2020 · cited 19× · PMID 32981291 · DOI 10.3350/cmh.2020.0145
  6. Targeting Liver X Receptors for the Treatment of Non-Alcoholic Fatty Liver Disease.
    Kim H, Park C, Kim TH. · · 2023 · cited 17× · PMID 37174692 · DOI 10.3390/cells12091292
  7. Moderate Alcoholic Hepatitis.
    Clemente-Sánchez A, Oliveira-Mello A, Bataller R. · · 2021 · cited 13× · PMID 34229838 · DOI 10.1016/j.cld.2021.03.001
  8. Alcohol-related hepatitis: A review article.
    Chaudhry H, Sohal A, Iqbal H, Roytman M. · · 2023 · cited 12× · PMID 37213401 · DOI 10.3748/wjg.v29.i17.2551

Verify or expand the search:

Other trials of DUR-928 30 mg

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03432260.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing