Phase 2
N=47
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
NAFLD · NASH
Bottom Line
View on ClinicalTrials.gov: NCT04006145 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 — -0.57; -0.17 "mmol/L" — p=0.029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Elobixibat (Drug); Placebo oral tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albireo
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 |
-0.57; -0.17 | 0.029 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
13; 10; 0; 0 | — |
| SECONDARY Absolute Change From Baseline to Week 16 in Liver Fat Fraction |
-0.43; 0.09 | — |
| SECONDARY Absolute Change From Baseline to Week 16 in Total Liver Fat |
-2.80; 7.95 | — |
| SECONDARY Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) |
5.04; 1.05; 2.21; 0.96; 5.12; -1.73 | — |
| SECONDARY Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides |
0.03; -0.05; -0.75; -0.23; -0.13; -0.08 | — |
| SECONDARY Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio |
-0.56; -0.11 | — |
| SECONDARY Change From Baseline to Week 16 in Total Bile Acids |
0.49; 0.33 | — |
Summary
Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)
Eligibility Criteria
Key Inclusion Criteria
- Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH
- Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% liver steatosis
- Fasting serum low density lipoprotein-cholesterol (LDL-C) >130 mg/dL at Screening, >110 mg/dL on lipid-lowering medications
Key Exclusion Criteria
- Body mass index (BMI) 2.6
- Any of the following laboratory abnormalities:
- alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) >5 × ULN
- International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy
- Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome
- Platelet count less than the lower limit of normal (LLN)
- Creatinine clearance as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation 9.5%
- Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.
- Uncontrolled hypertension
- Participants with known intolerance to MRI or with conditions contraindicated for MRI procedures
Data sourced from ClinicalTrials.gov (NCT04006145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.