Trial · NCT04006145
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
NCT04006145, Phase 2, Completed, Albireo; results first posted 2021-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH. Trials, record NCT04006145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04006145
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
- NCT number
- NCT04006145
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Albireo
- Conditions
- NAFLD, NASH
- Interventions
- Elobixibat, Placebo oral tablet
- First posted
- 2019-07-05
- Last updated
- 2026-02-05
- Results first posted
- 2021-09-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 | Week 16 | The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months | An adverse event (AE) was any untoward medical occurrence in enrolled participant regardless of causal relationship with study drug. An SAE was defined as any AE that, at any dose, resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required or prolonged hospitalization, was a congenital anomaly/birth defect or an important medical event. TEAEs were defined as AEs that were new or worsened after the first dose of study drug. |
| Secondary | Absolute Change From Baseline to Week 16 in Liver Fat Fraction | Baseline (Day 1) and Week 16 | The effect of elobixibat on liver steatosis was measured by magnetic resonance imaging (MRI) for liver fat fraction using proton density fat fraction \[PDFF\]). Baseline was defined as the last non-missing value prior to the first dose of study drug. |
| Secondary | Absolute Change From Baseline to Week 16 in Total Liver Fat | Baseline (Day 1) and Week 16 | The effect of elobixibat on liver steatosis was measured by MRI for total liver fat using whole liver fat volume. Baseline was defined as the last non-missing value prior to the first dose of study drug. |
| Secondary | Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) | Baseline (Day 1) and Week 16 | Serum samples were collected at specified timepoints to assess ALT, AST and GGT levels. Baseline was defined as the last non-missing value prior to the first dose of study drug. |
| Secondary | Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides | Baseline (Day 1) and Week 16 | Blood samples were collected at specified timepoints to assess HDL and non-HDL cholesterol levels and triglycerides. Baseline was defined as the last non-missing value prior to the first dose of study drug. |
| Secondary | Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio | Baseline (Day 1) and Week 16 | Blood samples were collected at specified timepoints to assess LDL and HDL cholesterol levels and ratio was obtained. Baseline was defined as the last non-missing value prior to the first dose of study drug. |
| Secondary | Change From Baseline to Week 16 in Total Bile Acids | Baseline (Day 1) and Week 16 | Blood samples were collected at specified timepoints to assess total bile acid levels. Baseline was defined as the last non-missing value prior to the first dose of study drug. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 | Week 16 | The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months | The safety population included all participants who were randomized and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Change From Baseline to Week 16 in Liver Fat Fraction | Baseline (Day 1) and Week 16 | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | percent of liver fat | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline to Week 16 in Total Liver Fat | Baseline (Day 1) and Week 16 | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | milliliter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) | Baseline (Day 1) and Week 16 | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | Units/liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides | Baseline (Day 1) and Week 16 | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | millimoles/liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio | Baseline (Day 1) and Week 16 | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 16 in Total Bile Acids | Baseline (Day 1) and Week 16 | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | micromoles/liter | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 | Elobixibat | -0.57 | Standard Error 0.125 | mmol/L | |
| Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 | Placebo | -0.17 | Standard Error 0.134 | mmol/L | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Elobixibat | TEAEs | 13 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Placebo | TEAEs | 10 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Elobixibat | TESAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Placebo | TESAEs | 0 | Participants | |
| Absolute Change From Baseline to Week 16 in Liver Fat Fraction | Elobixibat | -0.43 | Standard Error 1.203 | percent of liver fat | |
| Absolute Change From Baseline to Week 16 in Liver Fat Fraction | Placebo | 0.09 | Standard Error 1.299 | percent of liver fat | |
| Absolute Change From Baseline to Week 16 in Total Liver Fat | Elobixibat | -2.80 | Standard Error 36.240 | milliliter | |
| Absolute Change From Baseline to Week 16 in Total Liver Fat | Placebo | 7.95 | Standard Error 39.146 | milliliter |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Elobixibat | 23 | |
| Overall Study | STARTED | Placebo | 24 | |
| Overall Study | Received Treatment | Elobixibat | 23 | |
| Overall Study | Received Treatment | Placebo | 24 | |
| Overall Study | COMPLETED | Elobixibat | 22 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Elobixibat | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Elobixibat | 5 | 23 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 24 | |
| other | Nausea | Gastrointestinal disorders | Elobixibat | 0 | 23 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 24 | |
| other | Abdominal pain | Gastrointestinal disorders | Elobixibat | 0 | 23 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 24 | |
| other | Vomiting | Gastrointestinal disorders | Elobixibat | 0 | 23 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 24 | |
| other | Bacterial abdominal infection | Infections and infestations | Elobixibat | 1 | 23 | |
| other | Bacterial abdominal infection | Infections and infestations | Placebo | 0 | 24 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Elobixibat | 0 | 23 |
| Total, all-cause mortality | Placebo | 0 | 24 |
| Total, other adverse events | Elobixibat | 13 | 23 |
| Total, other adverse events | Placebo | 10 | 24 |
| Total, serious adverse events | Elobixibat | 0 | 23 |
| Total, serious adverse events | Placebo | 0 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Elobixibat vs Placebo: deaths from any cause | Trial comparisons |
| Elobixibat vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04006145
GET https://conductscience.org/api/trials/v1/NCT04006145/results?page=2