Trial · NCT02684591
Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy
NCT02684591, Phase 2, Completed, University of California, San Diego; results first posted 2019-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy. Trials, record NCT02684591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684591
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy
- NCT number
- NCT02684591
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Nonalcoholic Fatty Liver Disease, HIV
- Interventions
- Aramchol, Placebo
- First posted
- 2016-02-18
- Last updated
- 2020-07-17
- Results first posted
- 2019-08-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD | 12 weeks | To examine the efficacy of aramchol at 600 mg orally daily versus placebo in improving hepatic steatosis assessed by magnetic resonance imaging in patients with HIV-associated NAFLD |
| Secondary | Serum Alanine Aminotransferase (ALT) | 12 Weeks | To examine the efficacy of two doses of aramchol: 200 mg/tablet and 400 mg/tablet / day orally daily versus placebo in improving serum alanine aminotransferase (ALT) levels in patients with HIV-associated NAFLD |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD | 12 weeks | percentage of fat | MEDIAN | |
| SECONDARY | Serum Alanine Aminotransferase (ALT) | 12 Weeks | IU/L | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD | Aramchol 600 mg Orally Daily | 13.7 | Full Range 1.5 to 26.3 | percentage of fat | |
| Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD | Placebo | 11.1 | Full Range 2.7 to 24.3 | percentage of fat | |
| Serum Alanine Aminotransferase (ALT) | Aramchol 600 mg Orally Daily | 51 | Full Range 12 to 100 | IU/L | |
| Serum Alanine Aminotransferase (ALT) | Placebo | 35 | Full Range 14 to 83 | IU/L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aramchol 600 mg Orally Daily | 25 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Aramchol 600 mg Orally Daily | 24 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Aramchol 600 mg Orally Daily | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events14
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 | Acid Reflux | Gastrointestinal disorders | Aramchol 600 mg Orally Daily | 0 | 25 | 0 |
| other | Acid Reflux | Gastrointestinal disorders | Placebo | 1 | 25 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Aramchol 600 mg Orally Daily | 0 | 25 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 25 | 1 |
| other | Nausea | Gastrointestinal disorders | Aramchol 600 mg Orally Daily | 1 | 25 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 25 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Aramchol 600 mg Orally Daily | 1 | 25 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 25 | 0 |
| other | Cellulitis | Skin and subcutaneous tissue disorders | Aramchol 600 mg Orally Daily | 1 | 25 | 1 |
| other | Cellulitis | Skin and subcutaneous tissue disorders | Placebo | 0 | 25 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aramchol 600 mg Orally Daily | 0 | 25 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, other adverse events | Aramchol 600 mg Orally Daily | 4 | 25 |
| Total, other adverse events | Placebo | 3 | 25 |
| Total, serious adverse events | Aramchol 600 mg Orally Daily | 0 | 25 |
| Total, serious adverse events | Placebo | 0 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31013363 | DERIVED |
Source PubMed
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 |
|---|---|
| Aramchol 600 mg Orally Daily vs Placebo: deaths from any cause | Trial comparisons |
| Aramchol 600 mg Orally Daily 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/NCT02684591
GET https://conductscience.org/api/trials/v1/NCT02684591/registered