NCT02684591 (ARRIVE) is a Phase 2 clinical trial of Aramchol in Nonalcoholic Fatty Liver Disease, sponsored by University of California, San Diego.

Who is sponsoring NCT02684591?

NCT02684591 is sponsored by University of California, San Diego.

What drugs are being tested in NCT02684591?

Interventions in NCT02684591: Aramchol, Placebo.

What condition does NCT02684591 study?

NCT02684591 studies Nonalcoholic Fatty Liver Disease, HIV.

Is NCT02684591 still recruiting?

NCT02684591 is currently completed. Last updated 1 July 2020.

Are results published for NCT02684591?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-01 · How we verify

NCT02684591: ARRIVE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Aramchol Versus Placebo in the Treatment of HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy: A Randomized, Double-blinded, Allocation-concealed, Placebo-controlled Clinical Trial

Completed Phase 2 Results posted Last updated 1 July 2020

What this trial tests

Phase 2 trial testing Aramchol in Nonalcoholic Fatty Liver Disease in 50 participants. Completed in 1 February 2018.

Timeline

1 January 2016

Primary endpoint
1 February 2018

1 February 2018

Quick facts

Lead sponsor	University of California, San Diego
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	50
Start date	1 January 2016
Primary completion	1 February 2018
Estimated completion	1 February 2018
Sites	1 location across United States

Drugs / interventions tested

Aramchol — full drug profile →
Placebo

Conditions studied

Nonalcoholic Fatty Liver Disease — all drugs for Nonalcoholic Fatty Liver Disease →
HIV — all drugs for HIV →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Nonalcoholic Fatty Liver Disease or HIV. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD
Time frame: 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

Sponsor's own description

A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH. Additionally, there have been no significant clinical trials for HIV patients with NAFLD and there are no approved treatment options. We plan to conduct a randomized, double-blinded, placebo-controlled clinical trial to examine the efficacy of 600 mg of Aramchol daily (including 200 mg tablet and 400 mg tablet) versus identical placebo given over 12 weeks to improve HIV-associated hepatic steatosis as measured by a validated and accurate magnetic resonance imaging (MRI)-based technique.

Publications & conference data

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

Recent Advancements in Antifibrotic Therapies for Regression of Liver Fibrosis.
Jangra A, Kothari A, Sarma P, Medhi B, et al · · 2022 · cited 34× · PMID 35563807 · DOI 10.3390/cells11091500
MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial).
Ajmera VH, Cachay E, Ramers C, Vodkin I, et al · · 2019 · cited 34× · PMID 31013363 · DOI 10.1002/hep.30674
Recent advances in understanding and managing non-alcoholic fatty liver disease.
Albhaisi S, Sanyal A. · · 2018 · cited 28× · PMID 29946426 · DOI 10.12688/f1000research.14421.1
Lessons on Drug Development: A Literature Review of Challenges Faced in Nonalcoholic Fatty Liver Disease (NAFLD) Clinical Trials.
Chen JYS, Chua D, Lim CO, Ho WX, et al · · 2022 · cited 20× · PMID 36613602 · DOI 10.3390/ijms24010158
Pathophysiological Mechanisms in Non-Alcoholic Fatty Liver Disease: From Drivers to Targets.
Santos-Laso A, Gutiérrez-Larrañaga M, Alonso-Peña M, Medina JM, et al · · 2021 · cited 14× · PMID 35052726 · DOI 10.3390/biomedicines10010046
NAFLD and HIV: Do Sex, Race, and Ethnicity Explain HIV-Related Risk?
Soti S, Corey KE, Lake JE, Erlandson KM. · · 2018 · cited 14× · PMID 29671204 · DOI 10.1007/s11904-018-0392-1
Killing hepatocellular carcinoma in the NAFLD/NASH stage: a comprehensive perspective on targeting regulated cell death.
Xi J, Lei S, Chen J, Liu J, et al · · 2025 · cited 3× · PMID 40537476 · DOI 10.1038/s41420-025-02558-x
Fatty Acid Metabolism in Health and Cancer: From Fundamental Mechanisms to Therapeutic Application.
Hang N, Zhao R, Zhang F, Guo D, et al · · 2026 · PMID 42164655 · DOI 10.1002/mco2.70749

Verify or expand the search:

Other trials of Aramchol

Trials testing the same drug.

NCT07251712 — Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet · Phase 1 · recruiting
NCT05874336 — An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol · Phase 1 · completed
NCT03774173 — Comparison of Aramchol Concentrations With Once or Twice Daily Dosing · Phase 1 · completed
NCT03760848 — Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers · Phase 1 · completed
NCT02279524 — A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH · Phase 2 · completed

Other recruiting trials for Nonalcoholic Fatty Liver Disease

Currently open trials in the same condition.

NCT07237750 — iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss · NA · recruiting
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NCT07248371 — Validating Integrative Multi-omics Approaches in Metabolic Syndrome-related Diseases · recruiting
NCT07149571 — To Explore the Value of New MR Technology in Non-invasive Quantitative Assessment of Systemic Metabolism, Disease Status · recruiting
NCT06368882 — Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty · Phase 4 · recruiting

Other University of California, San Diego trials

Trials by the same sponsor.

NCT07342543 — Guided Physical Activity Counseling for Hypertension in Primary Care · NA · not yet recruiting
NCT06505317 — Artificial Intelligence for Early Detection of Peripheral Artery Disease · NA · not yet recruiting
NCT07211802 — CKM For Safe Use of SGLT2i in Type 1 Diabetes · Phase 3 · not yet recruiting
NCT07524751 — Culturally Adapted Pain Management for Indigenous Peoples · NA · not yet recruiting
NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02684591 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
Last refreshed: 1 July 2020

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/NCT02684591.

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