Are there clinical trials testing ivermectin as a treatment for liver fibrosis or NAFLD in humans?
Executive summary
No completed or registered human clinical trials testing ivermectin specifically as a therapy for liver fibrosis or nonalcoholic fatty liver disease (NAFLD) are identified in the provided reporting; the evidence base consists predominantly of preclinical animal and cell studies, mechanistic reports and reviews that call for further translational work before human testing [1] [2] [3] [4]. Public-facing summaries that imply clinical readiness overlook that human safety and efficacy data for these indications are lacking and that ivermectin has known, if uncommon, liver-related adverse signals from other uses [5] [6] [7].
1. Preclinical promise, not proof: what the animal and cell work shows
Multiple independent laboratories report that ivermectin and related avermectin compounds reduce fibrotic markers, suppress hepatic stellate cell activation, or limit lipid accumulation in rodent models and hepatocyte lines—examples include CCl4- and methotrexate-induced fibrosis models and steatosis-induced HepG2 cells, which together form the core preclinical rationale for repurposing (Ying et al. and MDPI reports on CCl4 models; methotrexate rat study; HepG2 steatosis work) [1] [2] [8] [9].
2. A plausible mechanism—FXR engagement and anti‑fibrotic pathways—but still experimental
Mechanistic studies suggest that ivermectin and avermectin analogues can act on the farnesoid X receptor (FXR) and modulate metabolic and fibrotic pathways in rodents, a biologically plausible route to affect NAFLD and fibrosis; however, these are pharmacology and signaling findings in animals/cells rather than demonstration of therapeutic benefit in humans [3] [10].
3. No human clinical trials found in the supplied reporting
The assembled sources and clinical-trial pointers in the dataset show reviews, institutional trial listings for NAFLD generally, and translational reviews calling for human studies, but none documents a completed or ongoing randomized clinical trial of ivermectin for NAFLD or liver fibrosis in humans; major clinical-trial trackers or academic trial pages in the dataset (e.g., UCSF NAFLD trials) do not list ivermectin among investigational agents [11] [4] [12].
4. Safety signals and practical cautions from human use in other diseases
Experience with ivermectin in humans—chiefly as an antiparasitic and more recently in trials for COVID-19—shows generally well-tolerated dosing but also reports of aminotransferase elevations and rare clinically apparent liver injury; liver-specific safety has not been established in patients with chronic liver disease or NAFLD, and some reviewers urge caution until clinical pharmacokinetics and toxicity are defined for such repurposing (LiverTox review; COVID-era analyses) [6] [13] [7].
5. What the reviews and experts say about next steps
Recent reviews of therapies for liver fibrosis and NAFLD note ivermectin as a candidate identified in preclinical screens and conceptual work, but they underscore that translation requires pharmacokinetic, dose-finding, safety and eventually randomized efficacy trials in humans—points emphasizing that preclinical efficacy alone is insufficient to justify clinical use [4] [12].
6. Alternative viewpoints and possible agendas to watch
Some commercial or popular articles summarize the animal data as “may help” for fatty liver and could overstate readiness for clinical application; concurrently, patent literature and basic-science enthusiasm (including interest in FXR-modulating analogues) create an intellectual-property and translational incentive to pursue human studies—but those incentives do not equate to existing human trial evidence [7] [10]. Reporting that skips the translational gap risks encouraging off-label use before safety and efficacy are proven.