Arrowhead Pharmaceuticals Presents New Clinical Data on RNAi-based Obesity and MASH Candidate ARO-INHBE at EASL 2026
- Targeting Activin E may represent a novel therapeutic strategy for metabolic dysfunction-associated steatohepatitis (MASH) and obesity‑related metabolic dysfunction
- ARO-INHBE produced meaningful reductions in liver fat content as a monotherapy or in combination with low-dose tirzepatide in individuals with obesity with or without Type 2 Diabetes Mellitus (T2DM)
- Longer exposure to ARO-INHBE silencing resulted in continued improvements in visceral fat and liver fat from Week 12 to Week 24
“Building on prior interim results from a Phase 1/2a study of ARO-INHBE, which showed encouraging signals on weight loss and improved measures of body composition in obese patients with diabetes, today we presented additional results at the EASL 2026 congress. These data provide encouraging signals on the safety, activity, and efficacy of ARO-INHBE, particularly with respect to liver fat reductions as a monotherapy or in combination with low-dose tirzepatide in patients with or without Type 2 Diabetes Mellitus,” said
The EASL 2026 poster may be accessed on the Events and Presentations page on the Investors section of the Arrowhead website.
Select ARO-INHBE Phase 1/2a Results
- In participants with obesity, dose-dependent reductions in Activin E were observed following a single administration of ARO-INHBE, with a mean maximum reduction of 85.3% achieved with ARO-INHBE 400 mg and persistent effect beyond 3 months
- Similar Activin E reductions were observed in participants with obesity and T2DM receiving two doses of ARO-INHBE (200 mg or 400 mg) in combination with tirzepatide 5 mg, demonstrating persistent effect through Week 24 with the potential for infrequent twice per year dose administration
- Participants with obesity and baseline liver fat content (LFC) greater than 8% receiving 200mg or greater of ARO-INHBE monotherapy (n=10; baseline LFC 14.5±5.1%) had a placebo-adjusted post-dose LFC reduction of 44% (t-test: p < 0.01)
- ARO-INHBE in combination with low-dose tirzepatide (5 mg) resulted in enhanced reductions in visceral adipose tissue and LFC compared to tirzepatide alone in participants with obesity with or without T2DM
- Longer exposure to ARO-INHBE resulted in continued improvements in visceral fat and LFC from Week 12 to Week 24
Safety and Tolerability
ARO-INHBE has been generally well tolerated to date as a monotherapy and in combination with tirzepatide in participants with obesity with and without type 2 diabetes. Most treatment emergent adverse events (TEAE) were mild in severity. No TEAEs led to study or study drug discontinuation. Injection site reactions were generally mild and self-limited.
About ARO-INHBE
ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. INHBE is a promising genetically validated target in which loss-of-function INHBE variants in humans are associated with improved fat distribution and lower risk of metabolic diseases, such as type 2 diabetes. Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue. Inhibiting this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.
About the AROINHBE-1001 Phase 1/2 Study
AROINHBE-1001 (NCT06700538) is a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in up to 78 adult volunteers with obesity. Part 1 of the study is designed to assess single and multiple doses of ARO-INHBE monotherapy, and Part 2 of the study is designed to assess ARO-INHBE in combination with tirzepatide, a subcutaneously administered GLP-1/GIP receptor co-agonist that has been approved in
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