ARO-INHBE / Arrowhead Pharmaceuticals - LARVOL DELTA

ARO‑INHBE demonstrates clinically meaningful reductions in liver fat as monotherapy and in combination with low-dose tirzepatide in adults with obesity (EASL 2026) - "RNAi‑mediated silencing of INHBE with ARO-INHBE was well-tolerated and produced clinically meaningful reductions in LFC as monotherapy or combination therapy with low-dose tirzepatide in individuals with obesity with and without T2DM. Targeting Activin E may represent a novel therapeutic strategy for MASH and obesity‑related metabolic dysfunction. The AROINHBE-1001 study is ongoing."

Clinical • Combination therapy • Late-breaking abstract • Monotherapy • Diabetes • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

Arrowhead Pharmaceuticals Presents New Clinical Data on RNAi-based Obesity and MASH Candidate ARO-INHBE at EASL 2026 (Businesswire) - "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)."

P1/2 data • Obesity • Type 2 Diabetes Mellitus

AROINHBE-1001: A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | N=120 ➔ 180 | Trial completion date: May 2026 ➔ Jan 2028 | Trial primary completion date: May 2026 ➔ Sep 2027

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

The Phase 1/2a studies of ARO-INHBE and ARO-ALK7 are ongoing... (Businesswire) - "...Company expects to report and present additional results in 2026....Company hosting a virtual KOL webinar today, January 6, 2026, at 11:30 am EST to discuss results."

P1/2 data • Obesity • Type 2 Diabetes Mellitus

Select ARO-INHBE Phase 1/2a Results (Businesswire) - "A single dose of ARO-INHBE in adult volunteers with obesity (n= 4 per dose level) achieved a dose dependent reduction in serum Activin E with a mean maximum reduction of -85% after a single 400 mg dose and a maximum observed reduction of -94%...Single dose ARO-INHBE monotherapy at week 16 led to: Mean visceral fat reduction of -9.9%; Mean liver fat relative reduction of -38%; Increased total lean tissue of 3.6%...Two doses of ARO-INHBE monotherapy at Week 24 achieved: Mean visceral fat reduction of -15.6%, adjusted for placebo."

P1/2 data • Obesity • Type 2 Diabetes Mellitus

AROINHBE-1001: Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | Phase classification: P1 ➔ P1/2 | N=78 ➔ 120

Enrollment change • Phase classification • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Select ARO-INHBE Preclinical Results (Businesswire) - "In a diet-induced obese (DIO) mouse model, hepatic INHBE silencing with siRNA led to a 19% suppression in body weight gain relative to vehicle controls. Treated mice exhibited improved body composition with a 22% reduction of fat mass while preserving lean mass. Treated mice also demonstrated a trend to improved glycemic control. Hepatic INHBE silencing in DIO mice enhanced catecholamine sensitivity, increasing lipid mobilization and oxidation, which was not associated with liver steatosis. In fact, treated animals showed less liver fat accumulation relative to saline controls...Dosing in the ARO-INHBE study was initiated in December 2024 with initial data possible by year end 2025."

P1 data • Preclinical • Metabolic Disorders • Obesity

AROINHBE-1001: Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-INHBE for the Treatment of Obesity (Businesswire) - "Arrowhead Pharmaceuticals, Inc...today announced that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity."

Trial status • Diabetes • Obesity

Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: Arrowhead Pharmaceuticals

New P1 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Liver-Specific Silencing of INHBE with ARO-INHBE, an siRNA Therapeutic, for Metabolic Diseases (ADA 2024) - "ARO-INHBE effectively silences hepatic INHBE mRNA. In the DIO mouse model, liver-specific silencing of INHBE mRNA caused the suppression of fat mass gain, but preservation of LBM. A clinical lead siRNA targeting INHBE has been selected."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus