ARO-INHBE for Obesity

Not currently recruiting at 18 trial locations
MM
Overseen ByMedical Monitor
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Arrowhead Pharmaceuticals

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ARO-INHBE, an experimental therapy for obesity. Some parts of the trial also test it in combination with tirzepatide. The goal is to assess the safety, effectiveness, and behavior of these treatments in the body. Suitable candidates include individuals with a body mass index (BMI) of 30 to 50 who have struggled to lose weight through lifestyle changes. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ARO-INHBE is generally safe for people with obesity, whether used alone or with tirzepatide. Participants in studies did not experience serious side effects, indicating its safety for humans. This treatment has aided in weight loss and reduced liver fat, offering positive outcomes for individuals with obesity. Although more information is needed to fully understand its safety, early results are promising and suggest that ARO-INHBE could be a safe option for those considering joining a clinical trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ARO-INHBE for obesity because it targets the INHBE gene, which plays a role in regulating body weight, offering a novel approach compared to most current treatments that focus on appetite suppression or fat absorption. Unlike standard options like orlistat or phentermine, which often come with dietary restrictions or side effects, ARO-INHBE aims to address the underlying genetic factors contributing to obesity. Additionally, when combined with tirzepatide, which is known for improving insulin sensitivity and promoting weight loss, this combination could potentially enhance weight reduction outcomes more effectively than existing therapies. This dual-action strategy makes it a promising candidate for those struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that ARO-INHBE, a treatment under study in this trial, can aid in weight loss and reduce body fat in people with obesity. Animal studies and early human trials suggest it may help maintain muscle during weight loss. One study found that ARO-INHBE led to a maximum weight loss of 85% and significantly reduced belly fat. In this trial, some participants will receive ARO-INHBE alone, while others will receive it with tirzepatide. Specifically, when combined with tirzepatide, ARO-INHBE resulted in a 9.4% weight loss in people with type 2 diabetes by week 16. These findings suggest ARO-INHBE could be a promising new option for managing obesity.678910

Are You a Good Fit for This Trial?

This trial is for adults with obesity (BMI between 30 and 50) who have tried but not succeeded in losing weight through lifestyle changes. Participants must be willing to follow a stable diet and exercise routine, use effective birth control if needed, and have no major health issues that could affect safety or results.

Inclusion Criteria

My BMI is between 30 to 50.
I am willing and able to follow all study rules, including keeping my diet and exercise routine stable.
I have no health issues that could risk my safety or affect the study results.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive single or multiple ascending doses of ARO-INHBE or placebo on Days 1 and 29

4 weeks
2 visits (in-person)

Treatment Part 2

Participants receive ARO-INHBE or placebo on Days 1 and 29, plus weekly doses of tirzepatide starting Day 15 through Day 169

24 weeks
Weekly visits (in-person)

Treatment Part 3

Participants receive ARO-INHBE or placebo on Days 1, 85, 169, and 253, plus weekly doses of tirzepatide starting Day 15 through Day 365

52 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ARO-INHBE
  • Tirzepatide

Trial Overview

The study tests the safety of a new drug called ARO-INHBE given alone or with tirzepatide compared to placebo. It uses different doses in people with obesity, some of whom may also have type 2 diabetes. The study is double-blind, so neither participants nor researchers know which treatment each person gets.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3: ARO-INHBE + TirzepatideExperimental Treatment2 Interventions
Group II: Part 3: ARO-INHBEExperimental Treatment1 Intervention
Group III: Part 2: ARO-INHBE + TirzepatideExperimental Treatment2 Interventions
Group IV: Part 1: ARO-INHBEExperimental Treatment1 Intervention
Group V: Part 1: PlaceboPlacebo Group1 Intervention
Group VI: Part 2: Placebo + TirzepatidePlacebo Group2 Interventions
Group VII: Part 3: PlaceboPlacebo Group1 Intervention
Group VIII: Part 3: Placebo + TirzepatidePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arrowhead Pharmaceuticals

Lead Sponsor

Trials
45
Recruited
6,200+

Citations

Arrowhead Pharmaceuticals Files for Regulatory ...

ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may preserve lean muscle mass compared to currently approved ...

Arrowhead Pharmaceuticals to Advance Two New RNAi ...

In mouse models with diet-induced obesity, both ARO-INHBE and ARO-ALK7 have shown effectiveness in reducing body weight and fat mass while ...

A First-In-Human Study of ARO-INHBE in Adults With Obesity ...

This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics ...

Arrowhead Pharmaceuticals Presents Preclinical Data on ...

INHBE knockdown may potentially lead to a suppression in body weight gain, loss of fat mass, and preservation of lean mass. 95% reduction in ...

Obesity KOL Webinar - ARO-INHBE and ARO-ALK7 Interim ...

Obesity KOL Webinar - ARO-INHBE and ARO-ALK7 Interim Clinical Data. Jan 6, 2026 11:30 AM EST. Listen to webcast ...

Arrowhead Pharmaceuticals Presents Preclinical Data on ...

INHBE knockdown may potentially lead to a suppression in body weight gain, loss of fat mass, and preservation of lean mass.

ARO-INHBE Demonstrates Clinically Meaningful ...

ARO-INHBE was well-tolerated and produced meaningful reductions in LFC as monotherapy or combination therapy with low-dose tirzepatide in ...

Arrowhead Pharmaceuticals Requests Regulatory ...

ARO-INHBE, Phase 1/2a first-in-human dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO- ...

SEC Filing | Arrowhead Pharmaceuticals Inc.

ARO-INHBE was well tolerated as monotherapy and in combination with tirzepatide in participants with obesity with and without type 2 diabetes.