ARO-INHBE for Obesity
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive single or multiple ascending doses of ARO-INHBE or placebo on Days 1 and 29
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
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
ARO-INHBE at ascending doses on Days 1, 85, 169, and 253 plus weekly doses of tirzepatide (2.5 to 15 mg \[or the maximally tolerated dose\]) starting Day 15 through Day 365
ARO-INHBE on Days 1, 85, 169, and 253
ARO-INHBE at ascending doses on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 milligrams \[mg\]) starting Day 15 through Day 169
ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses
Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses
Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169
Placebo doses on Days 1, 85, 169, and 253
Placebo doses on Days 1, 85, 169, and 253 plus weekly doses of tirzepatide (2.5 to 15 mg \[or the maximally tolerated dose\]) starting Day 15 through Day 365
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arrowhead Pharmaceuticals
Lead Sponsor
Citations
1.
arrowheadpharma.com
arrowheadpharma.com/en-us/newsroom/arrowhead-pharmaceuticals-files-regulatory-clearance-initiate-3Arrowhead 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 ...
2.
synapse.patsnap.com
synapse.patsnap.com/article/arrowhead-pharmaceuticals-to-advance-two-new-rnai-based-obesity-candidates-into-clinical-trialsArrowhead 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 Announces Interim Clinical ...
ARO-INHBE in combination with tirzepatide achieved -9.4% weight loss at week 16 in obese patients with type 2 diabetes mellitus, ...
9.
arrowheadpharma.com
arrowheadpharma.com/en-us/newsroom/arrowhead-pharmaceuticals-requests-regulatory-clearance-initiateArrowhead 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.
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