RecruitingPhase 1Phase 2NCT06700538

A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus

A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-INHBE in Adult Volunteers With Obesity With and Without Diabetes Mellitus


Sponsor

Arrowhead Pharmaceuticals

Enrollment

180 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-INHBE in adult participants with obesity (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ARO-INHBE, a drug called Placebo, and others for people with obesity. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGARO-INHBE

Subcutaneous (SC) injection

DRUGPlacebo

Calculated volume to match active treatment by SC injection

DRUGTirzepatide

SC injection


Locations(5)

Research Site 1

Grafton, Auckland, New Zealand

Research Site 5

Auckland, New Zealand

Research Site 3

Auckland, New Zealand

Research Site 2

Christchurch, New Zealand

Research Site 4

Hamilton, New Zealand

View Full Details on ClinicalTrials.gov

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NCT06700538


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