Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus
NCT ID: NCT06700538
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2024-12-04
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: ARO-INHBE
ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses
ARO-INHBE
SC injection
Part 1: Placebo
Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses
Placebo
calculated volume to match active treatment by SC injection
Part 2: ARO-INHBE + Tirzepatide
ARO-INHBE at ascending doses on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169
ARO-INHBE
SC injection
Tirzepatide
SC injection
Part 2: Placebo + Tirzepatide
Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169
Placebo
calculated volume to match active treatment by SC injection
Tirzepatide
SC injection
Interventions
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ARO-INHBE
SC injection
Placebo
calculated volume to match active treatment by SC injection
Tirzepatide
SC injection
Eligibility Criteria
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Inclusion Criteria
* At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
* Willing, able and motivated to comply with all study assessments and adhere to the protocol schedule, including adherence to a stable diet and exercise routine for the duration of the study
* No abnormal finding of clinical relevance at Screening that, in the opinion of investigator, could adversely impact subject safety or adversely impact study results
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the endo of the study or last dose of study medication, whichever is later. Participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study medication, whichever is later.
Exclusion Criteria
* Use of GLP1R agonists (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
* Use of non-GLP1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate, and other prescription or over-the-counter medication or supplements taken for weight loss
* Obesity attributable, in the investigator's opinion, to medication use, endocrinologic or monogenic disorders
* History or prior surgical or device-based therapy for obesity
* Use of medications strongly associated with weight gain within 3 months prior to Screening
* Type 1 diabetes mellitus
* History of hyperthyroidism or thyroid-stimulating hormone (TSH) levels \<0.4 or \>6.0 mIU/L at Screening
* Evidence of clinically significant end-organ disease
18 Years
65 Years
ALL
No
Sponsors
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Arrowhead Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Research Site 1
Grafton, Auckland, New Zealand
Research Site 3
Auckland, , New Zealand
Research Site 2
Christchurch, , New Zealand
Countries
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Central Contacts
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Other Identifiers
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AROINHBE-1001
Identifier Type: -
Identifier Source: org_study_id