New obesity drug ARO-INHBE enters human trials
NCT ID NCT06700538
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study tests an experimental drug called ARO-INHBE in 180 adults with obesity, some of whom also have type 2 diabetes. The drug is given as a shot under the skin, either alone or combined with the existing weight-loss drug tirzepatide. The main goal is to check safety and how the body processes the drug, while also looking at weight changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARO-INHBE (an experimental drug given as a shot under the skin)
- What this could lead to
- If successful, this could lead to a new weight-loss treatment that works alone or alongside existing drugs like tirzepatide.
- What could go wrong
- This is an early-phase trial with only 180 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show meaningful weight loss.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Obesity, defined as Body Mass Index (BMI) between 30 to 50 kilograms (kg)/square meter (m\^2) at Screening * At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * Type 2 diabetes mellitus for at least 6 months prior to Screening, with glycated hemoglobin (HgbA1c) between 6.0% (42 millimole \[mmol\]/mole \[mol\]) and 9.5% (80 mmol/mol) at Screening, on a stable diabetes medication regimen for at least 3 months (select Part 2 and Part 3 cohorts only) * 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 participant safety or adversely impact study results * Participants of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days following the end 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: * Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening * Use of glucagon-like protein 1 receptor (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, monogenic, or endocrinologic disorders (other than polycystic ovary syndrome) * 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 milli-international units (mIU)/liter (L) at Screening * Evidence of clinically significant end-organ disease Note: Other Inclusion/Exclusion criteria may apply per protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site 1
RECRUITINGGrafton, Auckland, 1010, New Zealand
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Research Site 2
RECRUITINGChristchurch, 8011, New Zealand
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Research Site 3
RECRUITINGAuckland, 2025, New Zealand
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Research Site 4
RECRUITINGHamilton, 3216, New Zealand
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Research Site 5
RECRUITINGAuckland, 0632, New Zealand
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Research Site 6
RECRUITINGCharlestown, Australia
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Research Site 7
RECRUITINGSydney, Australia
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