Evaluating ARO-INHBE for treating obesity in adults
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
This study is testing a new treatment called ARO-INHBE to see if it can help adults with obesity, including those with obesity and type 2 diabetes, feel better and manage their weight.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Arrowhead Pharmaceuticals Industry-sponsored |
| Locations | 3 sites (Grafton, Auckland and 2 other locations) |
| Trial ID | NCT06700538 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1/2a double-blind study designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in adults with obesity. The study consists of two parts: the first part focuses on participants with obesity, while the second part includes those with obesity and type 2 diabetes mellitus who are also receiving tirzepatide. Participants will receive either ARO-INHBE or a placebo, and their responses will be closely monitored throughout the study. The goal is to determine the effectiveness and safety of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a Body Mass Index (BMI) between 30 to 50 kg/m2 who have made unsuccessful attempts at weight loss through lifestyle changes.
Not a fit: Patients who do not meet the obesity criteria or those with significant health issues that could affect safety or study results may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for weight management in adults with obesity, potentially improving their overall health and quality of life.
How similar studies have performed: Other studies have shown promise in using similar pharmacological approaches for obesity management, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Grafton, Auckland and 2 other locations
- Research Site 1 — Grafton, Auckland, New Zealand (Recruiting)
- Research Site 3 — Auckland, New Zealand (Recruiting)
- Research Site 2 — Christchurch, New Zealand (Recruiting)
Study contacts
- Study coordinator: Medical Monitor
- Email: AROINHBE@arrowheadpharma.com
- Phone: 626-304-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.