Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06700538 | A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus | PHASE1 | RECRUITING | 180 | — | — | Dec 4, 2024 | Jan 17, 2028 | Apr 24, 2026 | 3 | New Zealand |
| Arm | Type | Description |
|---|---|---|
| Part 1: ARO-INHBE | EXPERIMENTAL | ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses |
| Part 1: Placebo | PLACEBO_COMPARATOR | Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses |
| Part 2: ARO-INHBE + Tirzepatide | EXPERIMENTAL | 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 |
| Part 2: Placebo + Tirzepatide | PLACEBO_COMPARATOR | Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169 |
| Part 3: ARO-INHBE | EXPERIMENTAL | ARO-INHBE on Days 1, 85, 169, and 253 |
| Part 3: Placebo | PLACEBO_COMPARATOR | Placebo doses on Days 1, 85, 169, and 253 |
| Part 3: ARO-INHBE + Tirzepatide | EXPERIMENTAL | 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 |
| Part 3: Placebo + Tirzepatide | PLACEBO_COMPARATOR | 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 |
| Name | Type | Description |
|---|---|---|
| ARO-INHBE | DRUG | Subcutaneous (SC) injection |
| Placebo | DRUG | Calculated volume to match active treatment by SC injection |
| Tirzepatide | DRUG | SC injection |
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 gl...