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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06937203 | A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus | PHASE1 | RECRUITING | 138 | — | — | May 9, 2025 | Oct 1, 2026 | Apr 13, 2026 | 8 | Australia, New Zealand |
| Arm | Type | Description |
|---|---|---|
| Part 1 and Part 2 (optional cohort): ARO-ALK7 | EXPERIMENTAL | ARO-ALK7 in single (Day 1) or multiple (Days 1 and 85) ascending doses |
| Part 1 and Part 2 (optional cohort): Placebo | PLACEBO_COMPARATOR | Placebo in single (Day 1) or multiple (Days 1 and 85) matching doses |
| Part:2: ARO-ALK7 + Tirzepatide | EXPERIMENTAL | ARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253 |
| Part 2: Placebo + Tirzepatide | PLACEBO_COMPARATOR | Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253 |
| Name | Type | Description |
|---|---|---|
| ARO-ALK7 | DRUG | SC injection |
| Placebo | DRUG | calculated volume to match active treatment by SC injection |
Inclusion Criteria: * Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 lbs) * At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * No abnormal finding of clinical relevance at Screening that could adv...