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ARO-ALK7 · 1 trial · 2 indications
| 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 Day 15 through Day 253 |
| Part 2: Placebo + Tirzepatide | PLACEBO_COMPARATOR | Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253 |
| Name | Type | Description |
|---|---|---|
| ARO-ALK7 | DRUG | Subcutaneous (SC) injection |
| Placebo | DRUG | calculated volume to match active treatment by SC injection |
Inclusion Criteria: * Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m\^2), inclusive, with weight at Screening not to exceed 159 kg (350 pounds \[lbs\]) * At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * No abnormal...
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ARO-ALK7 is an investigational small molecule being developed for the treatment of obesity. It is also being studied in adults with obesity who have type 2 diabetes mellitus. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ARO-ALK7 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARWR. The company is conducting a first-in-human study of the drug in adults with obesity, with and without type 2 diabetes.
ARO-ALK7 is in Phase 1 clinical development. It is currently being evaluated in a first-in-human study that is recruiting participants. The drug is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of obesity.
ARO-ALK7 is being studied in a Phase 1 clinical trial with the identifier NCT06937203. This is a first-in-human, randomized, double-blind, placebo-controlled study in adults with obesity, with and without type 2 diabetes mellitus. The trial is recruiting participants in Australia and New Zealand and aims to enroll 150 people.
ARO-ALK7 is a small molecule designed to target the activin receptor-like kinase 7 (ALK7) pathway, which is involved in metabolic regulation. By modulating this pathway, the drug aims to address obesity. However, the specific mechanism of action has not been fully detailed in available information.