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Clinical Trial Details

Trial ID: L6074
Source ID: NCT06700538
Associated Drug: Aro-Inhbe
Title: Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Obesity
Interventions: DRUG: ARO-INHBE|DRUG: Placebo|DRUG: Tirzepatide
Outcome Measures: Primary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Part 1 single dose: up to Day 113 End of Study (EOS), Part 1 multiple doses: up to Day 169 (EOS), Part 2: up to Day 169 (EOS) | Secondary: Pharmacokinetics (PK) of ARO-INHBE: Maximum observed Plasma Concentration (Cmax), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29): Through 48 hours post first and second dose|PK of ARO-INHBE: Time to Maximum Observed Plasma Concentration (Tmax), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-∞), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Terminal Half-life (t1/2), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Apparent Systemic Clearance (CL/F), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Apparent Terminal-phase Volume of Distribution (Vz/F), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after dosing (amount excreted: Ae), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)|PK of ARO-INHBE: Renal Clearance (CLr), Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)
Sponsor/Collaborators: Sponsor: Arrowhead Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-21
Completion Date: 2026-01
Results First Posted:
Last Update Posted: 2025-04-01
Locations: Research Site, Grafton, Auckland, 1010, New Zealand
URL: https://clinicaltrials.gov/show/NCT06700538