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A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Trial sites expanded: 7 → 15 locations
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 3 of 11 entries
  2. Study sites: 5 to 7v9
  3. Study sites: 3 to 5v8
  4. Enrollment target: 120 to 180v7 Show 6 more changesShow less
    • Primary completion date: May 2026 to Sep 17, 2027
    • Study completion date: May 2026 to Jan 17, 2028
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints revised (11)
    • Study arms: 4 to 8
    • Study title expanded, about 4 words
  5. Primary and study completion dates: Feb 2026 to May 2026v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 3v5
  2. Primary and study completion dates: Jan 2026 to Feb 2026
    • Start date: Dec 21, 2024 to Dec 4, 2024
    v4
  3. Phase: Phase 1 to Phase 1/2
    • Enrollment target: 78 to 120
    • Eligibility criteria revised
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2024 to Dec 21, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-INHBE in adult participants with obesity (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).
Trial Details
NCT Number NCT06700538
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Obesity
Related terms Obesity
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov