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

Sponsor
Arrowhead Pharmaceuticals
Study ID
NCT06700538
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ARO-INHBE — DRUG
    Subcutaneous (SC) injection
  • Placebo — DRUG
    Calculated volume to match active treatment by SC injection
  • Tirzepatide — DRUG
    SC injection

Study Details

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).

Key Dates

Start date
Dec 4, 2024
Status verified
Apr 2026
Primary completion
Sep 17, 2027
Completion
Jan 17, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: ARO-INHBE
    ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses
  • Placebo Comparator: Part 1: Placebo
    Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses
  • Experimental: Part 2: ARO-INHBE + Tirzepatide
    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
  • Placebo Comparator: Part 2: Placebo + Tirzepatide
    Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169
  • Experimental: Part 3: ARO-INHBE
    ARO-INHBE on Days 1, 85, 169, and 253
  • Placebo Comparator: Part 3: Placebo
    Placebo doses on Days 1, 85, 169, and 253
  • Experimental: Part 3: ARO-INHBE + Tirzepatide
    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
  • Placebo Comparator: Part 3: Placebo + Tirzepatide
    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

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 365 ]

Central Contacts

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