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-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Subcutaneous (SC) injection
calculated volume to match active treatment by SC injection
Research Site 8
Morayfield, QLC, Australia
RECRUITINGResearch Site 7
Nedlands, Western Australia, Australia
NOT_YET_RECRUITINGResearch Site 5
Grafton, Auckland, New Zealand
RECRUITINGResearch Site 6
Papatoetoe, Auckland, New Zealand
RECRUITINGResearch Site 3
Takapuna, Auckland, New Zealand
RECRUITINGResearch Site 1
Auckland, New Zealand
RECRUITINGResearch Site 2
Christchurch, New Zealand
RECRUITINGResearch Site 4
Rotorua, New Zealand
RECRUITINGNumber of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 253 End of Study (EOS)
Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-∞)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F)
Time frame: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after Dosing (Amount excreted: Ae)
Time frame: Through 24 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe)
Time frame: Through 24 hours post-dose
PK of ARO-ALK7: Renal Clearance (CLr)
Time frame: Through 24 hours post-dose
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