DRUG
ARO-ALK7
Subcutaneous (SC) injection
Status
Recruiting
Phase
Phase 1 / Phase 2
Enrollment
150
Locations
8
Results
Not posted
Publications
0
Study summary
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).
Interventions
DRUG
Subcutaneous (SC) injection
DRUG
calculated volume to match active treatment by SC injection
Timeline
First posted
Apr 22, 2025
Study start
May 9, 2025
Primary completion
Feb 2027
Study completion
Feb 2027
Results posted
Not reported
Registry updated
Jul 8, 2026
Outcomes
Number 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
Eligibility
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 finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results * Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of childbearing potential must agree to use a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later Exclusion Criteria: * Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening * Use of glucagon-like peptide-1 receptor agonist (GLP-1RAs) (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening * Use of non-GLP-1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate, and other prescription or over-the-counter medication or supplement taken for weight loss purposes * Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome) * History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures) * Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening * Type 1 diabetes mellitus Note: Additional inclusion/exclusion criteria may apply per protocol.
Study locations
Australia · New Zealand. Showing up to 24 locations stored in the fast local snapshot.
Research Site 8
Morayfield, QLC, Australia
Research Site 7
Nedlands, Western Australia, Australia
Research Site 5
Grafton, Auckland, New Zealand
Research Site 6
Papatoetoe, Auckland, New Zealand
Research Site 3
Takapuna, Auckland, New Zealand
Research Site 1
Auckland, New Zealand
Research Site 2
Christchurch, New Zealand
Research Site 4
Rotorua, New Zealand
Publications
No PMID-linked publications were present in this registry snapshot.
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