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Clinical Trials in Australia / NCT06937203
Recruiting Phase 1/2

A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus

NCT06937203 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1/2
Started
2025-05-09
Last updated
2026-07-08

Condition(s) studied

ObesityDiabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

ARO-ALK7Placebo

ARO-ALK7: Subcutaneous (SC) injection

Placebo: calculated volume to match active treatment by SC injection

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Research Site 8 Morayfield QLC Recruiting
Research Site 7 Nedlands Western Australia Not Yet Recruiting
Research Site 5 Grafton Auckland Recruiting
Research Site 6 Papatoetoe Auckland Recruiting
Research Site 3 Takapuna Auckland Recruiting
Research Site 1 Auckland New Zealand Recruiting
Research Site 2 Christchurch New Zealand Recruiting
Research Site 4 Rotorua New Zealand Recruiting

More Arrowhead Pharmaceuticals trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06937203 on ClinicalTrials.gov ↗ ← All trials in Australia