Recruiting
A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
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).
ClinicalTrials.gov IDNCT06937203
PhasePHASE1, PHASE2
Enrollment150
SponsorArrowhead Pharmaceuticals
Age18 Years
SexALL
Conditions studied
Obesity, Diabetes Mellitus, Type 2
About this study
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: ARO-ALK7 — Subcutaneous (SC) injection
- Drug: Placebo — calculated volume to match active treatment by SC injection
Primary outcomes
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Up to Day 253 End of Study (EOS))
Eligibility information
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
- Research Site 8, Morayfield, QLC 4506 Australia
- Research Site 7, Nedlands, Western Australia 6009 Australia
- Research Site 5, Grafton, Auckland 1010 New Zealand
- Research Site 6, Papatoetoe, Auckland 2025 New Zealand
- Research Site 3, Takapuna, Auckland 0622 New Zealand
- Research Site 1, Auckland, 1010 New Zealand
- Research Site 2, Christchurch, 8011 New Zealand
- Research Site 4, Rotorua, 3010 New Zealand
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.