First-in-human ARO-ALK7 for adults with obesity, with or without type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2a double-blind, placebo-controlled, dose-escalation trial gives single and multiple doses of ARO-ALK7 to adults with obesity, first in participants without type 2 diabetes (Part 1) and then in participants with and without type 2 diabetes receiving monotherapy or combination therapy with tirzepatide (Part 2). The study’s primary focus is safety and tolerability, with collection of pharmacokinetic and pharmacodynamic data and exploratory measures of weight and metabolic outcomes. Participants are enrolled into escalating dose cohorts with placebo control and blinding to treatment assignment. The design allows early human dosing information and signals of biological effect to guide further development.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site 8
  Morayfield, Qlc, Australia Recruiting
• Research Site 5
  Grafton, Auckland, New Zealand Recruiting
• Research Site 6
  Papatoetoe, Auckland, New Zealand Recruiting
• Research Site 3
  Takapuna, Auckland, New Zealand Recruiting
• Research Site 1
  Auckland, New Zealand Recruiting
• Research Site 2
  Christchurch, New Zealand Recruiting

Study contacts

• Study coordinator: Medical Monitor
• Email: AROALK71001@arrowheadpharma.com
• Phone: 626-304-3400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.