Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus

Launched by ARROWHEAD PHARMACEUTICALS · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ARO-ALK7 in adults who are overweight or obese, with some participants also having Type 2 diabetes. The main goals of the trial are to check how safe the treatment is, how well it is tolerated, and how it works in the body. In the first part of the study, participants with obesity will receive either ARO-ALK7 or a placebo (a treatment that has no active ingredients) to compare the effects. The second part will involve participants with and without diabetes receiving ARO-ALK7 along with another medication called tirzepatide, or just tirzepatide alone.

To be eligible for the trial, participants must have a body mass index (BMI) between 30 and 50, which classifies them as obese, and they need to have tried to lose weight before without success. Participants should also be generally healthy and agree to use effective birth control if they can become pregnant. The trial is not yet recruiting participants, so if someone is interested, they will need to wait for it to start. Those who join can expect to receive injections of ARO-ALK7 or a placebo on specific days and will be monitored closely throughout the study to assess their health and how the treatment is working.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 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
• • Participants of childbearing potential must agree to use highly effective contraception in addition to 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 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 to medication use, endocrinologic or monogenic disorders
• • 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