Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus

Launched by ARROWHEAD PHARMACEUTICALS · Nov 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ARO-INHBE for adults with obesity, which is defined as having a Body Mass Index (BMI) between 30 and 50. The trial is split into two parts. In the first part, researchers want to understand how safe the treatment is and how the body processes it when given as a single dose or multiple doses. In the second part, they will look at the safety and effects of giving ARO-INHBE to people with obesity who also have type 2 diabetes while they are taking another medication called tirzepatide.

To be eligible for this study, participants need to be between 18 and 75 years old, have a history of unsuccessful weight loss attempts through lifestyle changes, and be committed to following a stable diet and exercise routine. Participants should not have gained or lost more than 5% of their weight in the past three months, and they should not have taken certain weight loss medications recently. Those who join the trial will receive the study treatment and will be monitored closely for safety and effectiveness. It's important for potential participants to know that they will need to follow specific guidelines during the study, including using reliable birth control if they can become pregnant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Obesity, defined as Body Mass Index (BMI) between 30 to 50 kg/m2 at Screening
• • At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
• • Willing, able and motivated to comply with all study assessments and adhere to the protocol schedule, including adherence to a stable diet and exercise routine for the duration of the study
• • No abnormal finding of clinical relevance at Screening that, in the opinion of investigator, could adversely impact subject safety 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 endo of the study or last dose of study medication, whichever is later. Participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study medication, whichever is later.
• Exclusion Criteria:
• • Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening
• • Use of GLP1R agonists (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
• • Use of non-GLP1R 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 supplements taken for weight loss
• • Obesity attributable, in the investigator's opinion, to medication use, endocrinologic or monogenic disorders
• • History or prior surgical or device-based therapy for obesity
• • Use of medications strongly associated with weight gain within 3 months prior to Screening
• • Type 1 diabetes mellitus
• • History of hyperthyroidism or thyroid-stimulating hormone (TSH) levels \<0.4 or \>6.0 mIU/L at Screening
• • Evidence of clinically significant end-organ disease
• • Note: Other Inclusion/Exclusion criteria may apply per protocol