Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus
Trial Parameters
Brief 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-INHBE in adult participants with obesity (Part 1), and the safety, tolerability and PD of multiple doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2).
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