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NCT06700538 | RECRUITING | Obesity

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

Arrowhead Pharmaceuticals

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).

Condition or disease

Obesity

Intervention/treatment

ARO-INHBE

Placebo

Tirzepatide

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-INHBE in Adult Volunteers With Obesity With and Without Diabetes Mellitus
Actual Study Start Date : 2024-12-04
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus

Location Details

NCT06700538

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

New Zealand, Auckland

Research Site 1

Grafton, Auckland, New Zealand, 1010

RECRUITING

New Zealand,

Research Site 3

Auckland, New Zealand, 2025

RECRUITING

New Zealand,

Research Site 2

Christchurch, New Zealand, 8011