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Obesity

What is Obesity?

According to the World Health Organization (WHO), overweight and obesity are defined as abnormal or excessive fat accumulation that presents a risk to health. A body mass index (BMI) over 25 is considered overweight, and over 30 is obese.

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  • In  2019, an estimated 5 million noncommunicable disease (NCD) deaths were caused by higher-than-optimal BMI.
  • Rates of overweight and obesity continue to grow in adults and children. From 1990 to 2022, the percentage of children and adolescents aged 5–19 years living with obesity increased four-fold from 2% to 8% globally, while the percentage of adults 18 years of age and older living with obesity more than doubled from 7% to 16%.
  • Obesity increases the risk of many diseases including diabetes, heart disease, stroke, and more and reducing fat mass may improve patient outcomes dramatically.

2 in 5

Adults in the U.S. have obesity.

40 to 59

Age of adults where obesity is most prevalent.

Our Research

ARO-ALK7

Obesity adipose phase 1

ARO-ALK7 is designed to silence adipocyte expression of the ACVR1C gene to reduce production of Activin receptor-like kinase 7 (ALK7), which acts as a receptor in a pathway that regulates energy homeostasis in adipose tissue. In large genetic datasets, reduced ACVR1C expression has been associated with healthier adipose distribution and reduced risk of obesity-related metabolic complications. Treatment with investigational ARO-ALK7 has the potential to reduce visceral adiposity and improve lipid and glycemic parameters.

ARO-INHBE

Obesity liver phase 1

ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. INHBE is a promising genetically validated target in which loss-of-function INHBE variants in humans are associated with lower risk of obesity and metabolic diseases, such as type 2 diabetes. Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue. Intervening in this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.

Clinical Trials

planned ID: NCT06700538

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 repeat doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2). Part 2 will commence after evaluation of safety data from Part 1 multiple-dose cohorts through Day 43. The dose for Part 2 will be based upon evaluation of data from Part 1.

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

Obesity planned ID: NCT06700538

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 repeat doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2). Part 2 will commence after evaluation of safety data from Part 1 multiple-dose cohorts through Day 43. The dose for Part 2 will be based upon evaluation of data from Part 1.

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 stud
  • 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 end 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

Timeline

  • November 22, 2024

    Study First Posted

  • December 2024

    Study Start Date

  • January 2026

    Estimated Completion Date

Trial Details

Start date:

December 2024

End date:

January 2026

Participants:

78

Eligibility criteria:

18 to 65 Years Old, All Sexes, No Healthy Volunteers

Active Clinical Trials

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

Obesity planned ID: NCT06700538

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 repeat doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2). Part 2 will commence after evaluation of safety data from Part 1 multiple-dose cohorts through Day 43. The dose for Part 2 will be based upon evaluation of data from Part 1.

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 stud
  • 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 end 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

Timeline

  • November 22, 2024

    Study First Posted

  • December 2024

    Study Start Date

  • January 2026

    Estimated Completion Date

Trial Details

Start date:

December 2024

End date:

January 2026

Participants:

78

Eligibility criteria:

18 to 65 Years Old, All Sexes, No Healthy Volunteers

planned

Obesity ID: NCT06700538

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 repeat doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2). Part 2 will commence after evaluation of safety data from Part 1 multiple-dose cohorts through Day 43. The dose for Part 2 will be based upon evaluation of data from Part 1.

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Compassionate Use

Learn more about our compassionate use agreement and eligibility criteria for medicines in our pipeline that are currently in clinical development. 

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Area of Focus

Discover our areas of expertise and how we’re working to address clinical needs.

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Patients & Caregivers

See how we’re advancing science to improve the lives of patients and their loved ones.

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Science & Innovation

We’re relentless in our pursuit of altering the course of diseases.