Clinical trial for Obesity
Official title A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT06700538
What this study is testing
What is ARO-INHBE?
ARO-INHBE is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Obesity, defined as Body Mass Index (BMI) between 30 to 50 kilograms (kg)/square meter (m\^2) at Screening
- At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
- Type 2 diabetes mellitus for at least 6 months prior to Screening, with glycated hemoglobin (HgbA1c) between 6.0% (42 millimole [mmol]/mole [mol])...
- Willing, able and motivated to comply with all study assessments and adhere to the protocol schedule, including adherence to a stable diet and...
- No abnormal finding of clinical relevance at Screening that, in the opinion of investigator, could adversely impact participant safety or adversely...
You likely can't join if
- Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening
- Use of glucagon-like protein 1 receptor (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...
- Obesity attributable, in the investigator's opinion, to medication use, monogenic, or endocrinologic disorders (other than polycystic ovary syndrome)
- History or prior surgical or device-based therapy for obesity
- Use of medications strongly associated with weight gain within 3 months prior to Screening
See the full eligibility criteria
- Obesity, defined as Body Mass Index (BMI) between 30 to 50 kilograms (kg)/square meter (m\^2) at Screening
- At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
- Type 2 diabetes mellitus for at least 6 months prior to Screening, with glycated hemoglobin (HgbA1c) between 6.0% (42 millimole [mmol]/mole [mol]) and 9.5% (80 mmol/mol) at Screening, on a stable diabetes medication...
- 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 participant safety or adversely impact study results
- Participants of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days following the end of the study or last dose of study medication, whichever is later...
- Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening
- Use of glucagon-like protein 1 receptor (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...
- Obesity attributable, in the investigator's opinion, to medication use, monogenic, or endocrinologic disorders (other than polycystic ovary syndrome)
- 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 \ 6.0 milli-international units (mIU)/liter (L) at Screening
- Evidence of clinically significant end-organ disease Note: Other Inclusion/Exclusion criteria may apply per protocol
The study team makes the final eligibility decision.
Where it's taking place
- Camberwell, Australia
- Charlestown, Australia
- Maroochydore, Australia
- Sydney, Australia
- Chicoutimi, Canada
- Concord, Canada
- Toronto, Canada
- Tbilisi, Georgia
- Grafton, Auckland, New Zealand
- Auckland, New Zealand
- Christchurch, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camberwell, Australia; Charlestown, Australia; Maroochydore, Australia; Sydney, Australia; Chicoutimi, Canada; Concord, Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.