ObesityPhase 1/2NCT06700538
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
A Phase 1/2 study testing ARO-INHBE and Tirzepatide in people with Obesity, run by Arrowhead Pharmaceuticals at 15 sites in 4 countries.
Trial 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 (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- ARO-INHBE and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 4 Dec 2024to 17 Jan 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 regimen for at least 3 months (select Part 2 and Part 3 cohorts only)
- 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. 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.
Who cannot join
- 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 or supplements taken for weight loss
- 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
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- Type 1 diabetes mellitus
- History of hyperthyroidism or thyroid-stimulating hormone (TSH) levels <0.4 or >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
Trial locations and contacts
15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 4 countries
Australia4 sites, 4 recruiting
- Recruiting
Research Site
Camberwell, 3124
- Recruiting
Research Site
Charlestown, 2290
- Recruiting
Research Site
Maroochydore, 4558
- Recruiting
Research Site
Sydney, 2019
Georgia4 sites, 4 recruiting
- Recruiting
Research Site
Tbilisi, 0102
- Recruiting
Research Site 2
Tbilisi, 0112
- Recruiting
Research Site
Tbilisi, 0112
- Recruiting
Research Site
Tbilisi, 0159
New Zealand4 sites, 4 recruiting
- Recruiting
Research Site
Auckland, 0627
- Recruiting
Research Site
Auckland, 2025
- Recruiting
Research Site
Christchurch, 8011
- Recruiting
Research Site
Grafton, Auckland, 1010
Canada3 sites, 3 recruiting
- Recruiting
Research Site
Chicoutimi, G7H 7K9
- Recruiting
Research Site
Concord, L4K 4M2
- Recruiting
Research Site
Toronto, M4G 3E8
About this study
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
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).
- Conditions
- Obesity
- Being tested
- ARO-INHBE, Placebo, Tirzepatide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-INHBEDrug
Subcutaneous (SC) injection
PlaceboDrug
Calculated volume to match active treatment by SC injection
TirzepatideDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ARO-INHBE | Experimental | ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses Receives: Drug: ARO-INHBE |
| Part 1: Placebo | Placebo comparator | Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses Receives: Drug: Placebo |
| Part 2: ARO-INHBE + Tirzepatide | Experimental | ARO-INHBE at ascending doses on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 milligrams [mg]) starting Day 15 through Day 169 Receives: Drug: ARO-INHBE; Drug: Tirzepatide |
| Part 2: Placebo + Tirzepatide | Placebo comparator | Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169 Receives: Drug: Placebo; Drug: Tirzepatide |
| Part 3: ARO-INHBE | Experimental | ARO-INHBE on Days 1, 85, 169, and 253 Receives: Drug: ARO-INHBE |
| Part 3: Placebo | Placebo comparator | Placebo doses on Days 1, 85, 169, and 253 Receives: Drug: Placebo |
| Part 3: ARO-INHBE + Tirzepatide | Experimental | ARO-INHBE at ascending doses on Days 1, 85, 169, and 253 plus weekly doses of tirzepatide (2.5 to 15 mg [or the maximally tolerated dose]) starting Day 15 through Day 365 Receives: Drug: ARO-INHBE; Drug: Tirzepatide |
| Part 3: Placebo + Tirzepatide | Placebo comparator | Placebo doses on Days 1, 85, 169, and 253 plus weekly doses of tirzepatide (2.5 to 15 mg [or the maximally tolerated dose]) starting Day 15 through Day 365 Receives: Drug: Placebo; Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 365
Secondary outcomes (11)
PK of ARO-INHBE: Maximum observed Plasma Concentration (Cmax)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29): Through 48 hours post first and second dose; Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-∞)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Terminal Half-life (t1/2)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Apparent Systemic Clearance (CL/F)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Apparent Terminal-phase Volume of Distribution (Vz/F)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after dosing (amount excreted: Ae)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Renal Clearance (CLr)
Measured: Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start4 Dec 2024
- Primary completion17 Sep 2027 (estimated)
- Study completion17 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700538
- Sponsor's protocol ID
- AROINHBE-1001
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No