A Phase 1/2 interventional study of ARO-INHBE and Placebo in Obesity, sponsored by Arrowhead Pharmaceuticals. Active, not recruiting at 15 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Arrowhead Pharmaceuticals · Phase 1/2, Interventional, and Treatment
Among 187 studies in Obesity with a site in Australia — 56 open to participants now, 74 under way, 34 of them phase 3. Obesity · Australia.
Among the 187 studies in Obesity with a site in Australia, this one is the 83rd largest by enrollment of the 168 interventional ones, is one of 15 that started in 2024, is one of 5 in phase 1/2, reaches primary completion later than 30 of the 73 other live ones, and was the 122nd registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 190 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →56 of the 187 studies in Obesity with a site in Australia are open now, in 12 countries. Each count lists the studies.
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →187 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 15 started in 2024.
Median enrollment 184 across the 168 interventional studies, 626 across the 19 observational. Of the 96 that completed or were terminated, 14 (15%) have results posted.
129 of 187 have an industry lead sponsor. The 10 most frequent:
Arrowhead Pharmaceuticals is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 12 (50%) have results posted.
Arrowhead Pharmaceuticals has 2 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
24 of the studies in Obesity with a site in Australia that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858839Phase 3AmgenEvaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07220642Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | 2027-05-11 |
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
| NCT07226765Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy | 2027-08-30 |
| NCT05556512Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity | 2027-10 |
Among the 187 studies in Obesity with a site in Australia, from their registry updates:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Other Inclusion/Exclusion criteria may apply per protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses
Drug: ARO-INHBE
Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses
Drug: Placebo
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
Drug: ARO-INHBE · Drug: Tirzepatide
Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169
Drug: Placebo · Drug: Tirzepatide
ARO-INHBE on Days 1, 85, 169, and 253
Drug: ARO-INHBE
Placebo doses on Days 1, 85, 169, and 253
Drug: Placebo
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
Drug: ARO-INHBE · Drug: Tirzepatide
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
Drug: Placebo · Drug: Tirzepatide
Subcutaneous (SC) injection
Calculated volume to match active treatment by SC injection
SC injection
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 365
PK of ARO-INHBE: Maximum observed Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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-∞)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Oct 2027, 34 months after the start.
Of 62 phase 1/2 interventional studies under Obesity, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 36. This study's planned 34 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Sep 2027 → Oct 2027 and completion Jan 2028 → Feb 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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