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NCT06700538·Phase 1 / Phase 2·INTERVENTIONAL

A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus

TirzepatideWeight lossRecruiting

Status

Recruiting

Phase

Phase 1 / Phase 2

Enrollment

180

Locations

5

Results

Not posted

Publications

0

Study summary

What the protocol is 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).

Interventions

Treatment arms and agents.

DRUG

ARO-INHBE

Subcutaneous (SC) injection

DRUG

Placebo

Calculated volume to match active treatment by SC injection

DRUG

Tirzepatide

SC injection

Timeline

From registration to results.

  1. First posted

    Nov 22, 2024

  2. Study start

    Dec 4, 2024

  3. Primary completion

    Sep 17, 2027

  4. Study completion

    Jan 17, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jun 26, 2026

Outcomes

What the study measures.

Primary outcomes

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame · Up to Day 365

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion 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 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. Exclusion Criteria: * 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 * 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

Study locations

5 registered sites.

New Zealand. Showing up to 24 locations stored in the fast local snapshot.

Research Site 1

Grafton, Auckland, New Zealand

Research Site 5

Auckland, New Zealand

Research Site 3

Auckland, New Zealand

Research Site 2

Christchurch, New Zealand

Research Site 4

Hamilton, New Zealand

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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