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

ConditionObesity
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArrowhead Pharmaceuticals

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Obesity, defined as Body Mass Index (BMI) between 30 to 50 kilograms (kg)/square meter (m²) 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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • ARO-INHBE

    Drug

    Subcutaneous (SC) injection

  • Placebo

    Drug

    Calculated volume to match active treatment by SC injection

  • Tirzepatide

    Drug

    SC injection

Treatment groups

180 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1: ARO-INHBEExperimental treatment 1 intervention
Group B: Part 1: PlaceboPlacebo comparator 1 intervention
Group C: Part 2: ARO-INHBE + TirzepatideExperimental treatment 2 interventions
Group D: Part 2: Placebo + TirzepatidePlacebo comparator 2 interventions
Group E: Part 3: ARO-INHBEExperimental treatment 1 intervention
Group F: Part 3: PlaceboPlacebo comparator 1 intervention
Group G: Part 3: ARO-INHBE + TirzepatideExperimental treatment 2 interventions
Group H: Part 3: Placebo + TirzepatidePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to Day 365

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arrowhead Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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