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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06700538

Registration number

NCT06700538

Ethics application status

Date submitted

20/11/2024

Date registered

22/11/2024

Date last updated

1/04/2025

Titles & IDs

Public title

Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus

Scientific 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

Secondary ID [1]

AROINHBE-1001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

Other metabolic disorders

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - ARO-INHBE
Treatment: Drugs - Placebo
Treatment: Drugs - Tirzepatide

Experimental: Part 1: ARO-INHBE - ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses

Placebo comparator: Part 1: Placebo - Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses

Experimental: Part 2: ARO-INHBE + Tirzepatide - ARO-INHBE at ascending doses on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169

Placebo comparator: Part 2: Placebo + Tirzepatide - Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169

Treatment: Drugs: ARO-INHBE
SC injection

Treatment: Drugs: Placebo
calculated volume to match active treatment by SC injection

Treatment: Drugs: Tirzepatide
SC injection

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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

Timepoint [1]

Part 1 single dose: up to Day 113 End of Study (EOS), Part 1 multiple doses: up to Day 169 (EOS), Part 2: up to Day 169 (EOS)

Secondary outcome [1]

Pharmacokinetics (PK) of ARO-INHBE: Maximum observed Plasma Concentration (Cmax)

Timepoint [1]

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

Secondary outcome [2]

PK of ARO-INHBE: Time to Maximum Observed Plasma Concentration (Tmax)

Timepoint [2]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [3]

PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)

Timepoint [3]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [4]

PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t)

Timepoint [4]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [5]

PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-8)

Timepoint [5]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [6]

PK of ARO-INHBE: Terminal Half-life (t1/2)

Timepoint [6]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [7]

PK of ARO-INHBE: Apparent Systemic Clearance (CL/F)

Timepoint [7]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [8]

PK of ARO-INHBE: Apparent Terminal-phase Volume of Distribution (Vz/F)

Timepoint [8]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [9]

PK of ARO-INHBE: Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after dosing (amount excreted: Ae)

Timepoint [9]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [10]

PK of ARO-INHBE: Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe)

Timepoint [10]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Secondary outcome [11]

PK of ARO-INHBE: Renal Clearance (CLr)

Timepoint [11]

Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29)

Eligibility

Key inclusion criteria

* Obesity, defined as Body Mass Index (BMI) between 30 to 50 kg/m2 at Screening
* At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
* 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 subject safety or adversely impact study results
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the endo 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.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

* Self-reported (or documented) weight gain or loss >5% within 3 months prior to Screening
* Use of 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, endocrinologic or monogenic disorders
* 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 mIU/L at Screening
* Evidence of clinically significant end-organ disease

Note: Other Inclusion/Exclusion criteria may apply per protocol

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

21/12/2024

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/01/2026

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Arrowhead Pharmaceuticals

Address

Country

Ethics approval

Ethics application status

Summary

Brief 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 (Part 1), and the safety, tolerability and PD of multiple doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2).

Trial website

https://clinicaltrials.gov/study/NCT06700538

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Medical Monitor

Address

Country

Phone

626-304-3400

Fax

Email

[email protected]

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06700538