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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06937203




Registration number
NCT06937203
Ethics application status
Date submitted
15/04/2025
Date registered
22/04/2025
Date last updated
5/06/2025

Titles & IDs
Public title
Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus
Scientific title
A Phase 1/2A Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
AROALK7-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARO-ALK7
Treatment: Drugs - Placebo

Experimental: Part1: ARO-ALK7 - ARO-ALK7 in single (Day 1) or multiple (Days 1 and 85) ascending doses

Placebo comparator: Part 1: Placebo - Placebo in single (Day 1) or multiple (Days 1 and 85) matching doses

Experimental: Part:2: ARO-ALK7 + Tirzepatide - ARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253

Placebo comparator: Part 2: Placebo + Tirzepatide - Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253


Treatment: Drugs: ARO-ALK7
SC injection

Treatment: Drugs: Placebo
calculated volume to match active treatment by SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to Day 253 End of Study (EOS)
Secondary outcome [1] 0 0
Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)
Timepoint [1] 0 0
Through 48 hours post-dose
Secondary outcome [2] 0 0
PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)
Timepoint [2] 0 0
Through 48 hours post-dose
Secondary outcome [3] 0 0
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Timepoint [3] 0 0
Through 48 hours post-dose
Secondary outcome [4] 0 0
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Timepoint [4] 0 0
Through 48 hours post-dose
Secondary outcome [5] 0 0
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-8)
Timepoint [5] 0 0
Through 48 hours post-dose
Secondary outcome [6] 0 0
PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2)
Timepoint [6] 0 0
Through 48 hours post-dose
Secondary outcome [7] 0 0
PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F)
Timepoint [7] 0 0
Through 48 hours post-dose
Secondary outcome [8] 0 0
PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F)
Timepoint [8] 0 0
Through 48 hours post-dose
Secondary outcome [9] 0 0
PK of ARO-ALK7 (Part 1 Only): Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after Dosing (Amount excreted: Ae)
Timepoint [9] 0 0
Through 24 hours post-dose
Secondary outcome [10] 0 0
PK of ARO-ALK7 (Part 1 Only): Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe)
Timepoint [10] 0 0
Through 24 hours post-dose
Secondary outcome [11] 0 0
PK of ARO-ALK7: Renal Clearance (CLr)
Timepoint [11] 0 0
Through 24 hours post-dose

Eligibility
Key inclusion criteria
* Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 lbs)
* At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
* No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study 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 end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, 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 GLP-1RAs (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
* Use of non-GLP-1R 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 supplement taken for weight loss purposes
* Obesity attributable primarily to medication use, endocrinologic or monogenic disorders
* History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures)
* Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening
* Type 1 diabetes mellitus

Note: Additional 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
29/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/12/2026
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arrowhead Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Monitor
Address 0 0
Country 0 0
Phone 0 0
626-304-3400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT06937203