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RecruitingNCT06937203Updated Jul 8, 2026

A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus

A Phase 1/2 interventional study of ARO-ALK7 and Placebo in Obesity and Diabetes Mellitus, Type 2, sponsored by Arrowhead Pharmaceuticals. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Arrowhead Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).

02

Conditions studied

  • Obesity
  • Diabetes Mellitus, Type 2
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m\^2), inclusive, with weight at Screening not to exceed 159 kg (350 pounds [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
  • Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of childbearing potential must agree to use 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

Exclusion criteria

Exclusion Criteria:

  • Self-reported (or documented) weight gain or loss >5% within 3 months prior to Screening
  • Use of glucagon-like peptide-1 receptor agonist (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 in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome)
  • 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.

04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Part 1 and Part 2 (optional cohort): ARO-ALK7

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

    Drug: ARO-ALK7

  • Placebo comparator
    Part 1 and Part 2 (optional cohort): Placebo

    Placebo in single (Day 1) or multiple (Days 1 and 85) matching doses

    Drug: Placebo

  • Experimental
    Part:2: ARO-ALK7 + Tirzepatide

    ARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253

    Drug: ARO-ALK7

  • Placebo comparator
    Part 2: Placebo + Tirzepatide

    Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253

    Drug: Placebo

Interventions

  • DrugARO-ALK7

    Subcutaneous (SC) injection

  • DrugPlacebo

    calculated volume to match active treatment by SC injection

    Also known as: 0.9% sodium chloride

05

What researchers measure

Primary outcomes

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

    Time frame: Up to Day 253 End of Study (EOS)

Secondary outcomes

  1. Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)

    Time frame: Through 48 hours post-dose

  2. PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Through 48 hours post-dose

  3. PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)

    Time frame: Through 48 hours post-dose

  4. 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)

    Time frame: Through 48 hours post-dose

  5. PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-∞)

    Time frame: Through 48 hours post-dose

  6. PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2)

    Time frame: Through 48 hours post-dose

  7. PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F)

    Time frame: Through 48 hours post-dose

  8. PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F)

    Time frame: Through 48 hours post-dose

  9. PK of ARO-ALK7 (Part 1 Only): Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after Dosing (Amount excreted: Ae)

    Time frame: Through 24 hours post-dose

  10. 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)

    Time frame: Through 24 hours post-dose

  11. PK of ARO-ALK7: Renal Clearance (CLr)

    Time frame: Through 24 hours post-dose

06

Study locations

7 of 8 sites recruiting
  • Research Site 8
    Morayfield, QLC 4506, Australia
    • Principle Investigator · Principal investigator
    Recruiting
  • Research Site 7
    Nedlands, Western Australia 6009, Australia
    • Principle Investigator · Principal investigator
    Not yet recruiting
  • Research Site 5
    Grafton, Auckland 1010, New Zealand
    • Principle Investigator · Principal investigator
    Recruiting
  • Research Site 6
    Papatoetoe, Auckland 2025, New Zealand
    • Principle Investigator · Principal investigator
    Recruiting
  • Research Site 3
    Takapuna, Auckland 0622, New Zealand
    • Principle Investigator · Principal investigator
    Recruiting
  • Research Site 1
    Auckland, 1010, New Zealand
    • Principle Investigator · Principal investigator
    Recruiting
  • Research Site 2
    Christchurch, 8011, New Zealand
    • Principle Investigator · Principal investigator
    Recruiting
  • Research Site 4
    Rotorua, 3010, New Zealand
    • Principle Principle Investigator · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06937203
Lead sponsor
Arrowhead Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
May 9, 2025
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Medical Monitor
Contact
AROALK71001@arrowheadpharma.com
626-304-3400

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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