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

April 7, 2026 updated by: Arrowhead Pharmaceuticals

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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:

  • 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: ARO-ALK7
SC injection
Placebo Comparator: Part 2: Placebo + Tirzepatide
Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253
Drug: Placebo
calculated volume to match active treatment by SC injection
Other Names:
  • 0.9% NaCL
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
SC injection
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
calculated volume to match active treatment by SC injection
Other Names:
  • 0.9% NaCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 253 End of Study (EOS)
Up to Day 253 End of Study (EOS)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)
Time Frame: Through 48 hours post-dose
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)
Time Frame: Through 48 hours post-dose
Through 48 hours post-dose
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
Through 48 hours post-dose
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
Through 48 hours post-dose
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
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2)
Time Frame: Through 48 hours post-dose
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F)
Time Frame: Through 48 hours post-dose
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F)
Time Frame: Through 48 hours post-dose
Through 48 hours post-dose
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
Through 24 hours post-dose
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
Through 24 hours post-dose
PK of ARO-ALK7: Renal Clearance (CLr)
Time Frame: Through 24 hours post-dose
Through 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arrowhead Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AROALK7-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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