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NCT Number: NCT06937203

A First-In-Human Study of ARO-ALK7 in Adults 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).

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site 8, Morayfield, QLC, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

ARO-ALK7

Drug

Subcutaneous (SC) injection

Placebo

Drug

calculated volume to match active treatment by SC injection

Other names: 0.9% sodium chloride

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

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Monitor

CONTACT

[email protected]

626-304-3400

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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