Recruiting

ARO-ALK7 for Obesity in Adults With and Without Type 2 Diabetes

What is being tested

ARO-ALK7

+ Placebo

Drug

Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 65 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2

Interventional

Study Start: May 2025

See protocol details

Summary

Principal SponsorArrowhead Pharmaceuticals

Study ContactMedical Monitor

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 7, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the safety and effects of a new drug called ARO-ALK7 in adults with obesity. The research is conducted in two parts, focusing on those with obesity without Type 2 Diabetes initially, and then including those with Type 2 Diabetes. The goal is to understand how the drug interacts with the body and how it might help manage obesity, potentially improving options for people struggling with this condition. Participants in the study will receive either the ARO-ALK7 drug or a placebo, which is a substance with no active medicine. In some parts of the study, participants will also receive a drug called tirzepatide. Both ARO-ALK7 and tirzepatide are given through injections under the skin. The study will observe how the body reacts to the drug over time and will include procedures like taking small samples of fat to analyze how the drug affects fat tissue. This research helps determine the potential benefits and any side effects of the treatment.

Official TitleA 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

NCT06937203

Principal SponsorArrowhead Pharmaceuticals

Study ContactMedical Monitor

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

4 inclusion criteria required to participate

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

Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 lbs)

7 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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

Group II

Experimental

ARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253

Group III

Placebo

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

Group IV

Placebo

Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Recruiting

Research Site 8

Morayfield, AustraliaOpen Research Site 8 in Google Maps

Recruiting

Research Site 5

Grafton, New Zealand

Recruiting

Research Site 6

Papatoetoe, New Zealand

Recruiting

Research Site 3

Takapuna, New Zealand

Recruiting

8 Study Centers