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Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus

NCT ID: NCT06937203

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2026-07-31

Brief Summary

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This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult volunteers with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1) and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult volunteers with obesity with and without (T2DM) receiving tirzepatide (Part 2). In Part 1A eligible participants with obesity will be randomized to receive a single dose of ARO-ALK7 or placebo (PBO) administered on Day 1. In Part 1B, eligible participants with obesity will be randomized to receive two doses of ARO-ALK7 or PBO administered on Day 1 and Day 85. In Part 2, eligible subjects with obesity with and without (T2DM) will be randomized to combined therapy with tirzepatide and ARO-ALK7 (intervention arm) or tirzepatide and PBO (control arm). Tirzepatide will be initiated on Day 15 and administered by subcutaneous (SC) injection weekly. ARO-ALK7 or PBO will be administered by SC injection on Day 1 and Day 85. Subjects in both Part 1 and Part 2 will undergo adipose aspiration pre and post dose.

Detailed Description

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Conditions

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Obesity Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part1: ARO-ALK7

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

Group Type EXPERIMENTAL

ARO-ALK7

Intervention Type DRUG

SC injection

Part 1: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

calculated volume to match active treatment by SC injection

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

Group Type EXPERIMENTAL

ARO-ALK7

Intervention Type DRUG

SC injection

Part 2: Placebo + Tirzepatide

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

calculated volume to match active treatment by SC injection

Interventions

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ARO-ALK7

SC injection

Intervention Type DRUG

Placebo

calculated volume to match active treatment by SC injection

Intervention Type DRUG

Other Intervention Names

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0.9% NaCL

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site 8

Morayfield, QLC, Australia

Site Status RECRUITING

Research Site 7

Nedlands, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Research Site 5

Grafton, Auckland, New Zealand

Site Status RECRUITING

Research Site 6

Papatoetoe, Auckland, New Zealand

Site Status RECRUITING

Research Site 3

Takapuna, Auckland, New Zealand

Site Status RECRUITING

Research Site 1

Auckland, , New Zealand

Site Status RECRUITING

Research Site 2

Christchurch, , New Zealand

Site Status RECRUITING

Research Site 4

Rotorua, , New Zealand

Site Status RECRUITING

Countries

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Australia New Zealand

Central Contacts

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Medical Monitor

Role: CONTACT

[email protected]
626-304-3400

Other Identifiers

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AROALK7-1001

Identifier Type: -

Identifier Source: org_study_id