Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06937203
PHASE1/PHASE2

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

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-05-07

Completion Date

2026-07

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

DRUG

ARO-ALK7

SC injection

DRUG

Placebo

calculated volume to match active treatment by SC injection

Locations (8)

Research Site 8

Morayfield, QLC, Australia

Research Site 7

Nedlands, Western Australia, Australia

Research Site 5

Grafton, Auckland, New Zealand

Research Site 6

Papatoetoe, Auckland, New Zealand

Research Site 3

Takapuna, Auckland, New Zealand

Research Site 1

Auckland, New Zealand

Research Site 2

Christchurch, New Zealand

Research Site 4

Rotorua, New Zealand