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RECRUITING
NCT06937203
PHASE1/PHASE2

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

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

Summary

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).

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

150

Start Date

2025-05-09

Completion Date

2027-02

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

ARO-ALK7

Subcutaneous (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