A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
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
1 other identifier
interventional
138
2 countries
8
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 obesity
Started May 2025
Typical duration for phase_1 obesity
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 13, 2026
February 1, 2026
1.4 years
April 15, 2025
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to Day 253 End of Study (EOS)
Secondary Outcomes (11)
Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Through 48 hours post-dose
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)
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-∞)
Through 48 hours post-dose
- +6 more secondary outcomes
Study Arms (4)
Part 1 and Part 2 (optional cohort): ARO-ALK7
EXPERIMENTALARO-ALK7 in single (Day 1) or multiple (Days 1 and 85) ascending doses
Part 1 and Part 2 (optional cohort): Placebo
PLACEBO COMPARATORPlacebo in single (Day 1) or multiple (Days 1 and 85) matching doses
Part:2: ARO-ALK7 + Tirzepatide
EXPERIMENTALARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253
Part 2: Placebo + Tirzepatide
PLACEBO COMPARATORPlacebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at D15 through D253
Interventions
Eligibility Criteria
You may qualify if:
- 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 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Research Site 8
Morayfield, QLC, 4506, Australia
Research Site 7
Nedlands, Western Australia, 6009, Australia
Research Site 5
Grafton, Auckland, 1010, New Zealand
Research Site 6
Papatoetoe, Auckland, 2025, New Zealand
Research Site 3
Takapuna, Auckland, 0622, New Zealand
Research Site 1
Auckland, 1010, New Zealand
Research Site 2
Christchurch, 8011, New Zealand
Research Site 4
Rotorua, 3010, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2025
First Posted
April 22, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-02