ObesityPhase 1/2NCT06937203
A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
A Phase 1/2 study testing ARO-ALK7 in people with Obesity and Diabetes Mellitus, Type 2, run by Arrowhead Pharmaceuticals at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- ARO-ALK7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 9 May 2025to Feb 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m^2), inclusive, with weight at Screening not to exceed 159 kg (350 pounds [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
- Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of childbearing potential must agree to use 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
Who cannot join
- Self-reported (or documented) weight gain or loss >5% within 3 months prior to Screening
- Use of glucagon-like peptide-1 receptor agonist (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
- Note: Additional inclusion/exclusion criteria may apply per protocol.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
New Zealand6 sites, 6 recruiting
- Recruiting
Research Site 1
Auckland, 1010
Principle Investigator
- Recruiting
Research Site 2
Christchurch, 8011
Principle Investigator
- Recruiting
Research Site 5
Grafton, Auckland, 1010
Principle Investigator
- Recruiting
Research Site 6
Papatoetoe, Auckland, 2025
Principle Investigator
- Recruiting
Research Site 4
Rotorua, 3010
Principle Principle Investigator
- Recruiting
Research Site 3
Takapuna, Auckland, 0622
Principle Investigator
Australia2 sites, 2 recruiting
- Recruiting
Research Site 8
Morayfield, QLC, 4506
Principle Investigator
- Not yet recruiting
Research Site 7
Nedlands, Western Australia, 6009
Principle Investigator
About this study
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
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).
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- ARO-ALK7, Placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-ALK7Drug
Subcutaneous (SC) injection
PlaceboDrug
Also called 0.9% sodium chloride
calculated volume to match active treatment by SC injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1 and Part 2 (optional cohort): ARO-ALK7 | Experimental | ARO-ALK7 in single (Day 1) or multiple (Days 1 and 85) ascending doses Receives: Drug: ARO-ALK7 |
| Part 1 and Part 2 (optional cohort): Placebo | Placebo comparator | Placebo in single (Day 1) or multiple (Days 1 and 85) matching doses Receives: Drug: Placebo |
| Part:2: ARO-ALK7 + Tirzepatide | Experimental | ARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253 Receives: Drug: ARO-ALK7 |
| Part 2: Placebo + Tirzepatide | Placebo comparator | Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 253 End of Study (EOS)
Secondary outcomes (11)
Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)
Measured: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)
Measured: 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)
Measured: 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)
Measured: 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-∞)
Measured: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2)
Measured: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F)
Measured: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F)
Measured: Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after Dosing (Amount excreted: Ae)
Measured: Through 24 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe)
Measured: Through 24 hours post-dose
PK of ARO-ALK7: Renal Clearance (CLr)
Measured: Through 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start9 May 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937203
- Sponsor's protocol ID
- AROALK7-1001
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No