NCT06937203RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 15 Apr 2025
- Start date
- 9 May 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Arrowhead Pharmaceuticals
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06937203
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 150
- From 9 May 2025 to the primary completion date, Feb 2027
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome)
- Type 1 diabetes mellitus
- Note: Additional inclusion/exclusion criteria may apply per protocol.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Morayfield | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Nedlands | Australia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| - Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| - Coordinator of this site? Confirm its status | Grafton | New Zealand | Recruiting |
| - Coordinator of this site? Confirm its status | Papatoetoe | New Zealand | Recruiting |
| - Coordinator of this site? Confirm its status | Rotorua | New Zealand | Recruiting |
| - Coordinator of this site? Confirm its status | Takapuna | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.