Recruiting NCT06937203
A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARO-ALK7, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity, Diabetes Mellitus, Type 2. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug ARO-ALK7
Subcutaneous (SC) injection - Drug Placebo
calculated volume to match active treatment by SC injection
Primary outcome measures
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Day 253 End of Study (EOS)]
Secondary outcome measures (11)
- Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax) [Time frame: Through 48 hours post-dose]
- PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax) [Time frame: 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) [Time frame: 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) [Time frame: 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-∞) [Time frame: Through 48 hours post-dose]
- PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2) [Time frame: Through 48 hours post-dose]
- PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F) [Time frame: Through 48 hours post-dose]
- PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F) [Time frame: 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) [Time frame: 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) [Time frame: Through 24 hours post-dose]
- PK of ARO-ALK7: Renal Clearance (CLr) [Time frame: Through 24 hours post-dose]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
New Zealand · 6 centers
- Research Site 5 — Grafton
- Research Site 6 — Papatoetoe
- Research Site 3 — Takapuna
- Research Site 1 — Auckland
- Research Site 2 — Christchurch
- Research Site 4 — Rotorua
Australia · 2 centers
- Research Site 8 — Morayfield
- Research Site 7 — Nedlands
Identifiers
NCT: NCT06937203 · AROALK7-1001