Table of contents
- Trial overview
- Who can participate
- What is being measured
- Study design and treatment routes
- Why this trial matters
Trial overview
The available trial is a Phase 2 study of Ag13909 in adult participants with Cushing’s disease.[1] The study is titled “A Trial of Lu AG13909 in Adult Participants with Cushing’s Disease,” and it is listed as Authorised with an enrollment target of 18 people.[1]
This trial is an interventional study, which means the research team gives a treatment and then watches what happens.[1] The trial is designed to learn whether Ag13909 can help control cortisol levels, while also collecting safety and drug-handling information.[1]
Who can participate
The source data says the study is for adult participants with Cushing’s disease.[1] No other detailed entry rules are provided in the trial record, so the exact medical and screening requirements are not available here.[1]
Cushing’s disease is described in the trial summary as a rare and serious disorder in which the body makes too much cortisol.[1] Because the study focuses on this condition, the target group is people who already have this diagnosis.[1]
What is being measured
The main outcome is urinary free cortisol (UFC) complete response, which means the average UFC is at or below the upper limit of normal at the end of the IV/SC titration period.[1] In simple terms, the study is checking whether cortisol in urine returns to a normal range after treatment.[1]
The trial also measures treatment-emergent adverse events, which are health problems that begin or worsen after treatment starts.[1] This helps the researchers understand safety in the study group.[1]
Several pharmacokinetic endpoints are listed as well, which means the study is tracking how the body absorbs and processes Ag13909.[1] These include Cmax (highest blood level), Tmax (time of highest blood level), Ctrough (lowest blood level before the next dose), Ttrough (time of the lowest blood level), AUC0-tau,ss (total drug exposure at steady state), clearance (how fast the drug leaves the body), half-life (how long it takes the amount in the body to drop by half), volume of distribution (how widely the drug spreads in the body), and subcutaneous bioavailability (how much of the drug reaches the bloodstream after being given under the skin).[1]
Study design and treatment routes
The intervention list shows Ag13909 being given by subcutaneous use and intravenous use.[1] Subcutaneous use means under the skin, while intravenous use means into a vein.[1]
The primary outcome time frames extend for a long period, up to 1023 days for safety data and up to 1037 days for some pharmacokinetic measurements.[1] This suggests the study follows participants over time to see both short-term and longer-term results.[1]
Why this trial matters
Cushing’s disease can be serious because too much cortisol affects the whole body.[1] A trial like this is important because it looks at both possible benefit, measured by cortisol control, and safety in the same patient group.[1]
Only one clinical trial record was provided, so the current evidence summary for Ag13909 is based on this single Phase 2 study in adults with Cushing’s disease.[1]
