At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Lu AG13909 (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Lu AG13909 — drug: Solution for injection/infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a medicine called Lu AG13909 in adults with Cushing's Disease, a condition where a small tumour on the pituitary gland causes the body to make too much of a hormone called cortisol. The study is run by the company H. Lundbeck A/S.
Who can take part
- Adults with a confirmed diagnosis of Cushing's Disease caused by too much ACTH (a hormone) from the pituitary gland
- Morning ACTH levels above the normal lower limit
- Proof the extra ACTH comes from the pituitary gland — either an MRI scan showing a pituitary tumour larger than 6 millimetres, a special blood test result, or lab confirmation from tumour tissue
- Urine cortisol levels higher than normal, based on at least 3 days of 24-hour urine collection
- Generally healthy apart from Cushing's Disease and well-controlled conditions such as diabetes or high blood pressure
- If already taking medicine for Cushing's Disease, you must stop it for a set period before the study's starting checks
Who may not be able to
- People who are pregnant, breastfeeding, planning a pregnancy, or able to become pregnant and not willing to use contraception
- Any concerning results on blood tests, heart tracings (ECG), or other safety checks at the screening visit
- Past allergic reactions or intolerance to Lu AG13909 or its ingredients
- Needing pituitary surgery within 6 months of screening
- Severe Cushing's Disease — for example poorly controlled high blood pressure or diabetes, severe mental illness, eyesight problems caused by pressure on nerves near the pituitary, or a very high risk of blood clots
- Pituitary surgery within the 3 months before screening
- Pituitary radiotherapy within the last 10 years
What taking part involves
- • Taking the study medicine Lu AG13909 — how it is given, how often, and for how long is not stated — ask the trial team
- • Screening checks including medical history, physical examination, vital signs, heart tracing (ECG), and blood and urine tests
Time commitment: Number of visits and total study length are not stated — ask the trial team; taking part involves screening tests, stopping any current Cushing's medicines for a set period first, and providing at least 3 days of 24-hour urine samples.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 18
- Started
- 2024-06-19
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for cushing's disease
- • Phase2 - 18 participants
- • This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD)
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with cushing's disease
Where?
- • Manchester - Northern Care Alliance, North Manchester General Hospital
- • Birmingham - University of Birmingham - Institute of Metabolism and Systems Research (IMSR)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about 1. the effect of Lu AG13909 on cortisol levels. 2. the safety and tolerability of Lu AG13909. 3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).
More detail
This trial is divided into 3 parts: * Part A, consisting of 3 periods: an intravenous (IV) Titration Period, a subcutaneous (SC) Period, and a Safety Follow up Period * Part B, consisting of 3 periods: a SC Titration Period, a Maintenance Period, and a Safety Follow-up Period * Extension Period, consisting of a Long-Term Efficacy/Safety Period after Part B and a Safety Follow-up Period
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
What the study is looking for
- ✓The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of...
- ✓Morning plasma ACTH levels \> lower limit of normal (LLN) and
- ✓Evidence of a pituitary origin of the excess ACTH:
- ✓i. Either MRI confirmation of pituitary adenoma \>6 millimeters (mm), or ii. inferior petrosal sinus gradient \>2,...
- ✓The participant has a 24-hour UFC \>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).
Who cannot take part
- ✗The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not...
- ✗The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.
- ✗The participant has immediate need for pituitary surgery within 6 months from screening in the opinion of the...
- ✗The participant has severe CD per investigator judgement; among others, this could be participants with:
- ✗The participant had pituitary surgery \<3 month prior to screening.
See the full criteria
Where Is This Study? (2 UK sites)
Northern Care Alliance, North Manchester General Hospital
Manchester M8 5RB, United Kingdom
University of Birmingham - Institute of Metabolism and Systems Research (IMSR)
Birmingham B15 2TT, United Kingdom
How to Get in Touch
Email contact via H. Lundbeck A/S
Sponsor contactCONTACT
