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New treatment option for Cushing's Disease
Official title A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
ClinicalTrials.gov ID: NCT06471829
What this study is testing
What is Lu AG13909?
Lu AG13909 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cushing's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current...
- 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...
- The participant has a 24-hour UFC \>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).
- Apart from CD and associated well-controlled comorbidities (for example, diabetes mellitus and hypertension), the participant is generally healthy in...
You likely can't join if
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate...
- The participant has a clinically significant abnormal laboratory value, ECG parameter, vital signs value, or other safety findings at the Screening...
- 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 investigator.
- The participant has severe CD per investigator judgement; among others, this could be participants with: i. poorly controlled hypertension ii. poorly...
- The participant had pituitary surgery \<3 month prior to screening.
See the full eligibility criteria
- The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current guidelines
- 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, or iii. histopathology confirmation of ACTH-secreting...
- The participant has a 24-hour UFC \>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).
- Apart from CD and associated well-controlled comorbidities (for example, diabetes mellitus and hypertension), the participant is generally healthy in the opinion of the investigator and based on medical history...
- For participants on medical treatment for hypercortisolism due to CD, pre-defined washout periods must be completed prior to the Baseline how well it works assessments.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.
- The participant has a clinically significant abnormal laboratory value, ECG parameter, vital signs value, or other safety findings at the Screening Visit that indicate a potential risk to the participant's safety if...
- 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 investigator.
- The participant has severe CD per investigator judgement; among others, this could be participants with: i. poorly controlled hypertension ii. poorly controlled diabetes mellitus iii. severe psychiatric illness iv...
- The participant had pituitary surgery \<3 month prior to screening.
- The participant had pituitary radiotherapy within the last 10 years. Other protocol-defined criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Angers, Cedex 09, France
- Marseille, Europe, France
- Bron, France
- Le Kremlin-Bicêtre, France
- Lille, France
- Pessac, France
- Tbilisi, Europe, Georgia
- Tbilisi, Georgia
- Budapest, Hungary
- Debrecen, Hungary
- Pécs, Hungary
- Padova, Europe, Italy
- Pisa, Europe, Italy
- Messina, Sicily, Italy
- Rome, Italy
- Torino, Italy
- Krakow, Poland
- Bucharest, Romania
- Clju-Napoca, Romania
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Angers, Cedex 09, France; Marseille, Europe, France; Bron, France; Le Kremlin-Bicêtre, France; Lille, France and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.