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Trial Title:
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
NCT ID:
NCT06471829
Condition:
Cushing's Disease
Conditions: Official terms:
ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lu AG13909
Description:
Solution for injection/infusion
Arm group label:
Lu AG13909
Summary:
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's
disease (CD). Cushing's disease 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).
Criteria for eligibility:
Criteria:
Inclusion 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 >3 after stimulation with corticotropin-releasing hormone
(CRH). Otherwise, >2.
iii. histopathology confirmation of ACTH-secreting tumour
- 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 disease manifestations (for example,
diabetes mellitus and hypertension), the participant is generally healthy in the
opinion of the investigator and based on medical history, physical examination,
vital signs, electrocardiogram (ECG), and the results of the safety laboratory
tests.
- For participants on medical treatment for hypercortisolism due to CD, pre-defined
washout periods must be completed prior to the Baseline efficacy assessments.
Exclusion Criteria:
- 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 enrolled, in the opinion of
the investigator.
- 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:
- poorly controlled hypertension
- poorly controlled diabetes mellitus
- severe psychiatric illness
- compression of the optic chiasm causing any visual field defect or risk thereof
- very high risk of thromboembolic events
- The participant had pituitary surgery <3 month prior to screening.
- The participant had previous pituitary radiotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Institute of Endocrinology
Address:
City:
Tbilisi
Zip:
0159
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Tbilisi Central Hospital
Address:
City:
Tbilisi
Zip:
0159
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Multiprofile Clinic Consilium Medulla
Address:
City:
Tbilisi
Zip:
0186
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Aversi Clinic
Address:
City:
Tbilisi
Zip:
160
Country:
Georgia
Status:
Recruiting
Start date:
June 19, 2024
Completion date:
May 15, 2026
Lead sponsor:
Agency:
H. Lundbeck A/S
Agency class:
Industry
Source:
H. Lundbeck A/S
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06471829
