Actively Recruiting
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
Led by H. Lundbeck A/S · Updated on 2026-02-18
18
Participants Needed
26
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Confirmed diagnosis of ACTH-driven Cushing's disease from pituitary source
- Morning plasma ACTH levels above lower limit of normal
- Evidence of pituitary origin of excess ACTH by MRI adenoma >6 mm, inferior petrosal sinus gradient >2, or histopathology confirmation
- 24-hour urinary free cortisol greater than 1.5 times upper limit of normal (mean of at least 3 days)
- Generally healthy apart from Cushing's disease and well-controlled related conditions
- Completed required washout periods from prior hypercortisolism treatments before baseline assessments
You will not qualify if you...
- Pregnant, breastfeeding, intending to become pregnant, or unwilling to use contraception if of child-bearing potential
- Clinically significant abnormal lab values, ECG, vital signs, or safety findings at screening
- Known hypersensitivity or intolerance to Lu AG13909 or its components
- Immediate need for pituitary surgery within 6 months of screening
- Severe Cushing's disease including poorly controlled hypertension, diabetes, severe psychiatric illness, optic chiasm compression with visual defects, or high thromboembolic risk
- Pituitary surgery within 3 months prior to screening
- Pituitary radiotherapy within the past 10 years
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
Centre Hospitalier Universitaire d'Angers
Angers, Cedex 09, France, 49933
Actively Recruiting
3
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, Europe, France, 13005
Actively Recruiting
4
Hopital Louis Pradel
Bron, France, 69677
Actively Recruiting
5
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
6
Centre Hospitalier Universitaire De Lille
Lille, France, 59000
Actively Recruiting
7
Hopital Haut-Leveque
Pessac, France, 33604
Actively Recruiting
8
Ltd Tbilisi Central Hospital
Tbilisi, Europe, Georgia, 0159
Actively Recruiting
9
National Institute of Endocrinology
Tbilisi, Europe, Georgia, 0159
Actively Recruiting
10
Multiprofile Clinic Consilium Medulla Ltd
Tbilisi, Europe, Georgia, 0186
Actively Recruiting
11
Ltd Aversi Clinic
Tbilisi, Georgia, 160
Actively Recruiting
12
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, Hungary, 1083
Actively Recruiting
13
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
14
University Hospital of Pecs
Pécs, Hungary, 7624
Actively Recruiting
15
Azienda Ospedale Università di Padova
Padova, Europe, Italy, 35128
Actively Recruiting
16
Azienda Ospedaliero-Universitaria Pisana
Pisa, Europe, Italy, 56124
Actively Recruiting
17
AOU Policlinico G. Martino
Messina, Italy, 98124
Actively Recruiting
18
Azienda Ospedaliera Universitaria Sant'Andrea
Rome, Italy, 00189
Actively Recruiting
19
AOU Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Actively Recruiting
20
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, Romania, 011863
Actively Recruiting
21
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Clju-Napoca, Romania, 400347
Actively Recruiting
22
Spitalul Clinic Judetean Mures
Mures, Romania, 540139
Actively Recruiting
23
Hospital de la Santa Creu i de Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
24
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
25
Northern Care Alliance, North Manchester General Hospital
Manchester, Europe, United Kingdom, M8 5RB
Actively Recruiting
26
University of Birmingham Institute of Metabolism and Systems Research
Birmingham, United Kingdom
Actively Recruiting
Research Team
E
Email contact via H. Lundbeck A/S
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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