Actively Recruiting
A Phase II Open-label Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AG13909 in Adults With Cushing's Disease
Led by H. Lundbeck A/S · Updated on 2026-02-18
18
Participants Needed
26
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Lu AG13909 in adults with Cushing's disease (CD), a rare and serious condition where the body produces too much cortisol hormone. This Phase II trial aims to study how Lu AG13909 affects cortisol levels, its safety and tolerability, and how the drug is absorbed and processed by the body. The sponsor of this trial is H. Lundbeck A/S. The trial has three parts: Part A includes an intravenous (IV) titration period, a subcutaneous (SC) treatment period, and a safety follow-up. Part B involves an SC titration period, a maintenance period, and another safety follow-up. There is also an extension period for long-term efficacy and safety assessment after Part B, followed by a safety follow-up. Participants first receive Lu AG13909 through IV according to a set dosing schedule, then switch to SC dosing as planned. Participants will undergo regular monitoring including urine cortisol measurements to assess treatment response. Researchers will track safety through laboratory tests, ECGs, vital signs, and adverse events up to several years. Pharmacokinetic assessments will evaluate how the drug behaves in the body. The main outcome is the reduction of urinary free cortisol to normal levels by the end of the titration periods. The total study duration can extend up to around three years, including long-term follow-up for safety and effectiveness.
CONDITIONS
Brief Title
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women diagnosed with ACTH-driven Cushing's disease from the pituitary
- Morning plasma ACTH levels above the lower limit of normal
- Evidence of pituitary origin of excess ACTH by MRI, sinus gradient, or tumor pathology
- 24-hour urinary free cortisol more than 1.5 times the upper normal limit
- Generally healthy except for well-controlled related conditions like diabetes or hypertension
- Completed required washout periods if on treatment for hypercortisolism
You will not qualify if you...
- Pregnant, breastfeeding, planning pregnancy, or unwilling to use contraception if of child-bearing potential
- Clinically significant abnormal lab values, ECG, or vital signs posing safety risks
- Known allergy or intolerance to Lu AG13909 or its components
- Immediate need for pituitary surgery within 6 months
- Severe Cushing's disease with uncontrolled hypertension, diabetes, psychiatric illness, optic nerve compression, or high thromboembolic risk
- Pituitary surgery within 3 months prior to screening
- Pituitary radiotherapy within the last 10 years
- Other protocol-defined exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 490 days
Participants receive intravenous (IV) Lu AG13909 following a predefined dosing schedule during the titration period.
Visits scheduled according to dosing and assessment needs during IV titration
Duration - Up to 337 days for the maintenance period within Part B
Participants receive subcutaneous (SC) Lu AG13909 following a predefined dosing schedule during the SC titration and maintenance periods.
Visits scheduled according to dosing and assessment needs during SC titration and maintenance
Duration - Up to approximately 1023 days
Participants are monitored for safety after completing the treatment periods, including a long-term efficacy and safety assessment.
Periodic safety follow-up visits
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
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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