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Cushing's DiseasePhase 2BalanCeDNCT06471829

A Trial of Lu AG13909 in Adult Participants With Cushing's Disease

A Phase 2 study testing Lu AG13909 in people with Cushing's Disease, run by H. Lundbeck A/S at 27 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cushing's Disease
What is being tested?
Lu AG13909
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
27 sitesin 9 countries
Study dates
19 Jun 2024to 31 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Either MRI confirmation of pituitary adenoma >6 millimeters (mm), or ii. inferior petrosal sinus gradient >2, or 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 comorbidities (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.

Who cannot join

  • 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 ii. poorly controlled diabetes mellitus iii. severe psychiatric illness iv. compression of the optic chiasm causing any visual field defect or risk thereof v. very high risk of thromboembolic events
Show all 9Show fewer
  • 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.

Trial locations and contacts

27 sites in 9 countries.

27 sites in 9 countries

France6 sites

  • Centre Hospitalier Universitaire d'Angers - Centre de recherche clinique

    Angers, Pays de la Loire Region, 49933

  • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel - Centre De Reference Maladie De Rendu-Osler

    Bron, Auvergne-Rhône-Alpes, 69677

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Centre Hospitalier Universitaire de Lille (CHU Lille)

    Lille, Hauts-de-France, 59000

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Conception - Pole Psychiatrie C...

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

    Pessac, New Aquitaine, 33604

Other trials in France

Italy5 sites

  • Azienda Ospedaliera Universitaria "Gaetano Martino" - Messina

    Messina, 98125

  • Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Ospedale Busonera

    Padua, 35128

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...

    Pisa, 56126

  • Sapienza Universita di Roma - Azienda Ospedaliera Sant Andre

    Rome, 00189

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Sant'Anna

    Turin, 10126

Other trials in Italy

Georgia3 sites

  • Aversi Clinic - Tbilisi

    Tbilisi, 0159

  • Multiprofile Clinic - Consilium Medulla

    Tbilisi, 0186

  • Aversi Clinic - Tbilisi

    Tbilisi, 160

Other trials in Georgia

Hungary3 sites

  • Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika)

    Budapest, 1083

  • Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika

    Debrecen, Hajdú-Bihar, 4032

  • Pecsi Tudomanyegyetem (PTE) (University of Pecs)

    Pécs, Baranya, 7622

Other trials in Hungary

Romania3 sites

  • Institutul National de Endocrinologie "C.I. Parhon"

    Bucharest, 11863

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, Cluj, 400006

  • Spitalul Clinic Judetean Mures (SCJM)

    Târgu Mureş, Mureș County, 540072

Other trials in Romania

United States2 sites

  • University of Michigan Health-A. Alfred Taubman Health Care Center

    Ann Arbor, Michigan, 48109

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110-1010

Other trials in United States

Spain2 sites

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

Other trials in Spain

United Kingdom2 sites

  • University of Birmingham - Institute of Metabolism and Systems Research (IMSR)

    Birmingham, West Midlands, B15 2TT

  • Northern Care Alliance NHS Foundation Trust - North Manchester General Hospital

    Manchester, Europe, M8 5RB

Other trials in United Kingdom

Poland1 site

  • Uniwersytet Jagiellonski Collegium Medicum - Szpital Uniwersytecki w Krakowie - Katedra i Klinika...

    Krakow, Lesser Poland Voivodeship, 30-688

Other trials in Poland

About this study

Official title: A Phase II, Multi-site, Open-label, Dose-titration Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AG13909 in Adults With Cushing's Disease

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).
Read the detailed description

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
Being tested
Lu AG13909
Medical subject headings
Pituitary ACTH Hypersecretion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lu AG13909Drug

    Solution for injection/infusion

Study groups in NCT06471829
Study groupRoleWhat they receive
Lu AG13909ExperimentalParticipants will first receive Lu AG13909 IV per predefined dosing schedule. Participants will then receive Lu AG13909 SC per predefined dosing schedule.
Receives: Drug: Lu AG13909

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period

    Measured: Up to 490 days

Secondary outcomes (16)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to 1415 days

  2. AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State

    Measured: Up to 1429 days

  3. CL: Systemic Clearance of Lu AG13909

    Measured: Up to 1429 days

  4. t½: Elimination Half-life of Lu AG13909

    Measured: Up to 1429 days

  5. Vd: Apparent Volume of Distribution of Lu AG13909

    Measured: Up to 1429 days

  6. SC Bioavailability (F) of Lu AG13909

    Measured: Up to 1429 days

  7. Number of Participants With Anti-Drug Antibodies (ADAs)

    Measured: Up to 1429 days

  8. Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909

    Measured: Up to 323 days

  9. Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909

    Measured: Up to 323 days

  10. Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909

    Measured: Up to 659 days

  11. Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough

    Measured: Up to 659 days

  12. UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the End of the IV/SC Titration Period

    Measured: Up to 491 days

  13. Maintenance of UFC Complete Response (mUFC ≤ULN) at the End of the Part B Maintenance Period

    Measured: Up to 337 days

  14. Part A and Part B: Percentage Change from Baseline in mUFC at the End of the Titration Period and the Completion Visit

    Measured: Baseline, up to 561 days

  15. Part A and Part B: UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the Completion Visit

    Measured: Up to 561 days

  16. Part A and Part B: Late Night Salivary Cortisol (LNSC) Complete Response (Mean LNSC (mLNSC)≤ULN) or Partial Response (≥50% Reduction from Baseline in LNSC and mLNSC >ULN) at the End of the Titration Period and the Completion Visit

    Measured: Up to 561 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start19 Jun 2024
  3. Primary completion10 Aug 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06471829
Sponsor's protocol ID
20433A
Other IDs
2023-504733-53-00, 2023
Acronym
BalanCeD
Status last verified
Oct 2026
First submitted
18 Jun 2024
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lu AG13909 in people with Cushing's Disease, run by H. Lundbeck A/S at 27 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in France, Italy, Georgia, Hungary, Romania and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period (time frame: Up to 490 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06471829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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