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Looking for participantsPhase2

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

Sponsor: H. Lundbeck A/S

NCT ID: NCT06471829

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Lu AG13909 (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
Lu AG13909 — drug: Solution for injection/infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a medicine called Lu AG13909 in adults with Cushing's Disease, a condition where a small tumour on the pituitary gland causes the body to make too much of a hormone called cortisol. The study is run by the company H. Lundbeck A/S.

Who can take part

  • Adults with a confirmed diagnosis of Cushing's Disease caused by too much ACTH (a hormone) from the pituitary gland
  • Morning ACTH levels above the normal lower limit
  • Proof the extra ACTH comes from the pituitary gland — either an MRI scan showing a pituitary tumour larger than 6 millimetres, a special blood test result, or lab confirmation from tumour tissue
  • Urine cortisol levels higher than normal, based on at least 3 days of 24-hour urine collection
  • Generally healthy apart from Cushing's Disease and well-controlled conditions such as diabetes or high blood pressure
  • If already taking medicine for Cushing's Disease, you must stop it for a set period before the study's starting checks

Who may not be able to

  • People who are pregnant, breastfeeding, planning a pregnancy, or able to become pregnant and not willing to use contraception
  • Any concerning results on blood tests, heart tracings (ECG), or other safety checks at the screening visit
  • Past allergic reactions or intolerance to Lu AG13909 or its ingredients
  • Needing pituitary surgery within 6 months of screening
  • Severe Cushing's Disease — for example poorly controlled high blood pressure or diabetes, severe mental illness, eyesight problems caused by pressure on nerves near the pituitary, or a very high risk of blood clots
  • Pituitary surgery within the 3 months before screening
  • Pituitary radiotherapy within the last 10 years

What taking part involves

  • • Taking the study medicine Lu AG13909 — how it is given, how often, and for how long is not stated — ask the trial team
  • • Screening checks including medical history, physical examination, vital signs, heart tracing (ECG), and blood and urine tests

Time commitment: Number of visits and total study length are not stated — ask the trial team; taking part involves screening tests, stopping any current Cushing's medicines for a set period first, and providing at least 3 days of 24-hour urine samples.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
18
Started
2024-06-19
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for cushing's disease
  • • Phase2 - 18 participants
  • • This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD)

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with cushing's disease

Where?

  • • Manchester - Northern Care Alliance, North Manchester General Hospital
  • • Birmingham - University of Birmingham - Institute of Metabolism and Systems Research (IMSR)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

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

Cushing's Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

What the study is looking for

  • ✓The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of...
  • ✓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,...
  • ✓The participant has a 24-hour UFC \>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).

Who cannot take part

  • ✗The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not...
  • ✗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...
  • ✗The participant has severe CD per investigator judgement; among others, this could be participants with:
  • ✗The participant had pituitary surgery \<3 month prior to screening.
See the full 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 \>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. 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: i. 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 * 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.

Where Is This Study? (2 UK sites)

Northern Care Alliance, North Manchester General Hospital

Manchester M8 5RB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Katie Doyle

RDResearch@nca.nhs.uk---

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

Birmingham B15 2TT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

How to Get in Touch

Email contact via H. Lundbeck A/S

Sponsor contact

CONTACT

+45 36301311 HQ_Medinfo@Lundbeck.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08