Health Trials

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

ConditionCushing's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorH. Lundbeck A/S

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lu AG13909

    Drug

    Solution for injection/infusion

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Lu AG13909Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
Up to 490 days

Secondary outcomes

1

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

Time frame
Up to 1023 days
2

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

Time frame
Up to 1037 days
3

CL: Systemic Clearance of Lu AG13909

Time frame
Up to 1037 days
4

t½: Elimination Half-life of Lu AG13909

Time frame
Up to 1037 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lundbeck A/S

Lead sponsor

Source ClinicalTrials.gov
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