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

NCT06471829 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 20433A2023-504733-53-00
• Study Type: interventional
• Target: 18
• Locations: 8 countries
• Sites: 26

Brief 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. 1.the effect of Lu AG13909 on cortisol levels.
2. 2.the safety and tolerability of Lu AG13909.
3. 3.the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).

Conditions

Cushing's Disease

Outcome Measures

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

  Up to 490 days

Secondary Outcomes (16)

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

  Up to 1023 days

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

  Up to 1037 days

• CL: Systemic Clearance of Lu AG13909

  Up to 1037 days

• t½: Elimination Half-life of Lu AG13909

  Up to 1037 days

• Vd: Apparent Volume of Distribution of Lu AG13909

  Up to 1037 days

Study Arms (1)

Lu AG13909

EXPERIMENTAL

Participants will first receive Lu AG13909 IV per predefined dosing schedule. Participants will then receive Lu AG13909 SC per predefined dosing schedule.

Drug: Lu AG13909

Interventions

Lu AG13909 DRUG

Solution for injection/infusion

Lu AG13909

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (26)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Centre Hospitalier Universitaire d'Angers

Angers, Cedex 09, 49933, France

RECRUITING

Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception

Marseille, Europe, 13005, France

RECRUITING

Hopital Louis Pradel

Bron, 69677, France

RECRUITING

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Centre Hospitalier Universitaire De Lille

Lille, 59000, France

RECRUITING

Hopital Haut-Leveque

Pessac, 33604, France

RECRUITING

Ltd Tbilisi Central Hospital

Tbilisi, Europe, 0159, Georgia

RECRUITING

National Institute of Endocrinology

Tbilisi, Europe, 0159, Georgia

RECRUITING

Multiprofile Clinic Consilium Medulla Ltd

Tbilisi, Europe, 0186, Georgia

RECRUITING

Ltd Aversi Clinic

Tbilisi, 160, Georgia

RECRUITING

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, 1083, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

RECRUITING

University Hospital of Pecs

Pécs, 7624, Hungary

RECRUITING

Azienda Ospedale Università di Padova

Padua, Europe, 35128, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, Europe, 56124, Italy

RECRUITING

AOU Policlinico G. Martino

Messina, 98124, Italy

RECRUITING

Azienda Ospedaliera Universitaria Sant'Andrea

Rome, 00189, Italy

RECRUITING

AOU Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

Institutul National de Endocrinologie "C.I. Parhon"

Bucharest, 011863, Romania

RECRUITING

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Clju-Napoca, 400347, Romania

RECRUITING

Spitalul Clinic Judetean Mures

Mures, 540139, Romania

RECRUITING

Hospital de la Santa Creu i de Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Northern Care Alliance, North Manchester General Hospital

Manchester, Europe, M8 5RB, United Kingdom

RECRUITING

University of Birmingham Institute of Metabolism and Systems Research

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  HQ_Medinfo@Lundbeck.com

  STUDY DIRECTOR

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

GB (2); GE (4); HU (3); RO (3); IT (5); ES (2); FR (6); US (1)