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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
H. Lundbeck A/S
Study ID
NCT06471829
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cushing's Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Lu AG13909 — DRUG
    Solution for injection/infusion

Study Details

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).

Key Dates

Start date
Jun 19, 2024
Status verified
Feb 2026
Primary completion
Sep 15, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MI

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