A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
H. Lundbeck A/S
Study ID
NCT05669950
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Congenital Adrenal Hyperplasia

Eligibility Criteria

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

Interventions

  • Lu AG13909 — DRUG
    Solution for infusion

Study Details

This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. The main goals of this trial are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909.

Key Dates

Start date
Dec 19, 2022
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Lu AG13909
    Participants in Part A will receive multiple intravenous (IV) doses of Lu AG13909 per a prespecified dosing schedule. After data from Part A has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part B will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule. After data from Part B has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part C will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule. Participants from Part C may be eligible to continue in the optional Treatment Extension.

Primary Outcome Measure

Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 161 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospital-University of MichiganAnn ArborMichigan48109-

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By research site
University Hospital-University of Michigan· Ann Arbor, MI

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