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JOURNAL ONKOLOGIE – STUDIE
GRADIENT

Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

Rekrutierend

NCT-Nummer:
NCT04308590

Studienbeginn:
Juli 2020

Letztes Update:
07.03.2024

Wirkstoff:
relacorilant

Indikation (Clinical Trials):
Adenoma, Adrenocortical Adenoma, Cushing Syndrome, Adrenocortical Hyperfunction

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Corcept Therapeutics

Collaborator:
-

Studienleiter

Andreas Moraitis, MD
Study Director
Corcept Therapeutics

Kontakt

Studienlocations
(3 von 55)

Alle anzeigen

Studien-Informationen

Detailed Description:

This Phase 3 study patients will be randomized in a 1:1 ratio to treatment with relacorilant

(active drug) or placebo. Patients will receive relacorilant or placebo for 22 weeks.

Patients who complete the study may also be eligible to roll over into an extension study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Shows lack of cortisol suppression

- Suppressed or low early-morning ACTH levels

- A radiologically confirmed adrenal lesion

- Has IGT or DM

- Has uncontrolled hypertension

Exclusion Criteria:

- Has severe, uncontrolled hypertension

- Has poorly controlled DM

- Has DM Type 1

- Has significantly abnormal liver test results or severe renal insufficiency

- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Studien-Rationale

Primary outcome:

1. In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm (Time Frame - Baseline to week 22)

2. In patients with systolic hypertension, the change in mean systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitor (ABPM) as compared between relacorilant and placebo arms (Time Frame - Baseline to week 22)

3. Rate of safety based TEAEs (Time Frame - Baseline to week 22):
Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.

Secondary outcome:

1. In patients with DM at baseline the mean change in HbA1c and fasting glucose (Time Frame - Baseline to week 22/ET)

2. Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose (Time Frame - Week 22/ET)

3. Proportion of patients with normalization of the mean SBP (Time Frame - Baseline to week 22/ET)

Studien-Arme

  • Experimental: Relacorilant
    The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.
  • Placebo Comparator: Placebo
    Placebo matched to study drug

Geprüfte Regime

  • relacorilant:
    Relacorilant is supplied as 100 mg capsules for oral dosing.
  • Placebo:
    Placebo is supplied as 100 mg capsules for oral dosing.

Quelle: ClinicalTrials.gov


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