Metycor study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

1 Aug 2025 → ongoing

Decision date (initial)

2024-11-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk foundation

External identifiers

EU CT number

2024-514143-28-00

EudraCT number

2022-002241-18

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Therapy

Assess improvement in hypertension, glucose metabolism, and cortisol levels in patients with ACS measured before and after a 6 months treatment trial with Metycor.

Secondary objectives 4

1. - Assess improvement in other metabolic parameters (weight, bone health, cholesterol profile) in the patient with ACS before and after a trial treatment period of 6 months with cortisol lowering drugs.
2. - Assess the effect of the trial treatment on mental illness and quality of life (assessed by Cushing QoL, a disease-specific quality of life form for Cushing's syndrome, and general quality of life form SF36), before and after a trial treatment period of 6 months with cortisol lowering drugs.
3. -Assess the effect of the trial treatment on bone health (assessed by bone density measurement at baseline and bone markers -blood tests at time 0, 3 and 6 months, that show whether bone degradation is taking place),before and after a trial treatment period of 6 months with cortisol lowering drugs.
4. --Assess the effect of the trial treatment on BMI, from before compared with after a trial treatment period of 6 months with cortisol lowering drugs.

Conditions and MedDRA coding

Mild autonomous cortisol secretion

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. • Must be at least 18 years of age.
2. • Patients with ACS and one or more metabolic-, bone- and / or psychiatric complications.
3. • The patient is eligible for surgical treatment with adrenalectomy
4. • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion criteria 15

1. • Patients with fulminant Cushing syndrome, who should be given priority for prompt surgery
2. • Patients with pituitary Cushing disease
3. • Patients with low dexamethasone bioavailability as a reason for their positive Dexamethasone suppression test.
4. • Patients using oral estrogens
5. • Patients with adrenal insufficiency
6. • Patients with adrenocortical carsinomas
7. • Patients with co-secretion of aldosterone
8. • Patients with present or previous hearth disease
9. • Patients with electrolyte disturbances
10. • Patients treated with Metycor at present, or before
11. • Patinents treated with other cortisol lowering drugs
12. • Patients hypersensitive/allergic to some of the substances in Metycor
13. • The patient is not able to collaborate on the follow-up in the study
14. • Women who are breastfeeding
15. • Pregnant women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Lowering of s-Cortisol levels by half and/or below 300 nmol/l in basal morning test based on assessments before and after a trial treatment period of 6 months
2. Reduction in Blood pressure with a 10 % reduction in systolic and /or diastolic blood pressure via standard blood pressure measurement and/ or a 5% nocturnal dip measured via 24 h blood pressure measurement based on assessments before and after a trial treatment period of 6 months
3. Significant improvement in glycemic control defined as 5% (5 mmol/mol) reduction in HbA1C, or 10% increase in TIR based on assessments before and after a trial treatment period of 6 months

Secondary endpoints 5

1. Weight reduction of more than 2 kg during the treatment period of 6 months is considered a significant weight reduction
2. There will be a categorically assessment whether there is a change in bone markers (PINP, CTX, osteoklasien) from degradation to build-up of bone, before compared to after treatment for 6 months with Metycor.
3. A 5% decrease in LDL- cholesterol is considered significant after a treatment periode of 6 months with Metycor.
4. Change in score of general quality of life measured as SF36, and disease-specific questionaire Cushing QoL will be assessed individually for each form, and baseline will be compared with 6 months.
5. BMI will be measured/calculated at baseilinge, 3 months and 6 monts. The effect on BMI will be calculated between baseline and 6 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Grethe Åstrøm Ueland

Public contact point

Organisation

Helse Bergen HF

Contact name

Grethe Åstrøm Ueland

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications