Study identification

EU PAS number

EUPAS104526

Study ID

105300

Official title and acronym

NN8640-4515 A multi-national, multi-centre, prospective, single-arm, observational, non-interventional post-authorisation safety study to investigate long-term safety of Sogroya® (somapacitan) in adults with growth hormone deficiency (AGHD) under routine clinical practice

DARWIN EU® study

No

Study countries

Australia
Brazil
Germany
Saudi Arabia
Slovenia
United Kingdom
United States

Study description

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Study status

Ongoing
Research institutions and networks

Institutions

Novo Nordisk
First published:
01/02/2024
Institution

Contact details

Clinical Transparency (dept. 2834) Novo Nordisk A/S

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)