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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105300
• 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

Study timelines

Date when funding contract was signed

Actual: 15/02/2022

Study start date

Actual: 03/02/2023

Date of final study report

Planned: 15/12/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

4515 16-1-01 protocol eu-pas-reg-redacted

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)

Other study registration identification numbers and links

U1111-1264-8642 NCT05718570