DARWIN EU® - Determinants for use of GLP1 receptor agonists – a drug utilisation study

10/11/2025
04/03/2026
EU PAS number:
EUPAS1000000828
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000828

Study ID

1000000828

Official title and acronym

DARWIN EU® - Determinants for use of GLP1 receptor agonists – a drug utilisation study

DARWIN EU® study

Yes

Study countries

Belgium
Croatia
Denmark
Finland
Germany
Netherlands
Norway
Spain
Sweden
United Kingdom

Study description

A shortage of medicines containing Glucagon-Like Peptide-1 receptor agonists (GLP-1 RA) has been
affecting European Union (EU) Member States since 2022. The medicines belonging to the class of GLP-1 RA
are either authorised for the treatment of diabetes or authorised for weight management in patients
diagnosed with obesity, with the exception of Mounjaro (tirzepatide), a glucose-dependent insulinotropic
polypeptide (GIP) and GLP-1 RA that is authorised for both indications.
Increased demand for these medicines has contributed to this shortage in addition to other causes, e.g.,
capacity constraints. Excessive off-label use for cosmetic weight loss of some of these medicines has raised
concerns. This relates to use for weight management in people without obesity or people with overweight
who do not have weight related health problems. This use has been mentioned frequently in the news and
social media and is exacerbating existing shortages with serious consequences for public health.
This study aims to provide an overview of the characteristics of patients prescribed with GLP-1 RA and to
describe the pattern of use, including switching between GLP-1 RA substances and to other antidiabetics, as
well as switching between selected brands. The study will span over 10 years, allowing for the assessment
of potential changes in incidence of use, user characteristics, and treatment patterns. This will help
contextualise what determinants might be driving the demand for GLP-1 RA in relation to the observed
shortage of medicines, including exploring comparative trends of prescription of other medicinal products
used in diabetes and for weight management, as well as patterns of off-label use.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marta Pineda Moncusi

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable