Study identification

PURI

https://redirect.ema.europa.eu/resource/105697

EU PAS number

EUPAS104613

Study ID

105697

Official title and acronym

NN9536-4937 Wegovy® (semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy during Pregnancy

DARWIN EU® study

No

Study countries

Spain
United Kingdom
United States

Study description

This is an observational, prospective Wegovy (semaglutide 2.4 milligram mg) Pregnancy Registry Study. The aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to Wegovy during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition with outcomes in an internal comparison cohort of pregnant women with obesity or overweight with at least one weight related comorbid condition at conception and who are not exposed to Wegovy or other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) during pregnancy. Infant outcomes will be assessed throughout the infant’s first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.

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

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S
Study protocol
Initial protocol

4937 16-1-01 protocol eu-pas-reg redacted

English (1.4 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Non-EU RMP only