GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets

A Trial Investigating Semaglutide and SNAC Concentrations in Breastmilk Following Administration of Multiple Doses of Oral Semaglutide in Healthy, Lactating Females

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-32.4•Female•Healthy volunteers

Primary endpoints

•AUC of semaglutide milk during a dosing interval after the 10th dosing•Area under the salcaprozate sodium (SNAC) milk concentration-time curve during

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04817644

Org study IDNN9924-4669

Secondary IDU1111-1253-4467World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-03-26actual

Study start2021-09-10actual

Primary completion2023-05-26actual

Study completion2023-07-03actual

Last update posted2025-03-11actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Healthy, female subjects who have given birth at least 3 months prior to screening and who breastfeed (breastfeeding is defined by feeding the baby milk produced by the mother. Using a breast pump to collect milk and subsequently feeding it to the baby by bottle, is also defined as breastfeeding ) their infant to an extent, where the majority of the infant's total energy intake is from breastfeeding and sufficient milk is produced to fulfil the trial requirements, as judged by the investigator.

•Agree to abstain from breastfeeding their infant from first dose of oral semaglutide to the "End of trial" visit (total of 47 days) to avoid potentially exposing their child to semaglutide and SNAC.

•The breastfed infant is able to feed from a bottle (expenses related to alternative infant nutrition during trial participation will be covered by Novo Nordisk) prior to screening.

•Age above or equal to 18 years at the time of agreement to take part.

•Body mass index (BMI) between 20.0 and 32.4 kg/m^2 (both inclusive).

Exclusion criteria

•Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method.

•Glycated haemoglobin (HbA1c) greater than or equal to 6.5 % (48 mmol/mol) at screening.

•Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.

•History (as declared by the subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject or reported in the medical records).

•Presence or history (as declared by the subject or reported in the medical records) of malignant neoplasm within 5 years prior to the day of screening (basal or squamous cell skin cancer, or any carcinoma in-situ is allowed).

•Presence or history (as declared by the subject or reported in the medical records) of pancreatitis (acute or chronic).

Endpoints (65)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

65 endpoints

Primary/protocol endpoint

Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)