A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Wo… (NCT04817644) | Clinical Trial Compass
CompletedPhase 1
A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets
United States14 participantsStarted 2021-09-10
Plain-language summary
Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Histo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)
Timeframe: From 0 to 24 hours after the 10th dosing (day 10)
2
Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk)
Timeframe: From 0 to 24 hours after the 10th dosing (day 10)