Effects of GLP-1 RAs on Human Lactation Outcomes (NCT07720414) | Clinical Trial Compass
RecruitingNot Applicable
Effects of GLP-1 RAs on Human Lactation Outcomes
United States18 participantsStarted 2026-07
Plain-language summary
There is increasing interest in using GLP-1 Receptor Agonist (GLP-1 RA) medications after pregnancy. This study is designed to determine if these medications affect breastmilk production or the nutritional makeup of breastmilk.
The main questions the study will address are:
* Does GLP-1 RA-induced weight loss increase or decrease breastmilk production?
* Does GLP-1 RA-induced weight loss affect the nutritional composition of milk, including milk fat content?
Researchers will assess milk production rates before and after mothers begin taking injected GLP-1 RA medications to decrease their body weight. Weight loss will be confirmed with 7-day body weight averages.
Participants will:
* Weigh themselves and report measurements daily.
* Participate in 2-3 morning study visits over approx. 2.5-4.5 months (approx. 3-3.5hrs each).
During each visit, participants will:
* Use a study provided breastpump to express milk 3 times hourly for measurement of hourly milk production.
* Provide 1-3 oz of milk for further study.
* Answer questions about breastfeeding patterns.
Who can participate
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:
* Breastfeeding mothers of single or multiple infants.
* Milk removal at least 4x daily
* Eligible for a GLP-1 RA administered subcutaneously (oral GLP-1 RAs contain absorption enhancers, which may drive accumulation in milk)
* Access to a breastpump, if needed for maintaining breastfeeding behaviors.
* Willingness to provide 1-3 oz of breastmilk per study visit.
* Willingness to track and report body weight daily.
* Willingness to maintain breastfeeding behaviors for the duration of the study.
Exclusion Criteria:
* Currently taking GLP-1 RA medication or other weight loss medication
* Induced lactation, due to unknowns regarding the durability of the mammary gland's milk production after exogenous stimulation.
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
Hourly milk production rate
Timeframe: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if their dosage is increased.
2
Milk macronutrient composition
Timeframe: From one week before until a maximum of 2 months after beginning GLP-1RA treatment. This timeframe will restart if the dosage is increased.