What this trial means for you
This study is recruiting now at 1 US site. It's studying Injected GLP-1 Receptor Agonists and Dual Agonists for lactation, weight loss.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Colorado
- University of Colorado Anschutz School of Medicine, Aurora · Recruiting now
View the official record on ClinicalTrials.gov →
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