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NCT07720414RecruitingAccepts Healthy Volunteers

Effects of GLP-1 RAs on Human Lactation Outcomes

University of Colorado, Denver

Start Date

7/1/2026

Completion Date

6/1/2028

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DRUG

Injected GLP-1 Receptor Agonists and Dual Agonists

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Conditions

LactationWeight Loss

Locations

University of Colorado Anschutz School of Medicine

Aurora, Colorado 80045

United States